[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526922":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":12,"responsibleParty":40,"collaborators":12,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":12,"enrollmentInfo":52,"targetDuration":12,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":65,"whyStopped":12,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":12},{"fullName":5,"class":6},"Clinica Universidad de Navarra, Universidad de Navarra","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Drainage","NO_INTERVENTION","Patients undergoing distal pancreatectomy with surgical drainage.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"No drainage","EXPERIMENTAL","Patients undergoing distal pancreatectomy without surgical drainage.",[18],"Procedure: Avoid surgical drainage",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"PROCEDURE","Avoid surgical drainage","Patients who undergo distal pancreatectomy, avoid placing a drain.",[14],[26],{"name":27,"affiliation":28,"role":29},"Fernando Rotellar, MD, PhD","Clínica Universidad de Navarra","STUDY_DIRECTOR",[31,36],{"name":27,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","948255400","4729","frotellar@unav.es",{"name":37,"role":32,"phone":33,"phoneExt":38,"email":39},"Nuria Blanco","4714","nblancoasen@unav.es",{"type":41,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","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":53,"type":54},104,"ESTIMATED","INTERVENTIONAL",[57],"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.",[60,61,9],"Postoperative Pancreatic Fistula","Distal Pancreatectomy",[63,61,64],"Postoperative pancreatic fistula","Intraoperative Drainage","NOT_YET_RECRUITING","2023-11-14",{"date":68,"type":69},"2023-11-21","ACTUAL",{"date":71,"type":54},"2024-01",{"date":73,"type":54},"2027-12",{"name":5,"class":6}]