[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-cholecystitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-cholecystitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,44,74,95,128,154,184,214,244,271,298,319,338,365,389],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100645228","cholecystitis-outcomes-in-the-investigation-of-cholecystectomy-versus-eus-gbd-100645228",false,"NCT07678541","Cholecystitis Outcomes in the Investigation of Cholecystectomy Versus EUS-GBD","Recurrence of Acute Cholecystitis After EUS-Guided Gallbladder Drainage Versus Cholecystectomy in Elderly Patients: A Multicenter Randomized Controlled Trial","CHOICE","Inclusion Criteria:\n\n* Age 75 years or older.\n* Radiologically confirmed acute cholecystitis.\n* Elevated inflammatory parameters.\n* Able to provide written informed consent.\n* Able to complete follow-up questionnaires.\n\nExclusion Criteria:\n\n* Age under 75 years.\n* Considered unfit for surgery.\n* ASA physical status classification below III.\n* Unwillingness to participate in follow-up assessments.\n* Lack of written informed consent.\n* Clinical Frailty Scale score of 8 or higher.","ALL","75 Years",{"count":20,"type":21},116,"ESTIMATED","INTERVENTIONAL",[24],"NA","Acute cholecystitis is common in elderly patients and becomes more frequent with increasing age. Standard treatment is laparoscopic cholecystectomy (LCC), but operative treatment may be associated with increased risk in older patients with substantial comorbidity or reduced tolerance of general anesthesia.\n\nEndoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is a minimally invasive internal drainage procedure performed through the stomach or duodenum using endoscopic ultrasound guidance and a lumen-apposing metal stent. This approach may provide an alternative to operative treatment in selected elderly patients.\n\nThe CHOICE study (CHolecystitis Outcomes in the Investigation of Cholecystectomy versus EUS-GBD) is a multicenter randomized controlled trial comparing EUS-GBD with LCC in patients aged 75 years or older with acute cholecystitis. Participants are randomly assigned to undergo either laparoscopic removal of the gallbladder or endoscopic ultrasound-guided internal gallbladder drainage.\n\nThe objective of the study is to determine whether EUS-GBD provides clinically acceptable outcomes compared with standard operative treatment in this patient population. Participants are followed using medical record review and scheduled follow-up contacts.",[27],"Acute Cholecystitis",[29,30,27],"EUS-GBD","LCC","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2026-02-01",{"date":39,"type":21},"2036-02-27",{"name":41,"class":42},"Oulu University Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":43},"100635439","usg-guided-tapa-vs-rifb-block-for-postoperative-analgesia-in-laparoscopic-cholecystectomy-100635439","NCT07552701","USG-Guided TAPA vs RIFB Block for Postoperative Analgesia in Laparoscopic Cholecystectomy","Comparison of Ultrasonography-Guided the Postoperative Analgesic Efficacy of Perichondrial Approach Modified Thoracoabdominal Nerve Block and Recto-Intercostal Fascial Plan Block in Patients Who Underwent Laparoscopic Cholecystectomy","Inclusion Criteria:\n\n* Age 18-65 years\n* ASA physical classification I-II\n* BMI \\\u003C 35 kg\u002Fm²\n* Scheduled for elective laparoscopic cholecystectomy due to cholelithiasis\n* Able to use and understand the NRS pain scoring system\n* Able to use and understand the QoR-15 scale\n* Able to communicate in Turkish\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* BMI \\> 35 kg\u002Fm²\n* ASA physical classification III-V\n* Age \\\u003C 18 or \\> 65 years\n* Allergy to local anesthetics or study analgesics\n* Pregnancy or breastfeeding\n* Inability to use or understand the NRS pain scoring system or QoR-15 scale\n* Inability to communicate in Turkish\n* Uncontrolled anxiety disorder\n* Alcohol or drug dependency\n* Neuromuscular or peripheral nerve disease\n* High-dose opioid use within 3 days prior to surgery\n* Widespread chronic pain\n* Diabetes mellitus\n* Hepatic or renal insufficiency\n* Coagulation disorders or anticoagulant use\n* Infection at the block needle insertion site\n* Concurrent second surgical procedure alongside laparoscopic cholecystectomy\n* Previous abdominal surgery or trauma history\n* Conversion from laparoscopic to open surgery\n* Technical problems with the PCA device\n* NRS score \\> 7 for four consecutive hours despite multimodal analgesia\n* Planned postoperative non-extubation\n* Termination of surgery before completion for any reason","18 Years","65 Years",{"count":54,"type":21},70,[24],"Laparoscopic cholecystectomy (LC) can cause moderate-to-severe postoperative pain from visceral, referred shoulder, and incisional sources. Multimodal analgesia is recommended, but opioids carry significant side effects. Ultrasound-guided interfascial plane blocks offer a safe alternative. The Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) blocks T5-T12 dermatomes, while the Recto-Intercostal Fascial Plane Block (RIFPB) provides sensory blockade across the upper anterolateral abdomen. This study compares the postoperative analgesic efficacy of bilateral M-TAPA versus bilateral RIFPB in patients undergoing LC.",[58,27,59,60],"Postoperative Pain","Cholelithiasis","Postoperative Nausea and Vomiting",[62,63,64],"Laparoscopic Cholecystectomy","Transversus abdominis Plane Block","Rectus-intercostalis facial plane block","2026-04-20",{"date":67,"type":35},"2026-04-27",{"date":69,"type":35},"2025-03-16",{"date":71,"type":21},"2026-05-30",{"name":73,"class":42},"Hitit University",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":43},"100635337","diagnostic-value-of-deep-learning-based-rapid-mri-in-preoperative-evaluation-of-acute-cholecystitis-100635337","NCT07551375","Diagnostic Value of Deep Learning-Based Rapid MRI in Preoperative Evaluation of Acute Cholecystitis","Fast Abdominopelvic MRI With Deep Learning-Based Reconstruction Algorithm: Image Quality Evaluation and Application in Patients With Common Abdominal and Pelvic Diseases","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinical indication for abdominopelvic MRI examination\n* Able to understand and sign the informed consent form\n* Able to lie supine and cooperate with breath-holding\u002Frespiratory commands during MRI\n\nExclusion Criteria:\n\n* Presence of absolute contraindications to MRI (e.g., pacemaker, ferromagnetic foreign body, severe claustrophobia)\n* Inability to complete the MRI scan due to severe pain, instability, or altered mental status\n* Pregnant or breastfeeding women (unless explicitly approved by protocol)\n* Previous abdominal\u002Fpelvic surgery with contraindications to MRI sequences",{"count":82,"type":21},300,"OBSERVATIONAL","This is a single-center, prospective observational study at Peking Union Medical College Hospital. The main goal is to evaluate the image quality and clinical value of a new fast abdominopelvic MRI sequence that uses deep learning-based reconstruction.\n\nThe study will include adult patients (18 years or older) who need an MRI scan of the abdomen or pelvis as part of their routine care. These patients will receive both the standard MRI sequence and the new fast sequence, with the goal of comparing the two. The fast sequence is designed to be shorter (5-8 minutes) while maintaining or improving image quality, which can help reduce patient discomfort and motion-related artifacts.\n\nRadiologists will assess the quality of the images from both sequences. The study will also look at how well the fast sequence can detect common abdominal and pelvic diseases, such as gallstones, inflammation, and tumors. This study does not involve new drugs, invasive procedures, or changes to standard care. No additional risks to patients are expected beyond those of a standard MRI scan.",[27],"2026-04-18",{"date":88,"type":35},"2026-04-24",{"date":90,"type":35},"2024-06-01",{"date":92,"type":21},"2026-12-31",{"name":94,"class":42},"Peking Union Medical College Hospital",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":102,"targetDuration":104,"studyType":83,"phases":4,"briefSummary":105,"conditions":106,"keywords":112,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":126,"locationsCount":43},"100424911","prospective-registry-of-therapeutic-endoscopic-ultrasound-100424911","NCT04813055","Prospective Registry Of Therapeutic EndoscopiC ulTrasound","PROTECT","Inclusion Criteria:\n\n* subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease\n* subject eligible to T-EUS procedures but undergoing other non-EUS based endoscopic procedures, percutaneous or surgical procedures\n* 18 years old or older\n* able to provide an informed consent to inclusion.\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* inability or unwillingness to sign the informed consent form (ICF)\n* contra-indication for endoscopy or use of fluoroscopy",{"count":103,"type":21},510,"12 Months","This registry aims to analyze long-term outcomes of therapeutic EUS (T-EUS) procedures, as well as to describe clinical and technical variables potentially predicting clinical success or adverse events, for a better selection of ideal candidates.\n\nThe study also includes standard alternatives to T-EUS procedures for outcomes comparison.",[107,108,109,110,27,111],"Gastric Outlet Obstruction","Biliary Obstruction","Acute Pancreatic Fluid Collection","Acute Pancreatitis With Infected Necrosis","Chronic Pancreatitis",[113,114,115,116,117,118,119],"Endoscopic ultrasound","Therapeutic EUS","Interventional EUS","Biliary Drainage","Gastro-jejunostomy","Gallbladder Drainage","Endoscopy","2026-04-10",{"date":122,"type":35},"2026-04-13",{"date":124,"type":35},"2020-12-01",{"date":92,"type":21},{"name":127,"class":42},"Paolo Giorgio Arcidiacono, MD",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":43},"100507908","phase-3-eus-gbd-vs-antibiotics-for-patients-at-high-risk-for-cholecystectomy-100507908","NCT05893511","EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy","Upfront Endoscopic Ultrasound-guided Gallbladder Drainage (EUS-GBD) Versus Standard Protocol (Antibiotics First) for Mild to Moderate Acute Cholecystitis in Patients Who Are Very-high-risk for Cholecystectomy: A Randomized-controlled Trial.","Inclusion Criteria:\n\n1. Consecutive patients aged ≥ 18 years old\n2. Suffering from grade 1 or 2 acute calculous cholecystitis\\*\n3. At very high-risk for early laparoscopic cholecystectomy due to poor premorbid conditions\\*\\* or elderly patients suffering from acute cholecystitis but refused operations\n\nExclusion Criteria:\n\nPatients with the following conditions are excluded from the study:\n\n* Pregnancy\n* Patients unwilling to undergo follow-up assessments\n* Patients with suspected gangrene or perforation of the gallbladder\n* Grade III acute cholecystitis33\n* Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)\n* Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum\n* Patients with liver cirrhosis, portal hypertension and\u002For gastric varices\n* Abnormal coagulation: International normalized ratio (INR) \\> 1.5 and\u002For platelets \\\u003C 50.000\u002Fmm3\n* Previous drainage of the gallbladder\n* Patients suffering acute cholecystitis due to malignant cystic duct obstruction\n* Patients with life expectancy of less than 3 years",{"count":136,"type":21},110,[138],"PHASE3","Objectives Acute cholecystitis commonly occurs in elderly patients who are at high-risk for surgery. Whether upfront Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is advantageous over antibiotics first for mild acute cholecystitis is uncertain.\n\nHypothesis to be tested The aim is to compare EUS-GBD versus standard protocol (antibiotics first) as a definitive treatment, in very high-risk patients suffering from mild to moderate acute cholecystitis. We hypothesize that EUS-GBD can reduce the 1-year risk of recurrent acute cholecystitis.\n\nDesign and subjects This is an international randomised controlled study including consecutive patients suffering from acute cholecystitis that are very high-risk for cholecystectomy. The patients would be randomized to receive EUS-GBD or antibiotics first.\n\nInterventions: EUS-GBD versus antibiotics\n\nMain outcome measures:\n\nThe primary outcome is the rate of recurrent acute cholecystitis in 1 year. Other outcomes include technical and clinical success, post-procedural pain scores, analgesic requirements, adverse events, re-admissions, re-interventions, quality of life and cost analysis.\n\nData analysis All outcomes would be analysed according to the intention-to-treat principle. Kaplan-Meier method with the log-rank test will be used to compare differences in recurrent acute cholecystitis in 1 year. A health economic analysis will also be performed. Assuming a 17.1% difference in recurrent acute cholecystitis rates, a 2-sided P value of 0.05, a power of 80%, and a 10% dropout rate, 110 patients is required.\n\nExpected results The findings of this study can help establish the role of EUS-GBD in management of high-risk patients suffering from acute cholecystitis over antibiotics alone and Percutaneous transhepatic gallbladder drainage.",[27],[142,143,144],"acute cholecystitis","EUS-guided gallbladder drainage","antibiotics","2026-04-01",{"date":147,"type":35},"2026-04-07",{"date":149,"type":35},"2023-04-26",{"date":151,"type":21},"2027-12-31",{"name":153,"class":42},"Chinese University of Hong Kong",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":43},"100629983","acute-cholecystitis-biliary-complications---icg-100629983","NCT07481760","Acute Cholecystitis Biliary Complications - ICG","Multicenter Randomized Controlled Trial Evaluating Indocyanine Green Fluorescence to Reduce Biliary Complications in Emergency Cholecystectomy for Acute Cholecystitis","ICG-ACBC","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of acute cholecystitis according to Tokyo Guidelines (TG18) criteria.\n* Planned urgent\u002Femergency laparoscopic cholecystectomy during the index admission, as determined by the treating surgical team.\n* Ability to provide written informed consent prior to surgery.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to indocyanine green (ICG) or its excipients.\n* Pregnancy or breastfeeding.\n* Clinical situation preventing protocol implementation or informed consent (e.g., life-threatening emergency requiring immediate surgery without time for study procedures).\n* Primary open cholecystectomy planned (i.e., not intended laparoscopic approach).\n* Any condition that, in the investigator's opinion, makes participation unsafe or not feasible.",{"count":163,"type":21},296,[24],"Acute cholecystitis is a common indication for emergency laparoscopic cholecystectomy. Inflammatory changes and distorted anatomy may increase the risk of biliary complications, including bile duct injury and bile leak, which are associated with significant morbidity, reinterventions, and prolonged hospitalization. Indocyanine green (ICG) fluorescence cholangiography allows real-time visualization of the extrahepatic biliary anatomy using near-infrared imaging and has shown to improve anatomical identification during elective cholecystectomy. However, its clinical impact in the emergency setting of acute cholecystitis has not been adequately evaluated in randomized multicenter trials.\n\nThe objective of this study is to determine whether the use of ICG fluorescence cholangiography during emergency laparoscopic cholecystectomy reduces the incidence of clinically relevant biliary complications compared with standard surgery without ICG.\n\nThis is a pragmatic, multicenter, open-label randomized controlled trial including 296 adult patients with acute cholecystitis undergoing urgent laparoscopic cholecystectomy. Participants will be randomized 1:1 to surgery with or without ICG fluorescence guidance. The primary outcome is the incidence of clinically relevant biliary complications, including bile duct injury or bile leak, within 90 days after surgery.",[27,167],"Biliary Complications",[142,62,169,170,171,167,172,173],"Indocyanine Green","Fluorescence Cholangiography","Bile Duct Injury","Emergency Surgery","Near-Infrared Fluorescence Imaging","NOT_YET_RECRUITING","2026-03-14",{"date":177,"type":35},"2026-03-19",{"date":179,"type":21},"2027-01-01",{"date":181,"type":21},"2029-03-31",{"name":183,"class":42},"Hospital del Mar",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":192,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":43},"100605395","early-versus-delayed-cholecystectomy-after-percutaneous-cholecystostomy-in-moderate-and-severe-cholecystitis-escape-100605395","NCT07161960","Early Versus Delayed Cholecystectomy After Percutaneous Cholecystostomy in Moderate and Severe Cholecystitis (ESCAPE)","Early Versus Delayed Cholecystectomy After Percutaneous Drainage in Moderate and Severe Cholecystitis (ESCAPE Trial)","ESCAPE","Inclusion Criteria:\n\n* The patients are diagnosed moderate or severe from of acute cholecystitis according to Tokyo Guideline 2018.\n* PCC insertion was performed by body interventionists or surgeons.\n* Laparoscopic cholecystectomy will be performed in Maharaj Nakorn Chiang Mai Hospital, Lampang Hospital and Phrae Hospital.\n* Age equal or more than 20 years-old\n\nExclusion Criteria:\n\n* The patients that suspected CBD stone and need to undergo EUS \u002F ERCP.\n* Coincidence perihepatic abscess or liver abscess\n* The patients with active or severe underlying disease, whom specialists suggest to postpone an operation.","20 Years",{"count":194,"type":21},64,[24],"Abstract:\n\nAcute cholecystitis (AC) is typically managed according to the 2018 Tokyo Guidelines, with treatment strategies determined by the severity of the disease, patient comorbidities, and hospital capabilities. In cases of moderate AC, treatment options include antibiotics with delayed laparoscopic cholecystectomy (LC), antibiotics with early LC, or antibiotics with percutaneous cholecystostomy (PCC) followed by delayed LC. However, the Toyo Guideline 2018 suggested that there is a lack of consensus regarding the optimal timing for surgery following PCC due to insufficient scientific evidence. In practice, delayed LC is often performed approximately 6 weeks after PCC insertion.\n\nWhile PCC can serve as a treatment option before definite surgery, complications such as tube dislodgment, obstruction, and failure to ambulate are common, leading to further hospital admissions and increased comorbidities. The ESCAPE trial was conducted to evaluate the optimal timing for LC following PCC in moderate and severe forms of acute cholecystitis, with the goal of improving treatment standards and reducing complications associated with PCC retention. We hypothesize that early LC after PCC insertion will be a feasible and effective alternative.\n\nMethods:\n\nThis prospective, randomized controlled trial enrolled patients diagnosed with moderate to severe acute cholecystitis who underwent PCC. Clinical manifestations and laboratory parameters were monitored for 72 hours following PCC insertion. Patients demonstrating clinical or laboratory improvement were subsequently randomized into two groups: early LC and delayed LC.\n\n* Early LC group: Laparoscopic cholecystectomy was performed during the same hospitalization.\n* Delayed LC group: Laparoscopic cholecystectomy was performed more than 6 weeks after PCC insertion.\n\nThe primary endpoint\u002Foutcome is comprehensive complication index (CCI) from PCC and LC. Secondary endpoints include Nasaar Difficulty Scoring, length of hospital stay, rate of subtotal cholecystectomy, rate of conversion to open cholecystectomy and incidence of bile duct injury.\n\nResults and Discussion:\n\nThe results of this study will provide valuable insights into the timing of LC following PCC and may influence future treatment protocols for moderate and severe acute cholecystitis. By assessing the feasibility and safety of early LC after PCC insertion, the ESCAPE trial aims to reduce the burden of PCC-related complications and optimize patient outcomes.",[27,198,62],"Percutaneous Cholecystostomy",[200,201,202,203,204],"Acute cholecystitis","Percutaneous cholecystostomy","Laparoscopic cholecystectomy","Early LC","Delay LC","2025-09-20",{"date":207,"type":35},"2025-09-25",{"date":209,"type":35},"2025-07-01",{"date":211,"type":21},"2027-11-01",{"name":213,"class":42},"Yada Suwan",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":17,"minAge":222,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":43},"100593427","one-year-outcomes-by-index-treatment-in-elderly-patients-with-acute-cholecystitis-100593427","NCT07006298","One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis","One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis: Protocol of the International, Prospective, Observational GOLDENEYE Study","GOLDENEYE","Inclusion Criteria:\n\n* patients ≥70 years\n* diagnosed with acute cholecystitis, as per the Tokyo guidelines\n\nExclusion Criteria:\n\n* prior episodes of cholecystitis or pancreatitis\n* terminal illness\n* concurrent diagnosis of acute pancreatitis, cholangitis, bile duct disease, or digestive malignancy","70 Years",{"count":224,"type":21},376,"Background: The GOLDENEYE study is an international, multicenter, prospective observational investigation designed to compare the outcomes of various management strategies for acute cholecystitis in patients aged 70 years and older. This research is driven by the increasing prevalence of gallstones and biliary tract diseases in the elderly, alongside a recognition that the burden of comorbidity in this population may necessitate tailored treatment approaches to optimize outcomes.\n\nPatients and Methods: The primary aims of the study are to evaluate the efficacy of different treatments -supportive care, percutaneous gallbladder drainage, early or delayed cholecystectomy, and EUS-guided gallbladder drainage- on patient-centric outcomes, including one-year additional treatment modalities, hospital readmissions, outpatient encounters, quality of life, and survival rates. The study adopts a robust design incorporating propensity score matching analysis to account for the non-randomized allocation of treatment modalities, thereby minimizing selection bias and enhancing the comparability of treatment groups. Inclusion criteria are centered on patients ≥70 years diagnosed with acute cholecystitis, as per the Tokyo guidelines, while key exclusion criteria include prior episodes of cholecystitis or pancreatitis, terminal illness, and concurrent diagnosis of acute pancreatitis, cholangitis, bile duct disease, or digestive malignancy. Data collection will leverage the REDCap platform for systematic and secure data management, facilitating real-time data entry and monitoring across participating centers.\n\nDiscussion: This comprehensive approach ensures the integrity and reliability of data collected on demographics, gender, clinical outcomes, and quality of life measures. Through its innovative design and methodology, the GOLDENEYE study aims to generate evidence-based insights that will significantly influence the management of acute cholecystitis in the elderly, ultimately improving patient outcomes and healthcare practices in this growing demographic population.",[27],[228,229,230,231,232,233],"laparoscopic cholecystectomy","Conservative Treatment","drainage","Endosonography","Propensity Score","Retrospective Studies","2025-06-06",{"date":236,"type":35},"2025-06-08",{"date":238,"type":35},"2025-05-15",{"date":240,"type":21},"2027-05-15",{"name":242,"class":243},"Instituto de Investigación Sanitaria y Biomédica de Alicante","NETWORK",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100590452","conservative-versus-proactive-management-of-acute-cholecystitis-after-eus-guided-transmural-gallbladder-drainage-fugitive-trial-fugitive-100590452","NCT06967597","Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage: FUGITIVE Trial (FUGITIVE)","Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage. Multicenter Randomized Clinical Trial: FUGITIVE Trial (FUGITIVE)","FUGITIVE","Inclusion Criteria:\n\n* Patient ≥ 18 years of age\n* Confirmed acute cholecystitis diagnosed according to Tokyo 2018 criteria.\n* Patient unfit for surgery: if meets one or more of the following criteria: age ≥ 80 years, American Society of Anesthesiology (ASA) ≥ III, Charlson Comorbidity Index \\> 5 and\u002For Karnofsky \\\u003C 50, or patient unwilling to undergo surgery.\n* Gallbladder drainage by LAMS stent.\n* Informed Consent signed\n\nExclusion Criteria:\n\n* Patient refusal to participate in the study\n* Gastrointestinal surgically modified anatomy preventing endoscopic access to the gallbladder.\n* Technical failure to perform endoscopic ultrasound guided-gallbladder drainage.\n* Moderate or severe ascites.\n* Severe coagulopathy International Normalized Ratio \\>1.5 and\u002For fibrinogen \\\u003C120) or thrombocytopenia (platelets \\\u003C20,000).\n* Patient unable to tolerate sedation or general anesthesia\n* Haemodynamically unstable patient\n* Life expectancy \\\u003C6 months\n* Baseline ECOG ≥4\n* Patient with ongoing malignancy\n* Pregnancy\n* Acute pancreatitis",{"count":253,"type":21},82,[24],"Patients with gallbladder inflammation (acute cholecystitis) who cannot undergo surgery due to their fragility and surgical risk require a gallbladder drainage. It has been confirmed in previous studies that the gallbladder drainage from the digestive tract is a better alternative, because it has fewer complications than external (percutaneous) gallbladder drainage. However, there are no known studies that demonstrate whether it is better to maintain this drainage indefinitely, or to carry out periodic revisions of the drainage to progressively remove the stones lodged in the gallbladder and remove the drainage once this has been achieved. In this study we aim to compare the clinical evolution of patients who undergo this gallbladder drainage, dividing them into two groups:\n\n* One group of patients in whom we maintain a metallic prosthesis or stent, which communicates the gallbladder with the stomach, indefinitely in order to always guarantee a drainage of the bile towards the digestive tract, and thus avoid new episodes of cholecystitis.\n* Another group of patients who, one month after having undergone drainage, undergo a new procedure to remove the gallbladder lithiasis, until it is empty and without inflammation and we can remove the metal stent, leaving only a very thin plastic catheter to maintain the fistula and thus the bile continues to flow into the digestive tract. More than one procedure may be required to completely clear the gallbladder.\n\nKnowledge of whether one strategy or the other presents fewer complications in the short, medium and long term is essential to be able to offer the best alternative to our patients.\n\nThe aim of the study is to compare the clinical outcome of these patients who have a definitive drain inserted with those who undergo several procedures to clear the gallbladder until the drain is removed. The rate of complications, the need for re-interventions and hospital admissions, new episodes of acute cholecystitis, quality of life and mortality of both groups over a period of one year are compared.",[27],[143,142,258,259,260],"interventional endoscopic ultrasonography","lumen apposing metal stents","percutaneous cholecystostomy","2025-06-05",{"date":263,"type":35},"2025-06-10",{"date":265,"type":35},"2025-06-01",{"date":267,"type":21},"2027-06-01",{"name":269,"class":42},"Hospital General Universitario de Alicante",2,{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":278,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":43},"100538152","prevention-of-acute-cholecystitis-with-etgbd-100538152","NCT06287112","Prevention of Acute Cholecystitis With ETGBD","Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion","Inclusion Criteria:\n\n1. Adults 19 years of age or older\n2. Patients requiring endoscopic retrograde cholangiography and drainage for therapeutic purposes.\n3. Patients with imaging (CT, Cholangiogram) confirmed confluence of the cystic duct with the distal third of the common bile duct.\n4. Patients who have voluntary informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who have undergone percutaneous\u002Fsurgical bile duct or gallbladder drainage prior to study enrollment.\n* Patients with anatomic deformity of the upper gastrointestinal tract after gastric or hepatobiliary surgery\n* Patients with concomitant gastric\u002Fduodenal obstruction\n* Patients with confirmed or suspected cystic duct obstruction on imaging studies\n* Patients with acute cholecystitis, acute pancreatitis\n* Patients who underwent cholecystectomy\n* Patients with a life expectancy of less than 3 months\n* Patients who are otherwise unable to undergo endoscopic retrograde cholangiopancreatography","19 Years",{"count":280,"type":21},35,[24],"The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.\n\nIn this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.",[108,27],[285,286,287,288,200],"Malignant biliary obstruction","Fully covered self expandable metal stent","Endoscopic transpapillary gallbladder drainage","Preventive Effect","2025-02-18",{"date":291,"type":35},"2025-02-20",{"date":293,"type":35},"2024-06-20",{"date":295,"type":21},"2027-03-30",{"name":297,"class":42},"Seoul National University Hospital",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":43},"100579149","gallbladder-stenting-in-fc-sems-100579149","NCT06820541","Gallbladder Stenting in FC-SEMS","Prophylactic Endoscopic Transpapillary Gallbladder Drainage to Prevent Post-ERCP Cholecystitis After Covered Metal Stent Placement for Distal Biliary Obstruction: a Randomized Controlled Study","Inclusion Criteria:\n\n* Adult patients\n* Signed informed consent\n* Patients requiring covered metal stent placement for managing MBO\n* High-risk of post-endoscopic cholangiopancreatography acute cholecystitis according to the following criteria:\n* tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;\n* presence of at least 2 of the following:\n\n  1. gallbladder stones;\n  2. CBD diameter ≤ 10 mm;\n  3. intraprocedural gallbladder opacification;\n  4. cystic duct orifice at risk of being covered by the fully-covered stent\n\nExclusion Criteria:\n\n* History of cholecystectomy\n* Endoscopic retrograde cholangiopancreatography not feasible for duodenal stenosis or failed biliary cannulation\n* Patients with previous gallbladder drainage\n* Acute cholecystitis is already present based on the Tokyo guidelines",{"count":306,"type":21},80,[24],"The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis.\n\nThe main question it aims to answer is:\n\nDoes prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis.\n\nParticipants will:\n\n1. receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement\n2. will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis",[108,27],"2025-02-06",{"date":312,"type":35},"2025-02-11",{"date":314,"type":21},"2025-03-01",{"date":316,"type":21},"2026-10-01",{"name":318,"class":42},"Azienda Ospedaliera Universitaria Integrata Verona",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":222,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":334,"leadSponsor":336,"locationsCount":4},"100551379","the-outcomes-of-laparoscopic-cholecystectomy-for-acute-cholecystitis-within-and-beyond-the-first-72-hours-does-it-differ-100551379","NCT06459323","the Outcomes of Laparoscopic Cholecystectomy for Acute Cholecystitis Within and Beyond the First 72 Hours, Does it Differ?!","Inclusion Criteria:\n\n1. Patients with acute cholecystitis within and after 72 hours.\n2. Patients over 18 years.\n3. Patients with no common bile duct stones based on imaging and biochemical criteria\n4. Fit for surgery.\n\nExclusion Criteria:\n\n1. Patients not fit for surgery\n2. Patients with Pancreatitis.\n3. Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Uncontrolled Diabetes Mellitus, Chronic Pulmonary Disease, significant Cardiac Disease)",{"count":326,"type":21},20,[24],"Compare outcomes of patients undergoing early laparoscopic cholecystectomy within and after72 hours of symptoms.",[27],"2024-06-12",{"date":332,"type":35},"2024-06-14",{"date":314,"type":21},{"date":335,"type":21},"2026-05-01",{"name":337,"class":42},"Assiut University",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":346,"targetDuration":348,"studyType":83,"phases":4,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":4},"100533608","external-validation-os-the-acme-scoring-system-100533608","NCT06228027","External Validation os the ACME Scoring System","Prediction of the Mortality in Acute Calculous Cholecystitis. The ACME Project.","ACME_2","Inclusion Criteria:\n\n* Acute Calculous Cholecystitis\n\nExclusion Criteria:\n\n* Acute Cholangitis\n* Chronic Cholecystitis\n* Neoplasia\n* Acute Pancreatitis\n* Pregnant",{"count":347,"type":21},10000,"90 Days","Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is surgical treatment (ST) and the accepted mortality is \\\u003C1%, but in severe and\u002For fragile patients is higher. Despite the Tokyo Guidelines, there no consensus on who is the unfit patient for ST. A recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (ACME) and could help to develop new guidelines in ACC. The aim of this study is to perfom an external validation of the new simplified scoring system for mortality in ACC.",[27],[27,352,353,354,355,356],"Cholecystectomy","Tokyo Guidelines","Postoperative Complications","Mortality","High-risk patient","2024-03-07",{"date":359,"type":35},"2024-03-12",{"date":361,"type":21},"2025-01-01",{"date":363,"type":21},"2027-04-15",{"name":183,"class":42},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":43},"100495536","influence-of-gut-microbiome-in-gallstone-disease-100495536","NCT05732480","Influence of Gut Microbiome in Gallstone Disease","Understanding Changes in the Gut Microbiome in Patients With Gallstone Disease and Its Impact on Patient Outcomes","Inclusion Criteria:\n\n* All adults (age \\>18 years of age) patients diagnosed with gallstone disease following confirmatory imaging at an East Kent University Foundation Trust Hospital. Patients of any gender, ethnicity or socio-economic background are eligible as well as pregnant women. Patients undergoing both open and laparoscopic cholecystectomy will be included.\n\nExclusion Criteria:\n\n* Patients less than 18 years of age and patients who do not have capacity to consent to involvement in the study.",{"count":373,"type":21},75,"The goal of this prospective observational study is to explore the role of the gut microbiome in patients with gallstone disease.\n\nThe main question\\[s\\] it aims to answer are:\n\n* if there is a relationship between the gut microbiome and the development of complications associated with gallstone disease (such as pancreatitis and acute cholecystitis)\n* if there are changes in the gut microbiome following cholecystectomy and the relationship with patient outcomes.\n\nParticipants will be asked to provide stool samples at fixed time points (recruitment, pre- and post-cholecystectomy if applicable and at 6 months and 3 years. They will also be asked to provide stool samples if they represent to hospital with complications associated with their gallstone disease.",[376,377,378,27],"Gall Stone","Gall Stones, Common Bile Duct","Pancreatitis","2024-02-22",{"date":381,"type":35},"2024-02-23",{"date":383,"type":35},"2023-05-30",{"date":385,"type":21},"2026-11-13",{"name":387,"class":388},"East Kent Hospitals University NHS Foundation Trust","OTHER_GOV",{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":396,"targetDuration":397,"studyType":83,"phases":4,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":43},"100335153","web-based-international-register-of-emergency-surgery-and-trauma-100335153","NCT03643718","Web-based International Register of Emergency Surgery and Trauma","WIRES-T","Inclusion Criteria:\n\n* Patients affected by an acute surgical disease\n* Patients with indication to be referred to the emergency surgeon attention\n* Patients to be operated or to be treated with non-operative approach without surgical intervention\n\nExclusion Criteria:\n\n* Patients not affected by an acute surgical disease\n* Patients without indication to be referred to the emergency surgeon attention",{"count":347,"type":21},"2 Weeks","The WIRES-T project (Web-based International Registry of Emergency General Surgery and Trauma) has been set up to allow to all the EGS (Emergency General Surgery) and Trauma surgeons to register their activity and to obtain a worldwide register of traumatic and non traumatic surgical emergencies. This will give the opportunity to evaluate results on a macro-data basis and to give index allowing stratifying, evaluating and improving the outcomes.",[400,27,401,402,403,404,405,406,407,408,409,410,411,412,413],"Acute Appendicitis","Acute Diverticulitis","Post-operative Complications","Acute Pancreatitis","Perforated Gastro-duodenal Ulcers","Adhesive Small Bowell Occlusion","Colonic Neoplastic Emergencies","Gynecological Emergencies","Vascular Emergencies","Intestinal Ischemia","Abdominal Wall Hernia","Foreign Bodies","Caustic Ingestion","Trauma","2020-07-10",{"date":416,"type":35},"2020-07-14",{"date":418,"type":21},"2020-07",{"date":420,"type":21},"2030-09",{"name":422,"class":42},"A.O. Ospedale Papa Giovanni XXIII"]