[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Asian Institute of Gastroenterology, India\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":574},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,44,0,25,[9,48,80,111,137,158,181,203,223,242,270,290,318,338,360,376,394,418,437,462,479,496,512,532,553],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100053727","phase-3-comparative-study-to-evaluate-microbial-versus-porcine-pancreatic-enzyme-therapy-in-chronic-pancreatitis-100053727",false,"NCT07697352","Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis","A Randomised, Double-Blind, Non-Inferiority Trial Comparing Microbial and Porcine Pancreatic Enzyme Replacement Therapy in Chronic Pancreatitis","NP-PERT","Inclusion Criteria:\n\n* CP fulfilling the M-ANNHEIM criteria 11 with documented PEI (defined as fecal elastase \\\u003C100 µg\u002Fg stool on the background of morphological changes of CP).\n* Willingness to undergo a 2-week wash-out period without pancreatic enzyme therapy before enrolment.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Major psychiatric illness impairing study participation.\n* Systemic illness affecting digestion or study outcomes.\n* Any condition deemed unsuitable for study participation by the investigator.\n* Concurrent acute exacerbation of the CP at the time of screening.","ALL","18 Years",{"count":21,"type":22},134,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Background: Chronic pancreatitis (CP) is a progressive inflammatory disorder causing irreversible pancreatic damage, eventually resulting in pancreatic exocrine insufficiency (PEI). This may lead to malabsorption, malnutrition, weight loss, and impaired quality of life. Pancreatic enzyme replacement therapy (PERT) is the standard treatment for PEI and is predominantly derived from porcine sources. However, religious, ethical, dietary, and supply-related concerns highlight the need for effective non-porcine alternatives. Microbial (fungal)-based pancreatic enzymes have shown promising safety and efficacy in preliminary studies, but evidence in CP remains limited.\n\nObjective: To compare the efficacy and safety of non-porcine microbial (fungal)-based pancreatin with standard porcine-based pancreatin in patients with PEI secondary to CP.\n\nMethods: This investigator-initiated, randomized, double-blind, single-center, non-inferiority trial will enroll 134 adults with CP-associated PEI (defined as having a fecal elastase \\\u003C100 µg\u002Fg). After a two-week washout period, participants will be randomized 1:1 to receive either microbial-based or porcine-based pancreatin for 12 weeks. The primary outcome is the change from baseline in the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) score at 12 weeks. Secondary outcomes include nutritional status, anthropometric measures, gastrointestinal symptoms, pain scores, stool consistency, glycaemic parameters, laboratory markers, and quality of life.\n\nDiscussion: This study aims to evaluate whether microbial-based pancreatin is non-inferior to porcine-based therapy and may provide a culturally acceptable and sustainable alternative for managing CP-related PEI.",[28,29],"Pancreatitis, Chronic","Exocrine Pancreatic Insufficiency (EPI)",[31,32,33,34,35],"chronic pancreatitis","exocrine pancreatic insufficiency","Pancreatic enzyme replacement therapy","porcine pancreatic enzyme","microbial (fungal) pancreatic enzyme","NOT_YET_RECRUITING","2026-07-05",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":22},"2026-08",{"date":44,"type":22},"2027-09",{"name":46,"class":47},"Asian Institute of Gastroenterology, India","OTHER",{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100641301","restoregi-study-regenerative-endoscopic-stromal-therapy-outcomes-and-risk-factor-evaluation-in-gi-fistulas-100641301","NCT07661043","RESTOREGI Study: Regenerative Endoscopic Stromal Therapy: Outcomes and Risk Factor Evaluation in GI Fistulas","PROSPECTIVE RISK FACTOR ANALYSIS OF CLINICAL OUTCOMES FOLLOWING ENDOSCOPIC tSVF-em THERAPY FOR BENIGN GASTROINTESTINAL FISTULAS - RESTOREGI Study","RESTORE-GI","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed benign gastrointestinal fistula involving the luminal gastrointestinal tract\n* Fistula accessible for endoscopic evaluation and treatment\n* Planned treatment with endoscopic tSVF-EM therapy, with or without adjunctive endoscopic therapies (argon plasma coagulation \\[APC\\], tract abrasion\u002Fcurettage, clips, over-the-scope clips \\[OTSC\\], endoscopic suturing, or stent placement)\n* Ability and willingness to provide written informed consent\n* Willingness to comply with scheduled follow-up visits and study assessments\n\nExclusion Criteria:\n\n* Perianal fistulas of any aetiology\n* Inflammatory bowel disease-associated fistulas, including fistulas related to Crohn's disease or ulcerative colitis\n* Malignancy-related fistulas\n* Fistulas requiring primary oncologic surgical management\n* Uncontrolled sepsis or undrained abscess at baseline (patients may become eligible following adequate drainage and clinical stabilisation)\n* Contraindication to adipose tissue harvest, sedation, anaesthesia, or therapeutic endoscopy\n* Pregnancy or lactation\n* Severe coagulopathy not correctable prior to intervention\n* Inability to provide informed consent\n* Anticipated inability to complete study follow-up\n* Participation in another interventional study that may influence fistula healing outcomes",{"count":57,"type":22},50,[59],"NA","RESTOREGI Study Benign gastrointestinal fistulas are abnormal communications between the gastrointestinal tract and adjacent organs or the skin. Chronic fistulas are often difficult to treat because of persistent inflammation, fibrosis, impaired vascularity, and defective tissue regeneration. Endoscopic regenerative therapy using mechanically processed autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM) has emerged as a novel therapeutic approach that may promote tissue repair through angiogenesis, immunomodulation, and regenerative signaling.\n\nAlthough early clinical experience suggests promising healing outcomes, factors predicting successful fistula closure remain poorly understood. The RESTOREGI study is a prospective, single-center observational cohort study designed to identify patient-related, fistula-related, and procedural factors associated with successful healing following endoscopic tSVF-EM therapy in benign gastrointestinal fistulas. The study will also evaluate treatment safety, time to healing, recurrence rates, and the impact of procedural variables on outcomes.",[62,63,64],"Fistula","Regenerative Medicine","Stromal Vascular Fraction",[66,67,68,69,70],"Gastrointestinal fistula","Stromal vascular fraction","Endoscopic fistula closure","Regenerative endoscopy","Mesenchymal stromal cells","2026-06-22",{"date":73,"type":40},"2026-06-24",{"date":75,"type":22},"2026-06-15",{"date":77,"type":22},"2027-08-31",{"name":46,"class":47},1,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":79},"100644132","composite-index-for-outcome-burden-in-acute-cholangitis-100644132","NCT07667166","Composite Index for Outcome Burden in Acute Cholangitis","Development and Internal Validation of a Multidimensional Composite Index for Outcome Burden in Acute Cholangitis: A Multicentre Retrospective Cohort Study in India","CHOLINDEX-01","Inclusion Criteria\n\n* Age 18 to 80 years\n* Hospital admission with definite diagnosis of acute cholangitis meeting TG18 diagnostic criteria\n* TG18 Grade I (Mild) Grade II (moderate) or Grade III (severe) at presentation\u002Fadmission or prior to drainage.\n* Underwent biliary drainage attempt (ERCP\u002FPTBD\u002FEUS-BD) or were planned for drainage (including failures with rescue drainage).\n* First episode of index BD in case of patients undergoing multiple episodes of index BD as per operational definitions (Technical supplement 1)\n* Planned repeat BD in same admission shall be considered as continuation of the index BD and all the procedural details shall be documented and analysed.\n\nExclusion Criteria\n\n* Pregnant women\n* Missing key outcome data (minimum required: mortality status + ICU admission status + Length of stay)\n* Non-biliary sepsis without evidence of biliary obstruction\u002Finfection on review.\n* A patients with past history of BD outside the study setting (As this is akin to second episode of Index BD)\n* Subsequent episodes of Index BD (other than the first index BD episode) among patients with more than one episode of Index BD.","80 Years",{"count":90,"type":22},514,"OBSERVATIONAL","The goal of this retrospective observational study is to construct a composite outcome to measure the success of treatment in patients who are presenting with acute cholangitis (blockage and infection of bile ducts) and undergoing a drainage procedure with different modalities. The study is not intended to test any predetermined hypothesis and does not have any comparison group. The participants' data are collated from retrospective hospital records and analysed for the purpose of the study. All the procedures are in place to ensure the confidentiality of the study participants while collating, analysing and sharing study findings.",[94,95],"Acute Cholangitis","Biliary Drainage",[97,98,99,100,101,102],"Acute cholangitis","Biliary drainage","ERCP","PTBD","EUSBD","Composite outcome","RECRUITING","2026-06-19",{"date":73,"type":40},{"date":107,"type":40},"2026-04-20",{"date":109,"type":22},"2026-07-31",{"name":46,"class":47},{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100641957","regenerative-endoscopy-in-refractory-perianal-crohns-disease-100641957","NCT07652632","Regenerative Endoscopy in Refractory Perianal Crohn's Disease","Autologous Mechanical tSVF Injection in Refractory Perianal Fistulizing Crohn's Disease: A Single Arm Pilot Feasibility Study","REPAIR-pCD","Inclusion Criteria:\n\n* Age 18-65 years\n* Crohn's disease with complex perianal fistula (≥1 secondary tract or internal opening involvement)\n* Refractory to ≥1 biologic and\u002For ≥1 prior sphincter sparing procedure\n* No abscess on screening MRI\n* Mild or no proctitis on endoscopic assessment\n* CDAI \\\u003C220\n* Stable IBD therapy ≥8 weeks\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Rectovaginal fistula\n* Severe active proctitis requiring urgent escalation\n* Malignancy in tract or pelvic region\n* Pregnancy or lactation\n* ASA IV status or bleeding disorder\n* MRI contraindications","65 Years",{"count":57,"type":22},[59],"Perianal fistulizing Crohn's disease (pCD) represents a severe phenotype of Crohn's disease, affecting approximately 20-30% of patients and resulting in chronic drainage, recurrent sepsis, impaired continence, and reduced quality of life. Despite optimization of biologics, antibiotics, and surgical drainage, durable healing remains difficult to achieve. Conventional surgical approaches such as curettage or seton management alone yield modest remission rates, and repeated procedures may compromise sphincter integrity.\n\nAutologous mechanically processed tissue stromal vascular fraction (tSVF) is derived from adipose tissue using non enzymatic methods and can be prepared and reinjected during the same operative session. Unlike culture-expanded or enzymatically isolated cell products, mechanical tSVF retains a native adipose micro architecture containing stromal cells, perivascular elements, endothelial progenitors, extracellular matrix components, and bioactive cytokines. This heterogeneous microenvironment is hypothesized to exert immunomodulatory, pro angiogenic, and regenerative effects that may enhance tract healing while preserving sphincter function.\n\nMechanical processing avoids enzymatic digestion, cell expansion, and complex laboratory infrastructure, making it potentially more feasible and cost effective in real world settings. However, high quality prospective data evaluating mechanically processed autologous tSVF specifically in refractory complex pCD remain limited, and feasibility data are required before undertaking a large randomized trial.\n\nThis single arm pilot feasibility study is therefore designed to evaluate procedural feasibility, safety, and preliminary signals of clinical and radiological healing following mechanical tSVF injection in refractory complex perianal Crohn's disease. The results will inform design parameters, outcome variability, and sample size estimation for a future definitive multicenter trial.",[124,125],"Crohn Disease (CD)","Perianal Crohns Disease",[127,128],"tSVF","REPAIR-CD","2026-06-11",{"date":131,"type":40},"2026-06-17",{"date":107,"type":40},{"date":134,"type":22},"2028-03",{"name":46,"class":47},2,{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":99,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":79},"100642104","a-combination-of-rectal-indomethacin-and-cold-water-exposure-of-the-ampulla-after-ercp-is-superior-to-rectal-indomethacin-alone-in-reducing-the-incidence-of-post-ercp-pancreatitis--rct-100642104","NCT07574970","A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF POST-ERCP PANCREATITIS -RCT","A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF PEP","Inclusion Criteria:\n\n1. Standard ERCP indication\n2. Consent given\n\nExclusion Criteria:\n\n1. Pregnancy and lactation\n2. Chronic calcific pancreatitis \u002F pancreatic divisum \u002F pancreatic head\n3. malignancy \u002F acute pancreatitis within 14 days of ERCP\n4. ERCP for biliary\u002Fpancreatic stent exchange or removal or prior biliary sphincterotomy\n5. Chronic kidney disease with GFR \\\u003C30 or acute kidney injury.\n6. Presence of rectal anomaly\n7. Active GI bleeding or high bleeding risk precluding NSAIDs;platelet \\\u003C50000\u002FL;INR \\>1.5 not correctable\n8. NSAID allergy\n9. Cirrhosis Child-Pugh C\n10. Temp instability or severe cardiopulmonary disease precluding cooling\u002Fshock risk.\n11. Sphincter of Oddi dysfunction (Type 3)","60 Years",{"count":146,"type":22},150,"Endoscopic retrograde cholangiopancreatography (ERCP) has emerged as the primary modality in the management of biliary and pancreatic disease. The complications occurring from ERCP can range from mild to fatal. Procedure related complications are Pancreatitis , Bleeding , Infections- Cholangitis, Cholecystitis , Perforations of which Post-ERCP pancreatitis (PEP) is the most common serious adverse event. Reported incidence of PEP is 8.6-10.7% according to studies(overall RCTs).In India it is 6.6% (2020 study). Prevention as well as early detection and management of PEP results in a satisfactory outcome. Multiple RCTs and meta-analyses show rectal indomethacin\u002Fdiclofenac significantly reduce PEP in average- and high-risk patients; now recommended by ASGE\u002FESGE for nearly all ERCPs. Other measures for prevention of PEP are prophylactic pancreatic duct stents in high-risk anatomy\u002Finstrumentation; wire-guided cannulation; minimizing PD contrast; periprocedural aggressive lactated Ringer's hydration. Cryoprevention effect was shown to reduce postprocedure papillary edema and thus lower the risk of PEP\n\n1. Rectal NSAIDs reduce but do not eliminate PEP.\n2. Cold-water ampullary cooling is biologically plausible but under-studied.\n3. First study to demonstrate if combination of rectal indomethacin and cold-water irrigation may have a synergistic effect.\n4. First study in Indian population.",[149],"Pancreas Disease","2026-06-10",{"date":152,"type":40},"2026-06-12",{"date":154,"type":40},"2025-12-01",{"date":156,"type":22},"2026-12-30",{"name":46,"class":47},{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":165,"sex":18,"minAge":166,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":79},"100630349","a-multicentre-observational-cross-sectional-study-of-the-gastric-precancerous-epithelial-pathway-using-high-definition-endoscopy-and-histopathology-in-india-100630349","NCT07486518","A Multicentre Observational Cross-Sectional Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India","IND-PREP","1. Adults aged ≥40 years undergoing upper gastrointestinal endoscopy for dyspepsia or other clinical indications (nonalarming and alarming symptoms both).\n2. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Known gastric malignancy.\n2. Prior gastric surgery (excluding H. pylori eradication).\n3. Contraindications to endoscopy or biopsy.\n4. Known hereditary gastric cancer syndromes.",true,"40 Years",{"count":168,"type":22},4000,"To estimate the prevalence of histologically confirmed early gastric cancer (EGC) in an Indian multicentre cohort undergoing standardised high-quality upper gastrointestinal endoscopy. EGC is defined as gastric adenocarcinoma confined to the mucosa or submucosa (T1), irrespective of lymph node status, based on histopathology.",[171,172],"Gastric Adenocarcinoma","Early Gastric Cancer","2026-06-02",{"date":175,"type":40},"2026-06-04",{"date":177,"type":22},"2026-07-01",{"date":179,"type":22},"2028-07-01",{"name":46,"class":47},{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":79},"100580290","comparative-assessment-of-esophagitis-in-cases-with-and-without-esophageal-motility-disorders-a-prospective-study-100580290","NCT06835374","Comparative Assessment of Esophagitis in Cases With and Without Esophageal Motility Disorders: A Prospective Study","Comparative Assessment of Reflux Esophagitis in Cases With and Without Esophageal Motility Disorders","Inclusion Criteria:\n\n1. Age≥18y,\n2. confirmed diagnosis of Achalasia,\n3. No contraindication to POEM,\n4. erosive esophagitis on endoscopy\n\nExclusion Criteria:\n\n1. Non-esophageal esophageal motility disorders,\n2. Treatment other than POEM,\n3. current PPI use before assessment for GERD","75 Years",{"count":190,"type":22},200,[59],"Achalasia is a neuro-degenerative disorder marked by changes in the peristalsis of the esophagus and the lack of relaxation in the lower esophageal sphincter (LES), thought to be due to damage to the myenteric plexus with an unknown cause.1 Per-oral endoscopic myotomy (POEM) is an established endoscopic treatment modality for achalasia. Leading gastrointestinal (GI) societies endorse POEM as one of the primary treatment option for achalasia.This study aims to characterize and compare the morphological characteristics of reflux related erosions after the POEM procedures versus those in cases without esophageal motility disorders.\n\nData collection\n\n1. Demographic characteristics: Age, gender, type of achalasia\n2. Manometry findings (pre and post POEM): integrated relaxation pressure, lower esophageal sphincter pressure\n3. Comorbidities\n4. Medications\n5. Eckardt score: before procedure and 3-months after Procedure\n6. POEM procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay\n7. Evaluation at 3-months Symptom: standardized questionnaire (GERDQ) Endoscopy: grade of esophagitis Erosions vs ulcers Dimension of erosions Anatomical location (according to clock)",[194],"Esophageal Diseases","2026-05-30",{"date":197,"type":40},"2026-06-03",{"date":199,"type":40},"2024-05-11",{"date":201,"type":22},"2027-05-10",{"name":46,"class":47},{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":88,"enrollmentInfo":210,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":136},"100626157","prospective-evaluation-of-the-carbon-footprint-and-clinical-utility-of-ibus-compared-to-colonoscopy-and-enterography-in-uc-and-cd-100626157","NCT07431983","Prospective Evaluation of the Carbon Footprint and Clinical Utility of IBUS Compared to Colonoscopy and Enterography in UC and CD","Prospective Evaluation of the Carbon Footprint and Clinical Utility of Intestinal Bowel Ultrasound Compared to Colonoscopy and Enterography in Ulcerative Colitis and Crohn's Disease","All consecutive patients undergoing endoscopy procedures with consent for procedures, during the study period will be included",{"count":190,"type":22},"Healthcare contributes approximately 4.4% of global GHG emissions, with diagnostic imaging and endoscopic services being substantial contributors. Colonoscopy and cross-sectional imaging modalities, though indispensable, are associated with high carbon emissions due to electricity use, waste, sterilisation, and transportation. IBUS, a non-invasive, real-time diagnostic modality, is increasingly validated for disease activity assessment in both UC and CD.",[213,214],"Ulcerative Colitis (UC)","Crohns Disease","2026-05-11",{"date":217,"type":40},"2026-05-12",{"date":219,"type":40},"2026-03-01",{"date":221,"type":22},"2026-12",{"name":46,"class":47},{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":119,"enrollmentInfo":230,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":79},"100640898","a-randomized-controlled-trial-comparing-underwater-versus-conventional-preventive-coagulation-for-intraprocedural-vessel-management-during-peroral-endoscopic-myotomy-100640898","NCT07575295","A Randomized Controlled Trial Comparing Underwater Versus Conventional Preventive Coagulation for Intraprocedural Vessel Management During Peroral Endoscopic Myotomy","POEM","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Diagnosis of achalasia or esophageal motility disorder planned for POEM\n3. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Anticoagulant or antithrombotic therapy not safely stoppable\n2. Known coagulopathy or platelet disorder\n3. Esophageal\u002Fgastric varices\n4. Previous POEM or Heller's myotomy\n5. Prior treatment for same condition\n6. Inability or refusal to consent\n7. Visualized vessels smaller than the HK inner diameter (1.2 mm)",{"count":231,"type":22},120,"Peroral Endoscopic Myotomy (POEM) has become an established, minimally invasive therapy for achalasia and esophageal motility disorders. Submucosal tunnelling is a critical phase of POEM and requires meticulous haemostasis to avoid bleeding, loss of orientation, reduced visibility, and prolonged procedural time.\n\nThe current standard method of vessel coagulation during POEM involves conventional coagulation under CO₂ insufflation using the hybrid knife (HK). However, this approach can require additional hemostatic devices-most commonly coagulation forceps-particularly when dealing with large-calibre vessels or resistant bleeding.\n\nA novel technique-underwater preventive coagulation-leverages water as a conductive medium. Preliminary evidence suggests that:\n\n* electrosurgical current in water is focalized at the interface of the vessel,\n* allowing a soft sealing of the vessel wall,\n* reducing the risk of vessel rupture or unintended deep thermal injury,\n* and potentially eliminating the need to convert to coagulation forceps. Pilot data from our center demonstrate that underwater prophylactic sealing of large vessels during POEM is feasible, safe, and associated with markedly reduced need for rescue coagulation forceps. The technique is already used in practice but lacks systematic evidence from prospective randomized trials.\n\nThis study is designed to provide high-quality evidence on whether underwater vessel coagulation improves haemostatic efficiency, reduces intra-procedural bleeding, and minimizes device changes during POEM.\n\nAll POEM procedures will be performed under general anesthesia in the supine position using Fujifilm high-definition gastroscopes with a 2.8 mm channel and transparent distal cap.\n\nSteps (Both Arms)\n\n1. Identify the esophagogastric junction (EGJ).\n2. Inject saline + methylene blue submucosally.\n3. Create a 2 cm mucosal incision at 5-6 o'clock position, 10 cm above EGJ.\n4. Enter the submucosal space.\n5. Perform submucosal tunnelling down to EGJ and 2-3 cm into cardia.\n6. Perform vessel haemostasis according to group allocation:\n\n   * Underwater coagulation (intervention)\n   * CO₂-based conventional coagulation (control)\n7. Perform circular myotomy (with occasional full-thickness myotomy when indicated).\n8. Close the mucosal entry using hemostatic clips.\n9. Record procedure time, instrument exchanges, bleeding events, and forceps usage.\n\nEquipment\n\n* Hybrid Knife (Erbe Elektromedizin GmbH)\n* VIO 3 generator + ERBEJet 2 water-jet system\n* Methylene-blue tinted saline\n* Electrosurgical settings: ENDO CUT Q 2-3-3 for mucosal incision and myotomy",[234],"Vessel Puncture Site Reaction","2026-05-08",{"date":217,"type":40},{"date":238,"type":40},"2026-02-01",{"date":240,"type":22},"2027-12-30",{"name":46,"class":47},{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":144,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":257,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},"100626914","phase-3-pancreatic-enzyme-replacement-in-acute-necrotizing-pancreatitis-100626914","NCT07441824","Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis","Effect of Pancreatic Enzyme Replacement Therapy in Patients With Acute Necrotizing Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial","PERiANP","Inclusion Criteria:\n\n* Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria\n* Index episode of acute pancreatitis with more than 50% pancreatic parenchymal necrosis and at least 5% loss of pre pancreatitis body weight at the time of screening\n* Within 6 weeks of onset of disease\n* Able to take food orally\n* Age 18-60 years\n* Both genders\n\nExclusion Criteria:\n\n* Underlying chronic pancreatitis\n* Recurrent acute pancreatitis\n* Pancreatic cancer\n* Patients being discharged with NJ tubes\n* Pregnancy and lactation\n* Inability to give informed consent.",{"count":251,"type":22},140,[25],"In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, the investigators propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). The investigators will include patients of 18-60yrs age and both genders with \\>50% pancreatic parenchymal necrosis and at least 5% loss of body weight.\n\nThe primary outcome measure is percent change in body weight at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.",[255,256],"Acute Necrotizing Pancreatitis","Pancreatic Exocrine Insufficiency",[258,259,260],"acute pancreatitis","pancrearic exocrine insufficiency","pancreatic enzyme replacement therapy","2026-04-29",{"date":263,"type":40},"2026-05-05",{"date":265,"type":40},"2026-04-10",{"date":267,"type":22},"2027-06",{"name":46,"class":47},4,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":79},"100589523","vonaprazan-versus-esomeprazole-for-healing-of-la-grade-b-or-higher-esophagitis-after-poem-100589523","NCT06955520","Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM","Inclusion Criteria:\n\n* Age ≥18 years\n* History of POEM for achalasia\n* Endoscopic confirmation of LA grade B, C, or D reflux esophagitis at 3 months post-POEM\n* GERD symptoms (heartburn, regurgitation) for ≥4 weeks\n* Willingness to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* History of prior anti-reflux surgery\n* Presence of Barrett's esophagus, esophageal stricture, or malignancy\n* Severe gastroparesis or esophageal motility disorder unrelated to achalasia\n* Pregnancy or breastfeeding\n* Severe hepatic or renal impairment (ALT\u002FAST \\>3× ULN, eGFR \\\u003C30 mL\u002Fmin)\n* Regular use of NSAIDs, steroids, or anticoagulants affecting esophageal healing",{"count":277,"type":22},300,[59],"Peroral Endoscopic Myotomy (POEM) is a well-established treatment for achalasia; however, it is frequently associated with gastroesophageal reflux disease (GERD), with many patients developing LA grade B or higher esophagitis. Proton pump inhibitors (PPIs) like Esomeprazole are the standard treatment, but Vonaprazan, a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.\n\nPrimary Objective:\n\n• To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks in patients receiving Vonaprazan 20 mg versus Esomeprazole 40 mg.\n\nSecondary Objectives\n\n* To assess improvement in reflux symptoms using the GERD-Q score at 8 weeks.\n* To evaluate the incidence of adverse events in each treatment group.",[281],"GERD","2026-04-22",{"date":284,"type":40},"2026-04-27",{"date":286,"type":40},"2025-04-30",{"date":288,"type":22},"2028-12-25",{"name":46,"class":47},{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":304,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":79},"100623670","artificial-intelligence-guided-detection-of-blood-vessels-to-enhance-safety-in-third-space-endoscopic-procedures-100623670","NCT07399652","Artificial Intelligence-Guided Detection of Blood Vessels to Enhance Safety in Third-Space Endoscopic Procedures","Artificial Intelligence-Guided Detection of Anatomical Markers to Enhance Safety in Third-Space Endoscopic Procedures","Inclusion Criteria:\n\n* Patients diagnosed with Achalasia Cardia or neoplasms.\n\nExclusion Criteria:\n\n* Patients with conditions deemed unsuitable for third space endoscopy procedures (e.g.: Candidiasis)",{"count":298,"type":22},20,[59],"This prospective study aims to evaluate the performance of a novel Artificial Intelligence (AI) clinical decision support tool during third space endoscopic procedures, such as Endoscopic Submucosal Dissection (ESD) and Peroral Endoscopic Myotomy (POEM).\n\nWhile these procedures are effective for treating gastrointestinal neoplasms and motility disorders, they carry risks of intraprocedural bleeding and perforation if submucosal blood vessels are not correctly identified and coagulated. Building on previous retrospective validation, this study will assess whether a real-time artificial intelligence model can assist endoscopists in detecting and delineating blood vessels more accurately and faster during live human procedures.",[302,303],"Achalasia Cardia","Tumor",[305,306,228,307,308,309],"Artificial Intelligence","Third Space Endoscopy","ESD","STER","EMR","2026-04-14",{"date":312,"type":40},"2026-04-15",{"date":314,"type":40},"2026-02-10",{"date":316,"type":22},"2026-04-30",{"name":46,"class":47},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":79},"100589405","a-randomized-three-arm-study-comparing-vonaprazan-10-mg-vonaprazan-20-mg-and-esomeprazole-40-mg-for-the-healing-of-la-grade-b-or-higher-reflux-esophagitis-at-8-weeks-100589405","NCT06953986","A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks","Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks","Inclusion Criteria:\n\n* Adults ≥18 years of age.\n* Endoscopically confirmed LA grade B, C, or D reflux esophagitis.\n* GERD symptoms (heartburn, regurgitation) for at least 4 weeks prior to enrollment.\n* Willing to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Previous or ongoing treatment with Vonaprazan or Esomeprazole in the last 4 weeks.\n* Prior esophageal surgery or radiation therapy.\n* Barrett's esophagus, esophageal stricture, or malignancy.\n* Pregnant or breastfeeding women.\n* History of PPI-refractory GERD or severe gastroparesis.\n* Significant hepatic or renal impairment (ALT\u002FAST \\>3× ULN, eGFR \\\u003C30 mL\u002Fmin).\n* Use of NSAIDs, steroids, or anticoagulants affecting healing.",{"count":326,"type":22},414,[59],"Primary Objective\n\n• To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks among patients treated with Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg once daily.\n\nSecondary Objectives\n\n* To assess the improvement in reflux symptoms using the GERD-Q score at 8 weeks.\n* To evaluate the incidence of adverse events across treatment groups.",[281],"2026-03-04",{"date":332,"type":40},"2026-03-06",{"date":334,"type":40},"2025-12-20",{"date":336,"type":22},"2027-12-12",{"name":46,"class":47},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":346,"targetDuration":4,"studyType":23,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":4},"100624760","a-single-centre-open-prospective-pilot-clinical-study-to-assess-the-safety-and-performance-of-the-ties-transcutaneous-implant-system-in-patients-requiring-a-permanent-ileostomy-or-colostomy-100624760","NCT07413822","A Single-centre Open, Prospective, Pilot Clinical Study to Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy","To Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy","TIES IV","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Patients requiring a permanent ileostomy or colostomy\n* Planned for stoma revision surgery with implantation of the TIES® system\n* Ability to understand the study procedures and comply with follow-up visits\n* Willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Age below 18 years or above 75 years\n* Temporary stoma or planned stoma reversal\n* Active abdominal or peristomal infection at the time of surgery\n* Severe uncontrolled systemic illness that may increase surgical risk\n* Known allergy or hypersensitivity to device materials\n* Pregnancy or lactation\n* Participation in another interventional clinical study within the last 30 days\n* Any condition which, in the opinion of the investigator, makes the patient unsuitable for the study",{"count":347,"type":22},10,[59],"This is a single-centre, prospective, open-label pilot clinical study designed to evaluate the safety and performance of the TIES® (Transcutaneous Implant Evacuation System) in adult patients requiring a permanent ileostomy or colostomy. Eligible patients will undergo surgical implantation of the TIES® Port as part of stoma revision. Participants will be followed for 16 weeks post-implantation to assess device safety, tissue ingrowth and healing, performance, durability, and impact on quality of life. Safety will be evaluated through monitoring of adverse events, while performance and usability will be assessed using structured questionnaires and clinical assessments. Quality of life will be measured using the validated Stoma-QoL questionnaire. The study aims to generate clinical evidence on the feasibility and safety of the TIES® system as an alternative to conventional stoma management.",[351,352],"Ileostomy - Stoma","Colostomy - Stoma","2026-02-13",{"date":355,"type":40},"2026-02-17",{"date":219,"type":22},{"date":358,"type":22},"2028-05-30",{"name":46,"class":47},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":88,"enrollmentInfo":366,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":79},"100621531","a-single-center-evaluation-of-ai-enabled-sureform-robotic-stapler-sureformtm-compared-to-conventional-stapler-for-colorectal-cancer-procedures-100621531","NCT07371832","A Single Center Evaluation of AI Enabled SureForm Robotic Stapler (SureformTM) Compared to Conventional Stapler for Colorectal Cancer Procedures","Inclusion Criteria:\n\nA. Subjects, 18 to 90 years B. Subjects who will undergo Planned robotic-assisted surgery or laparoscopic surgery (as the primary treatment) for non-metastatic colorectal cancer where staplers are utilized for transection and\u002For creation of anastomosis\n\nExclusion Criteria:\n\n* A. Emergency Surgery for non-metastatic colorectal cancer B. Subjects who are being treated for recurrent colorectal cancer C. Subjects who will require extensive dissection to release adhesions or with advanced cancer which may result in anastomotic leak and\u002For bleeding unrelated to the stapler D. Subjects who have perforated, obstructing or locally invasive neoplasm (T4b) E. Subjects who have major concomitant abdominal or pelvic procedures (e.g. hepatectomies, incisional ventral hernia repair, nephrectomies, hysterectomy) planned along with surgery for colorectal cancer",{"count":190,"type":22},"Robotic-assisted surgeries are especially valuable for colorectal pathologies because they offer better vision and control for surgical manipulation given the narrow operative region within the pelvis .Some of the iatrogenic risk factors associated with higher post-operative adverse events following colorectal surgeries are surgeon experience' and hospital case load'. In order to mitigate these factors, surgical staplers have gained preference amongst surgeons due to their reproducible results and ease of learning At present there are only two methods of creating an anastomosis: hand-sewn technique using sutures or surgical staplers. Surgical staplers have been shown to be as effective as hand-sewn techniques for colorectal anastomoses However, anastomotic strictures can be bothersome for patients and the rate of stricture is fourfold higher for stapled anastomoses than for those that are hand sewn in colorectal anastomoses . Additionally, overzealous or incorrect stapling could also result in hemostasis or ischemia One of the most dreaded adverse events of colorectal resection is anastomotic leakages followed, in decreasing severity, by post-operative bleeding and ileus. Because of the severity of adverse events associated with an anastomotic leak, it is important to detect it early and provide early management for the same. However, diagnosis of anastomotic leakage is commonly a symptomatic diagnosis based on development of gas, purulent or fecal discharge from the drain, purulent discharge from the rectum, pelvic abscess or peritonitis. Such severe symptoms further complicate the post-operative recovery and lengthen the hospital stay. Interestingly, it has been\n\nreported that anastomotic leaks were more often diagnosed late in the postoperative period and more often after hospital discharge, or 12 days postoperatively . Anastomotic leakage rates vary from the colon to the rectum, with much higher rates in the rectum. Because of the severity of adverse events associate with an anastomotic leak, there is a pressing need for new techniques for prevention of anastomotic leakages .",[369],"Colorectal Cancer",{"date":355,"type":40},{"date":372,"type":40},"2026-02-05",{"date":374,"type":22},"2028-02-28",{"name":46,"class":47},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":383,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":4},"100623624","efficacy-and-safety-of-esomeprazole-40-mg-iv-in-post-surgical-patients-admitted-to-the-icu-100623624","NCT07399054","Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU","Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU (EPIC-ICU)","Inclusion Criteria:\n\n* Adult patients aged 18-75 years admitted to an ICU post-surgery.\n* Non-esophagogastric post-surgical patients.\n* An anticipated ICU stay for at least 72 hours.\n* Willing to provide consent.\n\nExclusion Criteria:\n\n* Allergy to the study medications or excipients\n* Need for enteral feeding\n* Estimated survival of \\\u003C96 hours\n* Pregnant and breastfeeding females.\n* History of severe thrombocytopenia, coagulopathy, Child-Pugh Class C liver disease, or organ transplant requiring immunosuppressive therapy.\n* On other PPIs and\u002For NSAIDs for last 48 hrs.",{"count":57,"type":22},"Critically ill patients admitted to intensive care units (ICUs) are predisposed to upper gastrointestinal (GI) bleeding secondary to stress-related mucosal damage. The two most significant independent risk factors for stress ulceration and subsequent GI bleeding in this setting are mechanical ventilation and coagulopathy.1,2 Observational data indicate that proton pump inhibitors (PPIs) remain the most frequently employed prophylactic agents in the ICU.3\n\nComparative studies evaluating the efficacy of PPIs have shown a positive correlation between their pharmacokinetic properties and acid-suppressive activity. Among available PPIs, esomeprazole demonstrates superior pharmacokinetic characteristics, translating into more effective acid control in clinical use.7,8 In fact, one study reported that the area under the curve (AUC) for esomeprazole was nearly twice that of omeprazole at equivalent doses (14), supporting its enhanced acid-suppressive effect and prolonged maintenance of intragastric pH \\> 4.9",[386,387],"Stress Ulcers","Reflux Episodes",{"date":314,"type":40},{"date":390,"type":22},"2026-01-15",{"date":392,"type":22},"2027-02-28",{"name":46,"class":47},{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":79},"100616564","to-evaluate-early-2-week-vs-standard-4-week-metal-stent-removal-following-endoscopic-ultrasound-guided-won-drainage-100616564","NCT07307248","To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage","A Randomized Controlled Trial To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage.","STEP1","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients with walled-off pancreatic necrosis (WON) undergoing endoscopic ultrasound-guided drainage with lumen-apposing metal stent (LAMS)\n* Radiological resolution of the pancreatic fluid collection ≥70% at 2 weeks after index endoscopic drainage, assessed on cross-sectional imaging (CT or MRI)\n\nExclusion Criteria:\n\n* Presence of chronic pancreatitis\n* Pancreatic malignancy (suspected or confirmed)\n* Incomplete endoscopic necrosectomy or persistent large necrotic debris on imaging at 2 weeks after drainage\n* Occurrence of major procedure-related adverse events within the first 2 weeks, including:\n* Clinically significant bleeding\n* Infection requiring additional intervention\n* Stent migration\n* Inability or unwillingness to provide written informed consent",{"count":403,"type":22},408,[59],"In adults with walled-off pancreatic necrosis (WON) undergoing endoscopic ultrasound (EUS)-guided transluminal necrosectomy, does early removal of the lumen-apposing metal stent (LAMS) (at 2 weeks or immediately after the last necrosectomy) with placement of a double-pigtail plastic stent (DPT), compared to delayed LAMS removal at 4 weeks without a DPT, result in a lower rate of pancreatic fluid collection (PFC) recurrence or need for reintervention over 12 months.",[407],"Walled Off Necrosis",[409],"Early LAMS removal","2026-01-27",{"date":412,"type":40},"2026-01-28",{"date":414,"type":40},"2025-12-25",{"date":416,"type":22},"2028-12-31",{"name":46,"class":47},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":425,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":434,"leadSponsor":436,"locationsCount":4},"100618299","external-multicentre-validation-of-a-machine-learning-model-to-predict-colonic-adenoma-in-indian-adults-100618299","NCT07329816","External, Multicentre Validation of a Machine-Learning Model to Predict Colonic Adenoma in Indian Adults","External, Multicentre Validation of a Machine-Learning Model to Predict Colonic Adenoma in Indian Adults-A Prospective, Observational, Multicentre Study","Inclusion Criteria:\n\n* Adults ≥18 years undergoing diagnostic colonoscopy.\n* Adequate bowel preparation (Boston Bowel Preparation Scale total ≥6 with each segment ≥2).\n* Complete examination (cecal intubation; withdrawal time ≥6 min when no therapy).\n* Availability of all model predictors per CRF.\n\nExclusion Criteria:\n\n* • Known CRC or polyp, prior colectomy, polyposis syndromes, known IBD, or strong hereditary CRC syndromes (e.g., Lynch) if excluded in derivation.\n\n  * Inadequate prep, incomplete colonoscopy, obstructing lesions preventing optical diagnosis beyond obstruction.\n  * Emergency colonoscopies, therapeutic-only procedures without diagnostic intent.",{"count":426,"type":22},1000,"Colorectal adenomas are precursors to colorectal cancer (CRC). Accurate pre-procedure risk stratification could optimize colonoscopy yield and resource allocation in India, where adenoma prevalence varies by age, sex, and lifestyle\u002Fmetabolic factors. ML models can integrate multiple predictors to estimate individualized risk.\n\nExisting risk scores are largely Western; performance and calibration may not be appropriate in Indian populations with different socio-demographic and metabolic profiles. External, prospective, multicentre validation is essential before clinical implementation.",[429],"Colonoscopy","2026-01-09",{"date":432,"type":40},"2026-01-12",{"date":238,"type":22},{"date":435,"type":22},"2027-03-30",{"name":46,"class":47},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":452,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":461,"locationsCount":4},"100618298","pre-cut-versus-intentional-double-guidewire-for-ercp-cannulation-prospective-randomized-controlled-trial-100618298","NCT07329803","Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial","PRIDE","Inclusion Criteria:\n\n\\- Age \\> 18 years.\n\n* Valid indication for ERCP (benign or malignant obstruction).\n* Native papilla (no prior sphincterotomy).\n* Difficult Biliary Cannulation (DBC) defined by ESGE \"5-5-2\" criteria:\n* \\> 5 minutes of cannulation attempts.\n* \\> 5 contacts with the papilla.\n* \\> 1 inadvertent pancreatic duct cannulation.\n\nExclusion Criteria:\n\n* Ampullary mass or tumor preventing standard cannulation view.\n\n  * Surgically altered anatomy (e.g., Billroth II, Roux-en-Y).\n  * Uncorrectable coagulopathy (INR \\> 1.5 or Platelets \\\u003C 50,000).\n  * Acute pancreatitis present prior to ERCP.",{"count":445,"type":22},840,[59],"Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery.Precut papillotomy and Double Guidewire Technique (DGT) are both salvage techniques used in ERCP when standard biliary cannulation fails.\n\nPrecut (Needle-Knife Precut): An endoscopic incision made into the papilla to gain access to the bile duct when conventional methods fail.\n\nIntentional Double Guidewire Technique (DGT): A technique where a guidewire is intentionally placed into the pancreatic duct to act as a \"guide\" or anchor, straightening the biliary axis and allowing a second guidewire to be inserted into the bile duct.",[99,449,95,450,451],"Choledocholithiasis","Biliary Strictures Caused by Malignant Neoplasms","Biliary Stricture",[453,454,455,456],"Selective CBD cannulation","Post ERCP Pancreatitis","Precut Sphincterotomy","Double Guidewire Technique",{"date":432,"type":40},{"date":459,"type":22},"2026-01-25",{"date":392,"type":22},{"name":46,"class":47},{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":469,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":4},"100618297","indian-national-study-to-assess-incidence-and-severity-of-post-ercp-pancreatitis-after-following-sop-100618297","NCT07329790","Indian National Study to Assess Incidence and Severity of Post-ERCP Pancreatitis After Following SOP","INSPIRE","Inclusion Criteria:\n\nConsecutive ERCPs during the enrollment window.\n\n* Males and females between 18 and 75 years of age who ca comprehend instructions, follow study procedures, willing to sign an informed consent form and have a clinical indication to undergo a ERCP.\n* Patients undergoing ERCP for therapeutic indications\n* Patients with intact papilla\n\nExclusion Criteria:\n\n* patient undergoing ERCP for diagnostic indications\n* Acute pancreatitis\n* Previous sphincterotomy\n* Altered anatomy, defined as anatomical variations in which bile and\u002For pancreatic secretion donot enter the duodenum by way of the ampulla of Vater\n* Pregnancy\n* Signs of Congestive heart failure, such as pitting edema or a NYHA classification greater than class II heart failure.\n* Respiratory insufficiency (pO2 \\\u003C 60 mmHg or saturation \\\u003C 90% despite FiO2 of 30% or requiring mechanical ventilation).\n* Severe liver disease (cirrhosis and ascites)\n* Contraindication for rectal indomethacin",{"count":470,"type":22},2366,"Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery. However, despite its therapeutic efficacy, ERCP carries a significant risk of procedure-related adverse events, of which post-ERCP pancreatitis (PEP) is the most common and clinically important complication.\n\nThe reported incidence of PEP in prospective multicenter studies ranges from 7 % to 10 % in unselected populations, and may increase to 15 % or higher in high-risk subsets such as patients with difficult cannulation, sphincter of Oddi dysfunction, or a prior history of pancreatitis or PEP. Although the majority of cases are mild and self-limited, a small but important proportion (approximately 10-15 %) progress to moderate or severe disease, resulting in prolonged hospitalization, increased cost, and occasionally mortality.\n\nOver the past two decades, extensive research has improved our understanding of PEP pathogenesis and risk stratification. Several patient-related (younger age, female sex, prior PEP or pancreatitis, sphincter of Oddi dysfunction, asymptomatic choledocholithiasis) and procedure-related (difficult cannulation, pancreatic duct contrast injection or guidewire passage, pancreatic sphincterotomy, endoscopic papillary balloon dilation) predictors have been identified.",[99],{"date":432,"type":40},{"date":475,"type":22},"2026-01-10",{"date":477,"type":22},"2026-07-30",{"name":46,"class":47},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":88,"enrollmentInfo":486,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":493,"leadSponsor":495,"locationsCount":79},"100614714","prospective-comparison-of-the-carbon-footprint-of-eus-vs-mrcp-for-evaluation-of-suspected-choledocholithiasis-100614714","NCT07283185","Prospective Comparison of the Carbon Footprint of EUS vs MRCP for Evaluation of Suspected Choledocholithiasis","Prospective Comparison of the Carbon Footprint of Endoscopic Ultrasound (EUS) vs Magnetic Resonance Cholangiopancreatography (MRCP) for Evaluation of Suspected Choledocholithiasis","Inclusion Criteria:\n\n* Age ≥18 years\n* Intermediate likelihood of CBD stone (per ESGE)\n* Undergoing either MRCP or EUS for evaluation\n\nExclusion Criteria:\n\n* High or low likelihood category (per ESGE)\n* Undergoing both MRCP and EUS simultaneously\n* Contraindications to either modality",{"count":190,"type":22},"MRCP and EUS are diagnostically equivalent in detecting CBD stones among patients with intermediate risk, as shown in a landmark RCT. However, MRI-based imaging is power-intensive, requiring large infrastructure and long scan durations. EUS, a less energy-consuming and portable procedure, has the added advantage of enabling same-session ERCP, reducing the need for repeat procedures.",[449],"2026-01-04",{"date":491,"type":40},"2026-01-06",{"date":154,"type":40},{"date":494,"type":22},"2026-11",{"name":46,"class":47},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":88,"enrollmentInfo":503,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":79},"100521190","application-of-machine-learning-models-to-reduce-need-for-diagnostic-eus-or-mrcp-in-patients-with-intermediate-likelihood-of-choledocholithiasis-100521190","NCT06066372","Application of Machine Learning Models to Reduce Need for Diagnostic EUS or MRCP in Patients With Intermediate Likelihood of Choledocholithiasis","Application of Machine Learning Models to Reduce Need for Diagnostic EUS or MRCP in Patients With Intermediate Likelihood of Choledocholithiasis- A Prospective, Open Label, Diagnostic Study","Inclusion Criteria:\n\n• Individual 18 years or older with a suspected choledocholithiasis satisfying either ASGE or ESGE risk stratification criteria of intermediate likelihood undergoing EUS or MRCP\n\nExclusion Criteria:\n\n* Patients having co-exiting disease of pancreato biliary system other than gall stones and choledocholithiasis which include chronic pancreatitis, biliary stricture, pancreatobiliary malignancy, portal biliopathy\n* Patients having underlying chronic liver diseases\n* Pregnancy and breast feeding\n* Previous history of cholecystectomy",{"count":426,"type":22},"Machine learning predictive model can help in stratifying heterogenous intermediate likelihood group to reduce need for EUS or MRCP in selected subgroup of patients.",[449],{"date":491,"type":40},{"date":508,"type":40},"2023-10-01",{"date":510,"type":22},"2026-10-30",{"name":46,"class":47},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":18,"minAge":519,"maxAge":188,"enrollmentInfo":520,"targetDuration":4,"studyType":23,"phases":522,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100617934","comparison-of-conventional-and-short-submucosal-tunnel-techniques-in-type-ii-achalasia-100617934","NCT07325071","Comparison of Conventional and Short Submucosal Tunnel Techniques in Type II Achalasia","A Randomized Controlled Trial Comparing Conventional and Short Submucosal Tunnel Techniques in Type II Achalasia","Inclusion Criteria:\n\n1. Adults aged \\>18 years.\n2. Diagnosis of Type II achalasia naïve patients based on high-resolution manometry (Chicago Classification v4).\n3. Eckardt score \\>3.\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Type I or III achalasia.\n2. Previous endoscopic or surgical treatment for achalasia.\n3. Contraindications for POEM (e.g., coagulopathy, portal hypertension).\n4. Sigmoid Achalasia","19 Years",{"count":521,"type":22},636,[59],"Rationale for This Study The primary rationale for this study is to evaluate whether a shorter submucosal tunnel during POEM with an EGJ-focused myotomy in type II Achalasia cardia patients, provides equivalent or superior symptom relief compared to the conventional approach while minimizing adverse events such as GERD \\& blown out myotomy and decreasing the procedure time.\n\nObjectives\n\nPrimary Objective:\n\nTo compare the incidence of GERD (with manual review) at 3 and 12 months' post-procedure between conventional POEM and two experimental short-tunnel POEM techniques in patients with Type II achalasia.\n\nSecondary Objectives:\n\nTo evaluate\n\n1. Clinical success based on Eckardt score\n2. Operating total procedure time\n3. Use of Acid Suppressants on Follow up at 1 year\n4. Severity of Esophagitis at 3 months\n5. Intraoperative \\& Postoperative adverse events (AGREE classification),\n6. GERD-HRQL (0-18) scores 3 \\& 12 Months\n7. (Clinically relevant GORD was defined as excessive oesophageal \u002FAET associated with a GERDQ score \\>7 and\u002For with any grade of reflux oesophagitis).\n8. Duration of Hospital stay\n9. Quality of life (SF36)",[194],"2025-12-31",{"date":527,"type":40},"2026-01-08",{"date":525,"type":22},{"date":530,"type":22},"2027-07-30",{"name":46,"class":47},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":539,"enrollmentInfo":540,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":79},"100617773","incidence-of-splanchnic-venous-thrombosis-in-acute-pancreatitis-and-its-correlation-with-severity-of-pancreatitis-100617773","NCT07322978","Incidence of Splanchnic Venous Thrombosis in Acute Pancreatitis and it's Correlation With Severity of Pancreatitis","Incidence of Splanchnic Venous Thrombosis in Acute Pancreatitis and it's Correlation With Severity of Pancreatitis - a Prospective Observational Study","Inclusion Criteria:\n\n* Patients aged between 18-85 years of age.\n* Diagnosis of AP as per international consensus criteria.\n\nExclusion Criteria:\n\n* Chronic pancreatitis.\n* Established malignancy.\n* Cirrhosis of liver or established portal hypertension.\n* Pregnancy.","85 Years",{"count":541,"type":22},500,"Acute pancreatitis (AP) is a common medical condition characterized by inflammation of the pancreas, affecting a significant portion of the population. With approximately one-third of patients experiencing notable morbidity due to local or systemic complications, the severity of the disease is underscored by the presence of acute peripancreatic fluid collections, acute necrotic collections, pseudocysts, and walled-off necrosis1. Notably, vascular complications, such as splanchnic vein thrombosis, further contribute to the increased morbidity and mortality associated with acute pancreatitis2. Splanchnic vein thrombosis encompasses thromboses in the splenic (SpVT), portal (PVT), and superior mesenteric veins (SMVT), either individually or in combination3. These complications are often incidentally discovered during imaging procedures conducted to assess potential complications4. Despite most cases being asymptomatic, fatal complications, including bowel ischemia, liver failure, portal hypertension, and life-threatening bleeding, have been documented, with the risk of splanchnic vein thrombosis escalating with the severity of pancreatitis",[544],"Acute Pancreatitis","2025-12-30",{"date":547,"type":40},"2026-01-07",{"date":549,"type":40},"2025-02-27",{"date":551,"type":22},"2026-02-27",{"name":46,"class":47},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":18,"minAge":519,"maxAge":560,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":573,"locationsCount":4},"100615486","effect-of-simethicone-on-helicobacter-pylori-detection-in-routine-endoscopy-100615486","NCT07293234","Effect of Simethicone on Helicobacter Pylori Detection in Routine Endoscopy","Effect of Simethicone on Helicobacter Pylori Detection: A Paired, Randomized, Pilot Study in Routine Endoscopic Practice","Inclusion Criteria\n\n* Age ≥18 years and \\\u003C80 years\n* Rapid Urease Test (RUT) positive on endoscopic gastric biopsy\n* Ability to provide informed consent\n\nExclusion Criteria\n\n* Use of antibiotics or bismuth compounds within 4 weeks prior to enrollment\n* Use of proton pump inhibitors (PPIs) within 2 weeks prior to enrollment\n* Use of H2 receptor blockers within 72 hours prior to enrollment\n* History of previous gastric surgery\n* Current anticoagulation therapy\n* Severe thrombocytopenia (platelet count \\\u003C50,000\u002Fmm³)\n* Severe comorbidities that contraindicate the administration of sedation\n* Immunodeficiency\n* Pregnancy\n* Negative initial Rapid Urease Test (RUT)\n* Inability to provide informed consent","79 Years",{"count":562,"type":22},100,[59],"Rationale: Although simethicone improves mucosal clarity, in vitro evidence suggests that its surfactant properties may disrupt bacterial adherence or viability. These findings raise concerns that simethicone may negatively affect the sensitivity of endoscopic-based H. pylori diagnostic methods. To date, no prospective in vivo study has evaluated whether simethicone influences H. pylori detection through endoscopic sampling. This randomized paired trial is designed to address this gap in evidence and evaluate whether simethicone administration reduces diagnostic yield.\n\nHypothesis: Simethicone administration prior to upper gastrointestinal endoscopy may reduce the detection rate of H. pylori by interfering with bacterial detection and diagnostic test performance.\n\nNote on Pilot Study Design: This is a pilot study conducted to test feasibility and inform the design of a larger future trial.\n\nObjectives:\n\nTo evaluate whether oral administration of simethicone prior to endoscopy reduces the diagnostic yield of H. pylori using the rapid urease test (RUT).\n\nTo evaluate whether oral administration of simethicone impacts the detection of H. pylori by other diagnostic methods, including histology, PCR, culture, and urea breath testing performed during endoscopy.\n\nTo explore variability in detection methods and determine feasibility for a future larger trial.",[566],"H Pylori Infection","2025-12-29",{"date":569,"type":40},"2026-01-02",{"date":571,"type":22},"2026-01",{"date":494,"type":22},{"name":46,"class":47},""]