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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatectomy Post Procedural Discharge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early drain removal

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

Group Type EXPERIMENTAL

Early drain removal

Intervention Type OTHER

Removing drain(s) on postoperative day 3

Late drain removal

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

Group Type EXPERIMENTAL

Late drain removal

Intervention Type OTHER

Removing drain(s) on postoperative day 4 or later

Interventions

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Early drain removal

Removing drain(s) on postoperative day 3

Intervention Type OTHER

Late drain removal

Removing drain(s) on postoperative day 4 or later

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No