简介：AbstractObjectives:Timing of drain removal and its effects on complications after major pancreatectomy remain controversial. We designed this study to assess whether early drain removal after major pancreatectomy influences the incidence of complications in the patients with low risk of postoperative pancreatic fistula (POPF).Methods:This is a single-center randomized controlled trial (RCT). A total of 144 patients undergoing pancreaticoduodenectomy (PD) and distal pancreatectomy (DP) who met the criteria, including drain amylase on postoperative day (POD) 1 and 3 less than 5000 U/L and drain output within POD 3 less than 300 mL/d, were randomly assigned to early drain removal (POD 3) or standard drain removal (≥POD 5). The primary outcome was major complications (Clavien-Dindo grades 2-4), and the secondary outcome was POPF, reintervention treatment, readmission, and total medical expense within 3 months after surgery.Results:A total of 5 patients in early drain removal group had at least 1 major complications (grades 2-4), compared to 15 patients in standard drain removal group (P=.028). The incidence of grade B/C pancreatic fistula was not significantly different (2.8% vs 0%). Multivariate analysis demonstrated that early drain removal was an independent factor associated with a reduced risk of major complications (P=.039, odds ratio=0.314). Majority of major complications occurred in PD patients, and only very few cases occurred in DP patients. Stratified analysis showed that early drain removal significantly reduced the major complications only in the patients undergoing PD.Conclusion:This single-center RCT shows early drain removal on POD 3 is safe for both DP and PD patients, under our criteria. Early drain removal could reduce the incidence of major complications in patients undergoing PD.