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Fibrin Sealant for Cholangiotomy Closure Study

Primary Purpose

Common Bile Duct Gall Stones, Infection, Bile Leak

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Tisseel, Baxter (Aprotinin and Fibrinogen)
Control
Sponsored by
Lasarettet i Enköping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Gall Stones

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gallbladder disease

Exclusion Criteria:

  • Cancer/Tumor

Sites / Locations

  • Lasarettet i EnkopingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fibrin sealant

Control

Arm Description

Tisseel, Baxter (Aprotinin and Fibrinogen)

Suturing the incision without fibrin glue

Outcomes

Primary Outcome Measures

Postoperative biliary leakage
The amount of bile in the drain is measured daily until it is withdrawn

Secondary Outcome Measures

Full Information

First Posted
October 10, 2012
Last Updated
September 8, 2015
Sponsor
Lasarettet i Enköping
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1. Study Identification

Unique Protocol Identification Number
NCT02545153
Brief Title
Fibrin Sealant for Cholangiotomy Closure Study
Official Title
Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lasarettet i Enköping

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Gall Stones, Infection, Bile Leak

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fibrin sealant
Arm Type
Active Comparator
Arm Description
Tisseel, Baxter (Aprotinin and Fibrinogen)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Suturing the incision without fibrin glue
Intervention Type
Drug
Intervention Name(s)
Tisseel, Baxter (Aprotinin and Fibrinogen)
Other Intervention Name(s)
Closing the incision with fibrin sealant
Intervention Description
After introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision.
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
Closing the incision without fibrin sealant
Intervention Description
No fibrin sealant applied
Primary Outcome Measure Information:
Title
Postoperative biliary leakage
Description
The amount of bile in the drain is measured daily until it is withdrawn
Time Frame
From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gallbladder disease Exclusion Criteria: Cancer/Tumor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahman Darkahi Darkahi, MD
Email
bahman.darkahi@lul.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Sandblom, Assoc Prof
Organizational Affiliation
Karolinska Institutet, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lasarettet i Enkoping
City
Enkoping
State/Province
Uppsala
ZIP/Postal Code
754 25
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahman Darkahi, MD
Email
bahman.darkahi@lul.se
First Name & Middle Initial & Last Name & Degree
Bahman Darkahi, MD
First Name & Middle Initial & Last Name & Degree
Gabriel Sandblom, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34129409
Citation
Darkahi B, Norden T, Sandblom G. Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):171-175. doi: 10.1089/lap.2020.0404. Epub 2021 Jun 14.
Results Reference
derived

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Fibrin Sealant for Cholangiotomy Closure Study

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