Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

April 21, 2020 updated by: Peking Union Medical College Hospital

A Randomized Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

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.

Study Overview

Detailed Description

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

Enrollment (Actual)

319

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early drain removal
Removing drain(s) on postoperative day 3 (n = 166)
Removing drain(s) on postoperative day 3
ACTIVE_COMPARATOR: Late drain removal
Removing drain(s) on postoperative day 5 or later (n = 166)
Removing drain(s) on postoperative day 5 or later

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sum of grade 2- 4 complications
Time Frame: Up to postoperative 90 days
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.
Up to postoperative 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-abdominal bleeding
Time Frame: Up to postoperative 90 days
The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
Up to postoperative 90 days
Delayed gastric emptying
Time Frame: Up to postoperative 90 days
The International Study Group of Pancreatic Surgery (ISGPS) definition: Inability to return to a standard diet by the end of the first postoperative week with prolonged nasogastric intubation.
Up to postoperative 90 days
Grade B/C complications
Time Frame: Up to postoperative 90 days
The International Study Group of Pancreatic Surgery (ISGPS) definition
Up to postoperative 90 days
Length of hospital stay (day)
Time Frame: Up to postoperative 90 days
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Up to postoperative 90 days
Comprehensive complication index (CCI)
Time Frame: Up to postoperative 90 days
integrates all complications of the Clavien-Dindo classification (CDC) and offers a metric approach to measure morbidity.
Up to postoperative 90 days
Interventional treatment
Time Frame: Up to postoperative 90 days
interventional treatment for any complication.
Up to postoperative 90 days
Total medical expenses
Time Frame: Up to postoperative 90 days
Total medical expenses during hospitalization.
Up to postoperative 90 days
Any other single intem of grade 2-4 complication
Time Frame: Up to postoperative 90 days
Clavein Dindo Classification is adopted.
Up to postoperative 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

April 1, 2020

Study Registration Dates

First Submitted

February 14, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (ACTUAL)

February 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PUMCH-GS05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After this multicenter randomized clinical trail complete, the results of this study will be submitted to and published in a peer-reviewing journal. Other researchers can assess our article through electronic database, such as Medline/PubMed.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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