Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

Peking Union Medical College Hospital319 enrolled

Overview

The aim of this randomized prospective multicenter study is to demonstrate the hypothesis that early removal of drain could reduce the incidence of major complications (grade 2-4) after pancreaticoduodenectomy (PD) , when compared with later removal of drain.

The objective of this randomized prospective multicenter study is to investigate the association between the time of removal of drain after pancreaticoduodenectomy (PD) and incidence of major complications (grade 2-4 complications). The investigators unite six pancreatic surgery center in Beijing. Patients who underwent pancreaticoduodenectomy (PD) or pylorus-preserving pancreaticoduodenectomy (PPPD) with low to moderate risk of post-operative pancreatic fistula (POPF) are recruited into the study. After obtaining informed consent, eligible patients are randomly allocated to early or late drain removal group on POD 3. In the group A, drain(s) are removed on POD 3, whereas in group B drain is removed on POD 5 or beyond. The primary outcomes are the incidence of sum of grade 2-4 complications, the secondary outcomes include grade B/C POPF, intra-abdominal infeciton, delayed gastric emptying, post-operative bleeding, in-hospital stay, total medical cost and comprehensive complication index (CCI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

319

Conditions

Pancreaticoduodenectomy Drainage

Interventions

Early drain removalOTHER

Removing drain(s) on postoperative day 3

Late drain removalOTHER

Removing drain(s) on postoperative day 5 or later

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. PD with or without pylorus preserving; 2. Age between 18 and 75 years; 3. Drain amylase on POD 1 and 3 less than 5000 U/L; 4. Drain output within POD 3 less than 300 ml per day. Exclusion Criteria: 1. Vascular reconstruction using an artificial graft; 2. Grade B/ C postoperative bleeding, evident anastomosis leakage within 3 days after surgery; 3. Refusale to participate in after signed informed consent.

Locations (1)

Peking Union Medical College Hospital

Beijing, China

Outcomes

Primary Outcomes

The sum of grade 2- 4 complications

The severity of complication was measured by Clavein Dindo classifications and grade 2- 4 complications always affect the recovery of the patients significantly.However, the death case (grade 5 complication) is rare now for PD in high volume centers. According to our single center study, early drain removal could reduce the rate of grade 2-4 complications by 12% for the patients undergoing major pancreatectomy.