Fibrin Sealant for Cholangiotomy Closure Study
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|ClinicalTrials.gov Identifier: NCT02545153|
Recruitment Status : Unknown
Verified September 2015 by BAHMAN DARKAHI, Lasarettet i Enköping.
Recruitment status was: Recruiting
First Posted : September 9, 2015
Last Update Posted : September 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Common Bile Duct Gall Stones Infection Bile Leak||Drug: Tisseel, Baxter (Aprotinin and Fibrinogen) Drug: Control||Phase 2|
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 If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Fibrin sealant
Tisseel, Baxter (Aprotinin and Fibrinogen)
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.
Other Name: Closing the incision with fibrin sealant
Placebo Comparator: Control
Suturing the incision without fibrin glue
No fibrin sealant applied
Other Name: Closing the incision without fibrin sealant
- Postoperative biliary leakage [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545153
|Contact: Bahman Darkahi Darkahi, MDfirstname.lastname@example.org|
|Lasarettet i Enkoping||Recruiting|
|Enkoping, Uppsala, Sweden, 754 25|
|Contact: Bahman Darkahi, MD email@example.com|
|Principal Investigator: Bahman Darkahi, MD|
|Sub-Investigator: Gabriel Sandblom, MD|
|Principal Investigator:||Gabriel Sandblom, Assoc Prof||Karolinska Institutet, Stockholm, Sweden|