The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.

October 2, 2020 updated by: Lars Lundell, Karolinska University Hospital
Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients who present with clinically significant bile leakage after liver resection at postoperative day two or longer are offered the opportunity to become randomized to either continuous external drainage or the addition of transpapillary stent.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University 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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Liver resection including at least two liver segments.

Exclusion Criteria:

  • Hepatobiliary digestive anastomosis.

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Continued external drainage
Continued external drainage alone.
Active Comparator: Continued external drainage + transpapillary stent
External drainage + transpapillary plastic stent (7-10 Fr).
Device: Transpapillary plastic stent (7-10 Fr)
Duodenoscopy plus transpapillary bile cannulation plus stent insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of days of bile leakage from the abdominal cavity
Time Frame: From intervention until day discharge from hospital
From intervention until day discharge from hospital

Secondary Outcome Measures

Outcome Measure
Time Frame
General complications rates. Postoperative hospital stay
Time Frame: From intervention until day of discharge from hospital
From intervention until day of discharge from hospital

Collaborators and Investigators

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

Sponsor

Karolinska University Hospital

Collaborators

Jansson, Anders, M.D.

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

November 1, 2008

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 11, 2013

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2006/1142-31/3 (Other Identifier: 2006/1142-31/3)

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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