[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postoperative-pancreatic-fistula\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postoperative-pancreatic-fistula":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,75,95,124],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100504099","phase-3-pancreatic-head-resection-or-total-pancreatectomy-with-islet-autotransplantation-in-patients-with-periampullary-cancer-and-high-risk-profile-for-the-development-of-postoperative-pancreatic-fistula-100504099",false,"NCT05843877","Pancreatic Head Resection or Total Pancreatectomy With Islet Autotransplantation in Patients With Periampullary Cancer and High Risk Profile for the Development of Postoperative Pancreatic Fistula","Pancreatic Head Resection or Total Pancreatectomy With Islet Autotransplantation (IAtx) in Patients With Periampullary Cancer and High Risk Profile for the Development of Postoperative Pancreatic Fistula (POPF)","XandTX","Inclusion Criteria:\n\n* suspected or confirmed periampullary carcinoma (tumor) and indication for PPPD (pylorus-preserving pancreaticoduodenectomy) or Whipple surgery\n* high-risk profile for the development of a postoperative pancreatic fistula (POPF) after pancreatic head resection: soft pancreas and Pancreatic duct diameter \\\u003C 3 mm (preoperative and intraoperative confirmation)\n* written informed consent of the participant after successful Informed consent\n\nExclusion Criteria:\n\n* patients on whom another procedure is to be performed simultaneously in addition to PPPD or Whipple surgery\n* confirmed other primary tumor\n* previous transplantation of an organ or tissue\n* known infection with HIV (HIV antibodies)\n* positive hepatitis C antibodies, positive hepatitis B surface antigens and hepatitis Bc antibodies\n* insulin-treated diabetes mellitus\n* history of hypersensitivity to any of the drugs used or their ingredients or to drugs with a similar chemical structure\n* concurrent participation in another clinical trial (incl. within the last 4 weeks prior to inclusion).\n* addiction or other medical conditions that do not allow the subject to understand the nature and not be able to appreciate the nature, scope and possible consequences of the trial\n* pregnant or breastfeeding women\n* women of childbearing age, except for women who meet the following criteria:\n\n  1. Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH \\> 40 U\u002Fml)\n  2. Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy)\n  3. Regular and correct use of a contraceptive method with an failure rate \\\u003C 1% per year\n  4. Sexual abstinence\n  5. Vasectomy of the partner\n* evidence that the patient is unlikely to comply with the protocol","ALL","18 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary objective of this clinical trial is to evaluate whether primary total pancreatectomy with simultaneous islet autotransplantation compared with pancreatic head resection (alone) can reduce perioperative morbidity and time to initiation of adjuvant therapy in patients with a high-risk constellation for pancreatic fistulas.",[27,28],"Periampullary Cancer","Postoperative Pancreatic Fistula","RECRUITING","2026-01-28",{"date":32,"type":33},"2026-01-30","ACTUAL",{"date":35,"type":33},"2025-01-28",{"date":37,"type":21},"2028-01",{"name":39,"class":40},"Technische Universität Dresden","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":41},"100610663","phase-2-pancreatic-parenchymal-injection-of-n-butyl-2-cyanoacrylate-100610663","NCT07230509","Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate","Efficacy of Pancreatic Parenchymal N-Butyl-2-Cyanoacrylate Injection in Pancreaticojejunostomy After Pancreaticoduodenectomy: A Randomized Controlled Trial","NBCA","Inclusion Criteria:\n\n* Patients undergoing pancreaticoduodenectomy for malignant lesions meeting the curative treatment intent in accordance with clinical guidelines.\n* Soft pancreatic texture.\n* Small main pancreatic duct diameter (\\\u003C3 mm).\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Known hypersensitivity to cyanoacrylate or Lipiodol®.\n* Extremely hard, fibrotic pancreas.\n* Significant pancreatitis involving the pancreatic remnant.\n* Active infection at the surgical site.\n* Uncontrolled coagulopathy.\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* Pregnant or breastfeeding women.\n* Patients with serious mental disorders.\n* Patients with vascular invasion and requiring vascular resection.\n* Patients refused to participate in the study.","75 Years",{"count":52,"type":21},90,[54],"PHASE2","This randomized controlled trial investigates the safety and efficacy of injecting N-butyl-2- cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.",[57,28,58,27],"Pancreaticoduodenectomy","Pancreas Cancer",[60,61,62,63,64,65],"Pancreatic surgery","Anastomotic leak","Tissue adhesive","Postoperative Pancreatic Fistula (POPF)","Pancreaticoduodenectomy (PD)","Pancreaticojejunostomy (PJ)","2025-11-30",{"date":68,"type":33},"2025-12-02",{"date":70,"type":33},"2025-12-01",{"date":72,"type":21},"2027-12-20",{"name":74,"class":40},"Minia University",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":94,"locationsCount":41},"100603132","phase-1-salehs-technique-for-pancreaticojejunostomy-pancreatic-parenchymal-injection-of-n-butyl-2-cyanoacrylate-100603132","NCT07132541","Saleh's Technique for Pancreaticojejunostomy (Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate)","Pancreatic Parenchymal Injection of N-Butyl-2-Cyanoacrylate for Pancreaticojejunostomy After Pancreaticoduodenectomy: A Novel Technique",{"count":82,"type":21},30,[84],"PHASE1","This study investigates the safety and efficacy of injecting N-butyl-2-cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.",[57,28,58,27],[60,61,62,63,64,65],"2025-08-25",{"date":90,"type":33},"2025-09-02",{"date":88,"type":33},{"date":93,"type":21},"2026-09-25",{"name":74,"class":40},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100526922","prophylactic-abdominal-drainage-vs-no-drainage-after-distal-pancreatectomy-100526922","NCT06141044","Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy","PANDREAS. Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy: a Multicentre Clinical Trial","PANDREAS","Inclusion Criteria:\n\n* Adult patients (over 18 years of age) undergoing elective distal pancreatectomy surgery for any indication, with or without splenectomy, minimally invasive or open. It is not necessary to integrate gender perspective as it is not relevant and there is no influence on the results of POPF or morbidity.\n* Signed informed consent was obtained from each of the patients included in the study.\n\nExclusion criteria\n\n* Patients undergoing distal pancreatectomy as a secondary procedure\n* Additional liver, gastric or colonic resection\n* Pregnancy\n* Participation in another study\n* History of previous surgery involving the pancreas\n* Patients with American Society of Anaesthesiologists classification 4\n* Arterial resection other than the splenic artery",{"count":104,"type":21},104,[106],"NA","Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.",[28,109,110],"Distal Pancreatectomy","Drainage",[112,109,113],"Postoperative pancreatic fistula","Intraoperative Drainage","NOT_YET_RECRUITING","2023-11-14",{"date":117,"type":33},"2023-11-21",{"date":119,"type":21},"2024-01",{"date":121,"type":21},"2027-12",{"name":123,"class":40},"Clinica Universidad de Navarra, Universidad de Navarra",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":41},"100379465","intrapapillary-botulinum-toxin-injection-for-prevention-of-post-surgical-pancreactic-fistula-100379465","NCT04220931","Intrapapillary Botulinum Toxin Injection for PREvention of Post-surgical PAncREactic Fistula","PREPARE","Inclusion Criteria:\n\n* Patients with scheduled distal pancreatectomy for any indication: open or laparoscopic distal pancreatectomy with or without splenectomy\n* Age ≥ 18years\n\nExclusion Criteria:\n\n* History of myasthenia gravis or Eaton-Lambert syndrome\n* Inflammatory myositis \\\u003C2 years or preexisting motor neuron disease or neuropathies\n* ASA score \\> III\n* Pregnancy or lactation\n* Altered anatomy of the duodenum and\u002For the major papilla (prior surgery, prior endoscopic sphincterotomy)\n* Scheduled pancreaticoduodenectomy (Whipple procedure)\n* Scheduled total pancreatectomy\n* Scheduled central pancreatectomy\n* Scheduled pancreatic enucleation\n* Calcified chronic pancreatitis (suspected on preoperative cross-sectional imaging)\n* Pancreas divisum (suspected on preoperative cross-sectional imaging)\n* Toxin botulinum contraindications (hypersensitivity to albumin or to saccharose, infection or inflammation at the injection site concerned, generalized muscle weakness)\n* Preoperative administration of somatostatin analogs: for long-acting somatostatin analogs, a 1-month washout period is necessary; for short-acting somatostatin analogs, a 24-hours washout period is necessary\n* Any kind of surgical method to reinforce the pancreatic stump:\n* Use of a bioabsorbable patch\n* Use of fibrin glue\n* Use of a ligament patch\n* Tutorship, trusteeship\n* Concurrent participation in other experimental trials\n* Not Affiliation to the French social security\n* Not Ability to give their consent and not written informed consent\n* Distal pancreatectomy extended to neighbouring organs (except spleen and gallbladder) or to the vessels (celiac axis, portal vein)\n\nSecondary exclusion criteria: patients who did not have the planned surgery in less than 4 weeks after the botulinum toxin injection.",{"count":132,"type":21},460,[106],"Surgery is required for the treatment of many pancreatic conditions, either malignant or benign. Mortality of pancreatic surgery can be up to 3% even in expert centers. Morbidity is high, postoperative pancreatic fistula (POPF) being the main postoperative complication. In its current definition (drain output of any measurable fluid \\>= postoperative day 3 with amylase content \\>3 times the serum amylase activity and with clinical consequence), the incidence of postoperative PF is between 15 and 30 %. Most POPF resolve spontaneously but when refractory POPF occurs, it may lead to severe complications. POPF severity is graded as follows: grade B in case of change in medical management: infection without organ failure, specific medication (total parenteral nutrition, somatostatin analogs, antibiotics), persistent drainage \\> 3 weeks, angiographic procedure for bleeding, prolonged hospital stay; grade C in case of reoperation or PF-related organ failure or death.\n\nNo specific prophylactic treatment of POPF is currently recommended by clinical guidelines. In clinical research, many prophylactic strategies have been attempted with partial efficacy. Endoscopic pancreatic sphincterotomy with plastic stent placement is effective in pre-and postoperative management of pancreatic fistula but with the need of a highly competent interventional endoscopist. Intrapapillary botulinum toxin injection is believed to induce relaxation of the pancreatic sphincter, leading to a \" pharmacological \" pancreatic sphincterotomy without any morbidity.\n\nA recent phase I\u002FII prospective study has shown promising results in this indication, with no clinically relevant pancreatic fistula when botulinum toxin was injected. Based on this observation we hypothesize that intrapapillary botulinum toxin injection during an endoscopic procedure before surgery could be effective for the prevention of post-surgical pancreatic fistula",[109,28],[137],"distal pancreatectomy","2023-07-07",{"date":140,"type":33},"2023-07-10",{"date":142,"type":33},"2023-03-27",{"date":144,"type":21},"2027-03-01",{"name":146,"class":40},"Assistance Publique - Hôpitaux de Paris"]