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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02545153
Other study ID # glue 55 galla
Secondary ID
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 If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.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


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
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