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.
AIM we aim to compare postoperative surgical outcomes after PD in patients with low/medium risk for POPF (ISGPS risk class A-B-C), who undergo POD1 drains removal versus POD3 removal.
Primary aim: 1) grade B/C 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.
Study Design:
This is a randomized, controlled, open-label study. All patients will be randomized on POD1, using computer-generated randomization codes.
Group A: Drain removal on POD 1 (in case of POD 1 DFA\< 300 U/L) Group B: Drain removal on POD 3 (in case of POD 1 DFA\< 300 U/L)
Patients (age ≥ 18 or < 85 years) undergoing elective pancreaticoduodenectomy providing informed consent.
Intraoperative low to moderate risk for POPF (ISGPS class A-B-C)
POD 1 DFA < 300U/L
Age <18 or >85
Patients with high risk of developing pancreatic fistula (ISGPS class D)
Intraoperative positioning of external or internal pancreatic stent
POD 1 DFA ≥300
Casa di Cura Dott. Pederzoli
Lead sponsor
University of Padova
Collaborator