[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515542":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Retromesenteric omental flap covering all exposed peripancreatic arteries","EXPERIMENTAL","A J-shaped omental flap is created by extensive mobilization of the greater omentum, and if needed, lengthening by division of vertical collaterals of gastroepiploic vessels section or thinning it out in patients with visceral obesity. This omental flap is ascended through the retromesentric route to cover all the peri-pancreatic vessels at risk of bleeding after pancreatic resection (hepatic artery, proximal part of the splenic artery, superior mesenteric artery, and right hepatic artery originating from superior mesenteric artery when present)",[13],"Procedure: Pancreaticoduodenectomy with retromesenteric omental flap",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","No omental flap or an omental flap not using the retromesenteric route and only interposed between the pancreatic anastomosis and the hepatic artery, or a single round ligament flap wrapping the hepatic artery only.",[19],"Procedure: Pancreaticoduodenectomy without retromesenteric omental flap",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Pancreaticoduodenectomy without retromesenteric omental flap","Resection of the pancreatic head, duodenum, distal common bile duct and gallbladder followed by reconstruction using pancreaticojejunostomy, hepaticojejunostomy, and gastrojejunostomy performed on the first jejunal loop.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Pancreaticoduodenectomy with retromesenteric omental flap","All exposed peripancratic arteries should be covered with a retromesentric omental flap",[9],[32],{"name":33,"affiliation":5,"role":34},"Alain SAUVANET, MD, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","+33140875948","33","alain.sauvanet@aphp.fr",{"name":42,"role":37,"phone":26,"phoneExt":26,"email":43},"Safi DOKMAK, MD. PhD","safi.dokmak@aphp.fr",[45],{"facility":46,"status":47,"city":48,"state":26,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Beaujon Hospital","RECRUITING","Clichy","92118","France","FR",{"type":53,"coordinates":54},"Point",[55,56],2.30952,48.90018,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":26,"phoneExt":26,"email":40},"Alain SAUVANET, MD, PHD",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100515542","pancreaticoduodenectomies-with-complete-arterial-coverage-by-retromesenteric-omentoplasty-100515542",false,"NCT05992857","Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty","Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.","PACOMARCO","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients requiring a pancreaticoduodenectomy (PD) for any indication\n* Open approach\n* Affiliation to the French public healthcare insurance\n* Fistula risk score (FRS) ≥ 7 confirmed intraoperatively\n* Ability to understand and to comply with the study protocol\n* Reconstruction with PJ and external pancreatic stent\n* Signed written informed consent\n* Inclusion is allowed for patients:\n\n  * On curative or long-term anticoagulation or aspirin (indicated for previous thromboembolic complications, heart disease, previous history of stroke)\n  * Undergoing PD with venous resection\n\nExclusion Criteria:\n\n* Presence of distant tumor deposits (liver and peritoneal metastases, and\u002For para-aortic lymph nodes metastases) reveals during intraoperative exploration for patient with malignant pancreatic or periampullary tumor.\n* Patients with previous abdominal surgery compromising completion of retromesenteric omentoplasty\n* PD with arterial resection (i.e. resection of hepatic artery, splenic artery, superior mesenteric artery, or celiac axis)\n* Laparoscopic or robotic PD\n* Reconstruction wih pancreatico-gastrostomy\n* Total pancreatectomy\n* Emergency procedure\n* Pregnant women\n* Patient under guardianship and curatorship\n* Participation in another interventional study evaluating complication after pancreaticoduodenectomy or patient still being in the exclusion period at the end of a previous study evaluating drugs.","ALL","18 Years",{"count":74,"type":75},150,"ESTIMATED","INTERVENTIONAL",[78],"NA","To assess the efficacy of complete covering using retromesenteric omentoplasty vs. partial covering or no covering of peripancreatic arteries in decreasing incidence of grade B+C post-pancreatectomy hemorrhage (PPH), i.e. treated by transfusion and \u002F or radiological or surgical hemostasis after PD in patients with high risk of POPF.",[81,82],"Pancreatectomy","Complication of Surgical Procedure",[84,85,86,87],"Pancreaticoduodenectomy","Post-pancreatectomy haemorrhage","Omentoplasty","Post-operative pancreatic fistula","2025-11-17",{"date":90,"type":91},"2025-11-18","ACTUAL",{"date":93,"type":91},"2024-10-22",{"date":95,"type":75},"2027-01",{"name":5,"class":6},1]