[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-fistula\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-fistula":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,48,66,100,126,147,175,202,223,250,275,297,318],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100594635","predictive-risk-factors-for-pancreatic-fistula-after-pancreaticoduodenectomy-100594635",false,"NCT07022015","Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy","Predictive Risk Factors for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Malignancy.","POPF","Inclusion Criteria:\n\n* Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.\n* Patients meeting the curative treatment intent in accordance with clinical guidelines:\n\n  * No evidence of metastasis.\n  * Radiological non-involvement of superior mesenteric vein \\& portal vein.\n* American Society of Anesthesiologists (ASA) scores I \\& II.\n* Patients aged \\> 18 years.\n* Ability to understand and the willingness to sign a written informed consent document\n* Agreement to complete the study\n\nExclusion Criteria:\n\n* Unfit patients for surgery due to severe medical illness.\n* Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.\n* Irresectable tumors in diagnostic laparoscopy.\n* History of other malignant disease.\n* Pregnant or breast-feeding women.\n* Patients with serious mental disorders.\n* Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team according to abdominal imaging data.\n* Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis\n* Patients refused to participate in the study.","ALL","18 Years","75 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD. The total number of 100 participants expected to be included in this research who underwent PD between 2025 and 2026.",[28,29,30,31,32,33,34],"Pancreas Cancer","Pancreas Neoplasm","Pancreatic Fistula","Pancreas Adenocarcinoma","Periampullary Cancer","Periampullary Carcinoma","Resectable Pancreatic Cancer","RECRUITING","2026-06-27",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2025-06-20",{"date":43,"type":22},"2026-10-20",{"name":45,"class":46},"Minia University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":47},"100573225","external-pancreatic-stent-in-pancreaticojejunostomy-100573225","NCT06743516","External Pancreatic Stent in Pancreaticojejunostomy","The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas","Inclusion Criteria:\n\n* Patients undergoing pancreaticoduodenectomy (Whipple procedure) for various indications (e.g., pancreatic cancer, ampullary cancer, etc.).\n* Patients with a confirmed soft pancreas texture, as determined intraoperatively by the surgeon.\n\nExclusion Criteria:\n\n* Patients with a hard or fibrotic pancreas, as determined intraoperatively by the surgeon.\n* Patients with severe uncontrolled comorbidities (e.g., uncontrolled diabetes, severe cardiovascular disease, renal failure).\n* Pregnancy or lactation.",{"count":21,"type":22},[25],"Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.",[30],{"date":60,"type":39},"2026-06-30",{"date":62,"type":39},"2025-01-01",{"date":64,"type":22},"2026-09-01",{"name":45,"class":46},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100604084","immunoparalysis-after-pancreaticoduodenectomy-100604084","NCT07144917","Immunoparalysis After Pancreaticoduodenectomy","Immunoparalysis After Pancreaticoduodenectomy : a Pilot Multicentric Prospective Study Based on mHLA-DR Expression","ImPaHLA","Inclusion Criteria:\n\n* Any patient undergoing a Pancreaticoduodenectomy in one of the four participating centers for a benign or malignant tumor of the pancreatic head\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnant, postpartum, or breastfeeding women\n* Indication other than tumor-related (e.g., chronic pancreatitis)\n* Patient with an infectious syndrome at the time of inclusion\n* Preoperative immunosuppression\n* Immunosuppressive disease other than cancer:\n\n  * Congenital or acquired immune deficiency\n  * Functional hyposplenism or asplenia, patient under long-term antibiotic prophylaxis for this reason\n  * Patient with HIV (and CD4 \\\u003C cells\u002Fmm³)\n  * Aplasia defined by circulating neutrophil count \\\u003C 500 cells\u002Fmm³\n  * Immunosuppressive treatment other than chemotherapy : Biotherapy, Corticosteroid therapy \\>10 mg\u002Fday or cumulative dose \\>700 mg prednisolone equivalent : Patient expected to receive immunosuppressive treatment within the first 7 postoperative days\n* Individuals deprived of liberty by judicial or administrative decisio\n* Adults under legal protection (guardianship or curatorship)\n* Individuals not affiliated with a social security scheme or an equivalent coverage\n* Refusal to participate in the study",{"count":21,"type":22},"OBSERVATIONAL","By 2030, pancreatic adenocarcinoma could become the second leading cause of cancer-related death in France. To date, Pancreaticoduodenectomy (PD) is the standard treatment for resectable adenocarcinoma of the pancreatic head. Despite advances in perioperative care, morbidity remains high, and the occurrence of postoperative complications can negatively impact patient's oncologic prognosis.\n\nSepsis is the leading cause of postoperative death following PD and it remains mainly associated with the development of a clinically-relevant postoperative pancreatic fistula (CR-POPF). More recently, post-pancreatectomy acute pancreatitis (PPAP) has been defined as a very early complication after pancreatic resection. PPAP is an ischemic and inflammatory condition of the pancreatic remnant that may be responsible for nearly half of CR-POPFs. CR-PPAP can lead to sepsis with multiorgan failure and necrotizing pancreatitis, which are with CR-POPF the two main indications for reoperation and completion pancreatectomy.\n\nDespite the major impact of severe pancreatic complications on mortality after PD, no reliable early biomarker currently exists to predict their occurence.\n\nImmunoparalysis refers to the functional impairment of immune cells with monocytes showing altered capacity of cell presentation. In classical models of inflammation such as acute pancreatitis, sepsis and surgery, the initial systemic inflammatory response syndrome is simultaneously accompanied by a compensatory anti-inflammatory reaction, which may lead to immunoparalysis. mHLA-DR (Human Leukocyte Antigen-DR on Monocytes) is considered as the most appropriate biomarker to assess this immune dysfonction. Various studies emphasize the predictive value of mHLA-DR for early detection of adverse outcomes : in acute pancreatitis, mHLA-DR predicts the onset of severe forms as early as admission and after colorectal surgery, mHLA-DR enables earlier detection of anastomotic leakage compared to conventional biomarkers.\n\nThe main hypothesis is that the severity of postoperative complications is driven by immunological factors. On one hand, this study seeks to improve the understanding of the relationship between the immune response after PD and the occurrence of pancreatic complications. On the other hand, it aims to assess if mHLA-DR could represent an early biomarker for detecting severe pancreatic complications.\n\nTherefore, the main objective of this study is to evaluate the association of mHLA-DR expression in the early postoperative period following PD and the occurrence of severe pancreatic complications",[78,79,30],"Pancreatic Ductal Adenocarcinoma (mPDAC)","Pancreatic Head Tumour",[81,82,83,84,85,86,87,88,89],"Pancreaticoduocenectomy","Pancreatic fistula","Post-Operative Pancreatic Fistula","Post-Pancreatectomy Acute Pancreatitis","Pancreatic complications","Sepsis","mHLA-DR","Immunparalysis","Immunosuppression","2026-03-25",{"date":92,"type":39},"2026-03-30",{"date":94,"type":39},"2026-03-18",{"date":96,"type":22},"2027-06-18",{"name":98,"class":46},"Hospices Civils de Lyon",4,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100629831","phase-3-octreotide-microspheres-for-preventing-pancreatic-fistula-100629831","NCT07479784","Octreotide Microspheres for Preventing Pancreatic Fistula","A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of Octreotide Microspheres for Preventing Pancreatic Fistula After Distal Pancreatectomy","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study and sign the informed consent form;\n* Age ≥18 and ≤80 years old, both males and females are eligible;\n* Preoperative imaging assessment indicates the corresponding disease is surgically resectable;\n* Planned to undergo distal pancreatectomy;\n* Female subjects of childbearing potential must agree to use reliable methods of contraception from the time of signing the informed consent form until at least 120 days after administration of the study drug. A negative HCG test result within 7 days prior to initiating study treatment is required, and they must not be lactating;\n* Male subjects with partners of childbearing potential must agree to use reliable methods of contraception from the time of signing the informed consent form until at least 120 days after administration of the study drug; during the same period, male patients must also agree not to donate sperm.\n\nExclusion Criteria:\n\n* Cirrhosis or chronic active hepatitis;\n* Presence of malabsorption syndrome, short bowel syndrome, or choleretic diarrhea that cannot be effectively controlled;\n* Acute cholecystitis;\n* Uncontrolled infection, or history of immunodeficiency, including a positive HIV test;\n* International Normalized Ratio (INR) \\>1.5, or use of medication affecting prothrombin time (PT) or activated partial thromboplastin time (APTT);\n* Patients scheduled for total pancreatectomy;\n* History of pancreatic resection surgery;\n* Concurrent severe cardiac, pulmonary, hepatic, or renal disease making the patient unfit for surgery;\n* Previous treatment with long-acting somatostatin analogues; treatment with somatostatin or short-acting somatostatin analogues within 5 half-lives;\n* Known allergy to somatostatin or its analogues;\n* Current participation in another clinical trial, except for observational, non-interventional studies or the follow-up period of an interventional study;\n* Any condition that, in the investigator's judgment, may pose a risk to the subject from receiving the study drug, or may interfere with the evaluation of the study drug, subject safety, or interpretation of study results.","80 Years",{"count":109,"type":22},230,[111],"PHASE3","This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of octreotide microspheres in preventing pancreatic fistula after distal pancreatectomy.",[30],[30,115,116],"Octreotide Microspheres","Distal Pancreatectomy","NOT_YET_RECRUITING","2026-03-15",{"date":94,"type":39},{"date":121,"type":22},"2026-04-01",{"date":123,"type":22},"2028-12-31",{"name":125,"class":46},"Shanghai Zhongshan Hospital",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":47},"100574191","phase-2-reinforced-pancreaticojejunostomy-with-or-without-glubran2-100574191","NCT06756074","Reinforced Pancreaticojejunostomy With or Without glubran2","Impact of Reinforced Pancreaticojejunostomy With or Without Tissue Adhesive Glue Modified Cyanoacrylate (Glubran 2) Following Pancreaticoduodenectomy, Randomized Controlled Clinical Trial.","Inclusion Criteria:\n\n* All the patients undergoing pancreaticoduodenectomy for cancer\n* Patients able to give their informed consent\n\nExclusion Criteria:\n\n* Unfit patients for surgery due to severe medical illness.\n* Inoperable patients by imaging studies, irresectable tumors after laparotomy or diagnostic laparoscopy.\n* Presence of distant metastasis .\n* Patients refused to participate in the study.",{"count":21,"type":22},[135],"PHASE2","Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend different techniques in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula by enforce pancreaticojejunostomy with tissue glue .",[30,28,33,138],"Pancreatic Ductal Adenocarcinoma","2026-03-13",{"date":141,"type":39},"2026-03-16",{"date":143,"type":39},"2025-01-15",{"date":145,"type":22},"2026-05-15",{"name":45,"class":46},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":155,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":47},"100621466","phase-2-prevention-of-postoperative-pancreatic-fistula-following-pancreaticoduodenectomy-by-preoperative-radiotherapy--a-phase-2-trial-100621466","NCT07370987","Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy : a Phase 2 Trial","Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy: a Phase 2 Trial","PreFiR","Inclusion Criteria:\n\n* Aged ≥ 45 years old\n* Candidate for pancreaticoduodenectomy by laparotomy\n* Body mass index (BMI) ≥ 25kg\u002Fm2\n* Diameter of main pancreatic duct (MPD) \\\u003C 3 mm on preoperative CT scan or MRI at the isthmus of the pancreas (future pancreatic section area)\n* Affiliation to a social security system (AME excepted)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Surgery indication : Chronic pancreatitis\n* Surgery indication : Pancreatic ductal adenocarcinoma\n* History of syndromic or hereditary pancreatic tumor\n* Contraindication to pancreaticoduodenectomy\n* Planned multivisceral resection involving organs or parts of organs not normally involved in pancreatico-duodenectomy\n* Planned external drainage of the main pancreatic duct at the end of the surgery\n* Neoadjuvant treatment planned or performed by chemotherapy or radiotherapy\n* History of chronic hepatitis (F3) or cirrhosis (F4)\n* Contraindication to radiotherapy\n* Previous history of abdominal radiotherapy\n* Extended pancreatic resection on the left beyond the radiotherapy area (left of the pancreatic isthmus)\n* History of complicated peptic ulcer\n* Patient treated for less than 4 weeks for an ulcer\n* History of pancreatic surgery\n* Ongoing pregnancy (confirmed by a test beta-HCG) or breast feeding or absence of birth control\n* Patients with a active pathology or history that may interfere with the study in progress or the interpretation of its results according to the investigator\n* Patients with a history or suspicion of non-compliance with medical regimens or will be unable to complete the entire study\n* Treatment with systemic corticosteroids (excluding inhaled corticosteroids)\n* Participation in another interventional clinical study (RIPH1, clinical investigation or clinical trial) or exclusion period set after the study\n* Protected persons under legal guardianship or conservatorship","45 Years",{"count":157,"type":22},50,[135],"Design of the study Prospective, single arm, multicentric, phase II open trial Number of participating sites 14 French centers of HPB Surgery departments associated with 14 Radiation Oncology Departments.\n\nImplementation of the study A screening of eligible patients will be made locally by the referring surgeon of each centre based on patient medical records.\n\n* Inclusion visit at the first surgical consultation (W-3 to D1) (V0) The inclusion visit will be done by the surgeon within 3 weeks before the first radiation oncologist visit\n* D1 (V1): first radiation oncologist visit\n* W2 (+\u002F- 3D) and W4 (+\u002F- 3D) (V2 et V3): Preoperative simulation process and treatment delivery\n* A first visit at W+2 (+\u002F- 3 D) will be mandatory to validate the positioning of the target volume by CBCT with IV constrast or MRI\n* Then to start of the administration of radiotherapy at W+4 (+\u002F- 3 D): Radiotherapy with 20 Gy, in 2 fraction of 10Gy with a one-day gap, so over a total period of 3\n\nW9 ( +\u002F- 1W) (V4): post-radiotherapy follow-up\n\n\\- Preoperative visit Day-1 before PD (V5)\n\nW10 (+\u002F- 1W) (V6):\n\n* Pancreaticoduodenectomy and post operative hospitalisation W14 (+\u002F- 1W) (V7): follow up with surgeon (30 days after pancreaticoduodenectomy)\n* W22 (+\u002F-1W) (V8): follow up with surgeon (90 days after pancreaticoduodenectomy)\n* W34 (+\u002F-1W) (V9): Last study visit (radiation oncologist) (6 months after pancreaticoduodenectomy) Medical follow-up by radiation oncologist at 6 months after surgery to assess the occurrence of potential late toxicities due to radiotherapy",[30,161],"Pancreaticoduodenectomy",[82,163,164,165],"Surgery","pancreaticoduodenectomy","Radiotherapy","2026-01-22",{"date":168,"type":39},"2026-01-27",{"date":170,"type":22},"2026-02",{"date":172,"type":22},"2027-11",{"name":174,"class":46},"Assistance Publique - Hôpitaux de Paris",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":183,"targetDuration":184,"studyType":75,"phases":4,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":199,"leadSponsor":201,"locationsCount":47},"100603647","preoperative-eus-elastography-for-pancreatic-texture-and-popf-prediction-after-pd-100603647","NCT07139236","Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD","Preoperative Endoscopic Ultrasound Elastography for Prediction of Intraoperative Pancreatic Texture and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Study","EUS-E","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Patients scheduled for elective pancreaticoduodenectomy (PD) due to pancreatic head or periampullary disease, including but not limited to:\n\n  * Pancreatic cancer (all stages eligible if resectable)\n  * Periampullary cancer\n  * Bile duct cancer\n  * Duodenal cancer\n* Patients deemed suitable for PD by the multidisciplinary pancreatic surgery team based on preoperative imaging and clinical evaluation.\n* Adequate organ function and physiological reserve to undergo major abdominal surgery, as determined by clinical assessment and anesthesiology evaluation.\n\n  * Ability to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Evidence of distant metastases or locally advanced unresectable disease on preoperative imaging or clinical evaluation (e.g., liver metastases, peritoneal carcinomatosis, involvement of major vessels beyond resectability).\n* Previous pancreatic surgery or total pancreatectomy.\n* Chronic pancreatitis confirmed by clinical, radiological, or histological criteria that could confound pancreatic stiffness assessment.\n* Severe comorbidities or American Society of Anesthesiologists (ASA) physical status classification IV or higher, making the patient unfit for surgery.\n* Preoperative serum albumin less than 2.5 g\u002FdL, indicating severe malnutrition.\n* Patients undergoing neoadjuvant chemotherapy or radiotherapy prior to surgery.\n* Pregnancy or lactation.\n* Contraindications to EUS (e.g., esophageal obstruction)",{"count":21,"type":22},"1 Year","This prospective study evaluates whether preoperative endoscopic ultrasound elastography (EUS-E) can predict pancreatic texture during surgery and risk of postoperative pancreatic fistula (POPF) in 100 patients undergoing pancreaticoduodenectomy. EUS-E measures pancreatic stiffness preoperatively. Intraoperative texture (\"soft\" or \"hard\") is assessed by surgeons blinded to EUS-E results. POPF is graded using ISGPF criteria. Predictive accuracy of EUS-E will be analyzed statistically.",[187,30],"Pancreatic Neoplasms",[189,190,191,181,192,193,194],"Pancreatic cancer","EUS","Whipple procedure","Pancreatic surgery","Pancreas","Elastography","2025-09-01",{"date":197,"type":39},"2025-09-03",{"date":195,"type":39},{"date":200,"type":22},"2026-10-01",{"name":45,"class":46},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":222,"locationsCount":47},"100593644","laparoscopic-pancreaticoduodenectomy-100593644","NCT07009119","Laparoscopic Pancreaticoduodenectomy","Feasibility, Safety and Short-term Oncosurgical Outcome of Laparoscopic Pancreaticoduodenectomy for Malignancy: A Single Centre Experience","LPD","Inclusion Criteria:\n\n* Patients meeting the curative treatment intent in accordance with clinical guidelines:\n\n  * No evidence of metastasis.\n  * Radiological non-involvement of superior mesenteric vein \\& portal vein.\n  * Preserved fat planes between celiac axis, hepatic artery \\& superior mesenteric artery.\n* Patients presenting with resectable pancreatic head cancer, cholangiocarcinoma, duodenal cancer and ampullary tumours who are fit for laparoscopic pancreaticoduodenectomy.\n\nExclusion Criteria:\n\n* Unfit patients for surgery due to severe medical illness.\n* Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.\n* Irresectable tumors in diagnostic laparoscopy.\n* Patients requiring left, central or total pancreatectomy or other palliative surgery.\n* History of other malignant disease.\n* Pregnant or breast-feeding women.\n* Patients with serious mental disorders.\n* Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team team according to abdominal imaging data.\n* Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis\n* Patients with cirrhotic liver.\n* Patients refused to participate in the study.",{"count":211,"type":22},30,[25],"Laparoscopic pancreaticoduodenectomy was first performed by Garner and Pomp in 1994. This is a technically difficult, time consuming and high rate of complication procedure. The reason is that duodenum and head of pancreas locate deeply in retroperitoneum and are surrounded by important structures such as inferior vena cava, abdominal aorta, superior mesenteric artery, superior mesenteric vein (SMV), portal vein (PV) and hepatic arteries. Injuring these structures during the surgery can lead to life-threatening complications. Moreover, doing anastomoses through laparoscopy, especially pancreatic anastomosis, is more difficult and takes more time than through open approach. The outcome of PD has improved over the last two decades due to advances in surgical techniques, anesthesia and perioperative care. Although studies from high volume centers demonstrate reduce in the operative mortality to less than 3%, the postoperative morbidity rate is still ranging from 30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive alternative to traditional interventions for pancreatic resection. Laparoscopic pancreaticoduodenectomy (LPD) is a difficult procedure that has become increasingly popular. Nevertheless, comparative data on outcomes remain limited. In this prospective study, investigators evaluate the safety and feasibility of surgical and oncological outcomes of minimally invasive PD.",[215,30,32],"Pancreatic Cancer","2025-08-22",{"date":218,"type":39},"2025-08-29",{"date":220,"type":39},"2025-06-01",{"date":38,"type":22},{"name":45,"class":46},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":233,"conditions":234,"keywords":237,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":47},"100537848","metabolomic-and-immune-profiling-in-the-development-of-pancreatic-fistulas-after-cephalic-duodenopancreatectomy-100537848","NCT06283160","METabolomic and Immune PROfiling in the Development of Pancreatic Fistulas After cepHalic duodEnopancreatectomy","Interest of Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Duodenopancreatectomy","PROMETHEE","Inclusion Criteria:\n\n* patients scheduled to undergo elective pancreaticoduodenectomy\n* Non-opposition of the subject to participate in the study.\n* Affiliated to the French social security system (CMU included).\n\nExclusion Criteria:\n\n* Emergent surgery.\n* Pregnant patients.\n* Refusal to participate or inability to provide informed consent.\n* Patient under legal protection (individuals under guardianship by court order).",{"count":232,"type":22},80,"Pancreatoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.\n\nThe aim of this prospective monocentric and observational study is to identify predictive biomarkers and\u002For risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.\n\nParticipants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling).",[30,235,236],"Acute Pancreatitis","Pancreatoduodenectomy",[238,239,82,240],"Metabolomics","Immune response","pancreatoduodenectomy","2024-10-10",{"date":243,"type":39},"2024-10-15",{"date":245,"type":39},"2024-03-01",{"date":247,"type":22},"2026-05-30",{"name":249,"class":46},"Centre Hospitalier Universitaire de Besancon",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":47},"100531330","indocyanine-green-fluorescence-in-evaluation-of-pancreatic-remnant-perfusion-100531330","NCT06198400","Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.","Indocyanine Green Fluorescence in Evaluation of Post-resection Pancreatic Remnant Perfusion After Pancreaticoduodenectomy","Inclusion Criteria:\n\n* All consecutive patients undergoing open pancreaticoduodenectomy at our department in the selected period\n\nExclusion Criteria:\n\n* Allergy to indocyanine green\n* Refusal by the patient\n* Mini-invasive procedure.",{"count":258,"type":22},60,[25],"Main goal of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of indocyanine green fluorescence. If the hypothesis will be proven, evaluation of perfusion of the pancreatic remnant with indocyanine green could be used to estimate the increased risk of the development of pancreatic fistula.",[30],[192,263,264,189,265],"ICG","Minimal invasive surgery,","Pancreatic perfusion","2024-08-19",{"date":268,"type":39},"2024-08-21",{"date":270,"type":39},"2024-05-01",{"date":272,"type":22},"2027-07-01",{"name":274,"class":46},"Charles University, Czech Republic",{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":47},"100489764","peritoneal-lavage-on-the-incidence-of-pancreatic-fistula-and-related-complications-after-pancreatoduodenectomy-100489764","NCT05657366","Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy","The Effect of Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy in Patients With Different Pancreatic Fistula Risk Scores","Inclusion Criteria:\n\n1. Preoperative diagnosis was pancreatic head, lower common bile duct, ampulla and duodenum tumors;\n2. Patients with resectable tumors evaluated by imaging examination, and patients who plan to undergo pancreatoduodenectomy;\n3. Subjects informed consent, understood and were willing to cooperate with the trial protocol, and signed relevant documents.\n\nExclusion Criteria:\n\n1. Complicated with severe liver, kidney, heart, brain, lung and other organ complications;\n2. Intraoperative changes in surgical methods, such as patients with tumor dissemination and only abdominal opening and closing; Or it needs to be resected in combination with other organs;\n3. Patients and their families do not understand the treatment implementation plan of this study;\n4. Failure to complete follow-up;",{"count":283,"type":22},260,[25],"As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Some clinicians believe that routine flushing after pancreatoduodenectomy wastes medical resources and has a negative impact on patients' comfort.\n\nIn this study, the investigators designed a multicenter prospective controlled trial to compare the effects of peritoneal lavage and natural drainage on the incidence of pancreatic fistula and related complications after pancreatoduodenectomy. To study the indications of peritoneal lavage.",[30,287],"Pancreaticoduodenal; Fistula","2023-04-20",{"date":290,"type":39},"2023-04-21",{"date":292,"type":22},"2023-05-01",{"date":294,"type":22},"2027-06-30",{"name":296,"class":46},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":315,"leadSponsor":317,"locationsCount":47},"100495008","a-multicenter-randomized-controlled-study-of-external-pancreatic-duct-stents-in-pancreaticoduodenectomy-100495008","NCT05725590","A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy","Inclusion Criteria:\n\n* Pancreatoduodenectomy with pancreaticojejunal mucosa anastomosis was performed;\n\n  * The patient has no combined organic diseases in the heart, lungs, or kidneys;\n\n    * No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors; ④ The risk score of the pancreatic fistula of the patient according to the definition of the updated Alternative Fistula Risk Score (ua-FRS). Patients with a ua-FRS score higher than 5% were included in this study.\n\nExclusion Criteria:\n\n* Previous history of other tumors or upper abdominal surgery; ② Multiple lesions and distant metastasis;\n\n  * Patients with organic diseases of important organs such as the heart, lung, and kidney, who cannot tolerate surgery, or patients who are more than 75 years old or less than 18 years old; ④ Other measures were performed to prevent pancreatic fistula, such as fibrin glue sealing, which may affect the accuracy of this study.",{"count":304,"type":22},300,[25],"The prognostic value of external vs internal pancreatic duct stents after pancreaticoduodenectomy remains controversial. This study aimed to evaluate the benefits of external and internal stents using the Updated Alternative Fistula Risk Score in both high-risk and low-risk patients with regard to the incidence of clinically relevant postoperative pancreatic fistula.",[30],[309,310,161],"Clinically relevant postoperative pancreatic fistula","External pancreatic duct stent","2023-02-02",{"date":313,"type":39},"2023-02-13",{"date":311,"type":39},{"date":316,"type":22},"2026-08",{"name":296,"class":46},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":325,"targetDuration":327,"studyType":75,"phases":4,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":47},"100451236","prognostic-factors-in-periampullary-tumors-and-cysts-100451236","NCT05155878","Prognostic Factors in Periampullary Tumors and Cysts","Prognostic Factors, Operative Care and Short and Long Term Outcomes for Cysts and Tumors in Pancreas and the Periampullary Region","Inclusion Criteria:\n\n* Recommended surgery for tumor or cyst in the pancreas or periampullary region\n* Information avalible in electronic journal files\n* Informed consent (or deceased for retrospective part of the study)\n\nExclusion Criteria:\n\n* No informed consent (and still alive at study initiation)",{"count":326,"type":22},500,"10 Years","The project aims at analysing prognostic and predictive factors involved in diagnostics and surgical treatment of cysts and tumors in the pancreas and periampullary region using both clinical data and blood and tissue samples for biomarker development and validation.",[28,29,330,30,331,332,32,163,333],"Pancreas Cyst","Pancreas Disease","Bile Duct Cancer","Surgery--Complications","2021-12-13",{"date":336,"type":39},"2022-01-05",{"date":338,"type":39},"2021-09-01",{"date":340,"type":22},"2040-01-01",{"name":342,"class":46},"Umeå University"]