[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreas-fistula-abdominal-drains\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreas-fistula-abdominal-drains":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100552117","first-day-versus-early-drain-removal-following-pd-a-randomized-controlled-trial-100552117",false,"NCT06468917","First-day Versus Early Drain Removal Following PD: a Randomized Controlled Trial","First-day Versus Early Drain Removal Following Pancreaticoduodenectomy: a Randomized Controlled Trial","FIDEL","Inclusion Criteria:\n\n* Patients (age ≥ 18 or \\\u003C 85 years) undergoing elective pancreaticoduodenectomy providing informed consent.\n* Intraoperative low to moderate risk for POPF (ISGPS class A-B-C)\n* POD 1 DFA \\\u003C 300U\u002FL\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>85\n* Patients with high risk of developing pancreatic fistula (ISGPS class D)\n* Intraoperative positioning of external or internal pancreatic stent\n* POD 1 DFA ≥300\n* Sinister appearance of drain effluent (defined as dark brown to clear \"spring water\" fluid that looks like pancreatic juice contaminated) as mentioned in literature3-22\n* Early post-pancreatectomy hemorrhage\n* Intraoperative conditions different from POPF risk, requiring prolonged intrabdominal drains\n* Previous bilio\u002Fpancreatic surgery\n* Allergy to drain materials\n* Significant coagulation disorders\n* Patients unable to provide informed consent.\n* Clinical suspect of another surgery-related fistula different than POPF","ALL","18 Years","85 Years",{"count":21,"type":22},224,"ESTIMATED","INTERVENTIONAL",[25],"NA","Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula (POPF) with variable impact on clinical outcome. Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity. The optimal timing for drain removal after PD is still a subject of debate: most studies have shown that outcomes are best when ID are removed in postoperative day (POD) 3 when POPF is excluded.\n\nAIM we aim to compare postoperative surgical outcomes after PD in patients with low\u002Fmedium risk for POPF (ISGPS risk class A-B-C), who undergo POD1 drains removal versus POD3 removal.\n\nPrimary aim: 1) grade B\u002FC POPF; 2) post-pancreatectomy hemorrhage (PPH). Secondary aims: occurrence of fluid collection, sepsis, SSI, need for reintervention, length of stay, CD\\>3, 90 days mortality, re-admission.\n\nStudy Design:\n\nThis is a randomized, controlled, open-label study. All patients will be randomized on POD1, using computer-generated randomization codes.\n\nGroup A: Drain removal on POD 1 (in case of POD 1 DFA\\\u003C 300 U\u002FL) Group B: Drain removal on POD 3 (in case of POD 1 DFA\\\u003C 300 U\u002FL)",[28],"Pancreas Fistula Abdominal Drains",[30],"pancreatic fistula pancreaticoduodenectomy drain fluid amylase","RECRUITING","2024-06-20",{"date":34,"type":35},"2024-06-21","ACTUAL",{"date":37,"type":35},"2024-06-01",{"date":39,"type":22},"2026-03-30",{"name":41,"class":42},"Casa di Cura Dott. Pederzoli","OTHER"]