Fibrin Sealant for Cholangiotomy Closure Study

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

Detailed Description
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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 If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.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.

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

Conditions
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Common Bile Duct Gall Stones, Infection, Bile Leak

Intervention / Treatment
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* Drug: Tisseel, Baxter (Aprotinin and Fibrinogen)
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gallbladder disease Exclusion Criteria: Cancer/Tumor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative biliary leakage | 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 |