Fibrin Sealant for Cholangiotomy Closure Study

Phase 2

• Conditions: Bile Leak; Common Bile Duct Gall Stones; Infection
• Interventions: Drug: Control; Drug: Tisseel, Baxter (Aprotinin and Fibrinogen)

• Registration Number: NCT02545153
• Lead Sponsor: Lasarettet i Enköping

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 If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.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

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-10-10
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-08
• Last Update Submitted: 2015-09-08
• Study First Posted: 2015-09-09
• Last Update Posted: 2015-09-09
• Primary Completion: 2016-01
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Gallbladder disease

Exclusion Criteria

• Cancer/Tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Suturing the incision without fibrin glue
Fibrin sealant	Tisseel, Baxter (Aprotinin and Fibrinogen)	Tisseel, Baxter (Aprotinin and Fibrinogen)

Primary Outcome Measures

Name	Time	Method
Postoperative biliary leakage	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

Trial Locations

Locations (1)

Lasarettet i Enkoping; 🇸🇪 Enkoping, Uppsala, Sweden