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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Post Procedural Discharge; Pancreatectomy

Treatments: Other: Early drain removal; Other: Late drain removal

Study type: Interventional

Funder types: Other

Identifiers

NCT02230436

PUMCH-GS02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Early drain removal

Experimental group

Description:

Removing drain(s) on postoperative day 3 (n = 72)

Treatment:

Other: Early drain removal

Late drain removal

Experimental group

Description:

Removing drain(s) on postoperative day 4 or later (n = 72)

Treatment:

Other: Late drain removal