Early Versus Late Drain Removal After Pancreatectomy: A Randomized Prospective Trial

Peking Union Medical College Hospital144 enrolled

Overview

The aim of this study is to demonstrate the hypothesis that early removal of drain can reduce the incidence of intra-abdominal infection and pancreatic fistula after pancreatectomy compared with later removal of drain.

This study is to analyze the association between the time of removal of drain after pancreatic resection and incidence of intra-abdominal complications, such as intra-abdominal infection and pancreatic leakage. We design a prospective randomized study. Patients with pancreatic and periampullar tumors who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) are recruited to the study if amylase value in drain(s) is less than 5000 U/L on postoperative day (POD) 1. 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 4 or beyond. The primary outcomes are the incidence of intra-abdominal infection and pancreatic fistula; the secondary outcomes include intra-abdominal bleeding, delayed gastric emptying, pulmonary complications, and length of hospital stay.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

144

Conditions

Pancreatectomy Post Procedural Discharge

Interventions

Early drain removalOTHER

Removing drain(s) on postoperative day 3

Late drain removalOTHER

Removing drain(s) on postoperative day 4 or later

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: \>18yr, \<75yr * Patients with pancreatic diseases (including tumor and inflammatory disease) or non-pancreatic tumors (biliary duct cancer or ampullary tumor) who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) * The amylase value in drain(s) is less than 5000 U/L on postoperative day 1 and 3. Exclusion Criteria: * Reconstruction of the pancreatic remnant by pancreaticogastrostomy * Intra-abdominal hemorrhage within 72 hours after operation * Biliary fistula (output of biliary fluid from at least 1 abdominal drain) within 72 hours after operation * Chylous leakage (milky water) within 72 hours after operation * The volume of drain effluent (ascites) is greater than 300 ml within 72 hours after operation.

Locations (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Intra-abdominal infection

Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.