[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"distal-pancreatectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:distal-pancreatectomy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100526922","prophylactic-abdominal-drainage-vs-no-drainage-after-distal-pancreatectomy-100526922",false,"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","ALL","18 Years",{"count":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Postoperative Pancreatic Fistula","Distal Pancreatectomy","Drainage",[31,28,32],"Postoperative pancreatic fistula","Intraoperative Drainage","NOT_YET_RECRUITING","2023-11-14",{"date":36,"type":37},"2023-11-21","ACTUAL",{"date":39,"type":21},"2024-01",{"date":41,"type":21},"2027-12",{"name":43,"class":44},"Clinica Universidad de Navarra, Universidad de Navarra","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"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":53,"type":21},460,[24],"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",[28,27],[58],"distal pancreatectomy","RECRUITING","2023-07-07",{"date":62,"type":37},"2023-07-10",{"date":64,"type":37},"2023-03-27",{"date":66,"type":21},"2027-03-01",{"name":68,"class":44},"Assistance Publique - Hôpitaux de Paris",1]