Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

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

COMPLETED

Clinical Phase

NA

Total Enrollment

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Pancreaticoduodenectomy Drainage

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 = 166)

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 5 or later (n = 166)

Group Type ACTIVE_COMPARATOR

Late drain removal

Intervention Type OTHER

Removing drain(s) on postoperative day 5 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 5 or later

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No