Fibrin Sealant for Cholangiotomy Closure Study

September 8, 2015 updated by: BAHMAN DARKAHI, Lasarettet i Enköping

Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy

Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic common bile duct exploration is a way of dealing with common bile duct stones that has gained increasing acceptance. Following a cholangiotomy there is, however, the risk of bile leakage from the incision.

A way of avoiding leakage following cholangiotomy may be to apply fibrin sealant on the cholangiotomy.

The present study is based on patients undergoing laparoscopic cholecystectomy at the department of surgery, Enköping hospital, Sweden. The patients are informed about the study prior to the procedure. Cholangiography is performed routinely. In case common bile duct stones are encountered on the cholangiography, an incision is made in the common bile duct and the stones are extracted. After the stone extraction, a t tube is introduced into the cholangiotomy and the incision is closed with running Vicryl sutures.

When the cholangiotomy has been closed, the randomisation is performed with a sealed envelope system. If the patient is randomised to fibrin sealant, this is applied on the cholangiotomy. A passive drain is introduced before the abdomen is closed.

Postoperatively, the amount of bile in the passive drain is measured by an observer randomised to the allocation.

If the amount of bile in the drain does not exceed 100 ml three days postoperatively, a secondary cholangiography is performed through the t tube. If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.

All postoperative complications are registered according to the Clavien-Dindo system.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

  • Sweden
    • Uppsala
      • Enkoping, Uppsala, Sweden, 754 25
        • Recruiting
        • Lasarettet i Enkoping
        • Contact:
        • Principal Investigator:
          • Bahman Darkahi, MD
        • Sub-Investigator:
          • Gabriel Sandblom, MD

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gallbladder disease

Exclusion Criteria:

  • Cancer/Tumor

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fibrin sealant
Tisseel, Baxter (Aprotinin and Fibrinogen)
Drug: Tisseel, Baxter (Aprotinin and Fibrinogen)
After introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision.
Other Names:
  • Closing the incision with fibrin sealant
Placebo Comparator: Control
Suturing the incision without fibrin glue
Drug: Control
No fibrin sealant applied
Other Names:
  • Closing the incision without fibrin sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative biliary leakage
Time Frame: From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks
The amount of bile in the drain is measured daily until it is withdrawn
From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks

Collaborators and Investigators

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

Sponsor

Lasarettet i Enköping

Investigators

  • Principal Investigator: Gabriel Sandblom, Assoc Prof, Karolinska Institutet, Stockholm, Sweden

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, 2009

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

September 8, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • glue 55 galla

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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