Fibrin Sealant for Cholangiotomy Closure Study

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02545153
• Other study ID #: glue 55 galla
• Status: Recruiting
• Phase: Phase 2
• First received: October 10, 2012
• Last updated: September 8, 2015
• Start date: January 2009
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Lasarettet i Enköping
• Contact: Bahman Darkahi Darkahi, MD
• Email: bahman.darkahi[@]lul.se
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial Summary

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

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 If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Gallbladder disease

Exclusion Criteria:

• Cancer/Tumor

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Leak
• Common Bile Duct Gall Stones
• Infection

Intervention

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.
• Control
No fibrin sealant applied

Locations

Country	Name	City	State
Sweden	Lasarettet i Enkoping	Enkoping	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Lasarettet i Enköping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes