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Fibrin Sealant for Cholangiotomy Closure Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
BAHMAN DARKAHI, Lasarettet i Enköping

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

Condition or disease Intervention/treatment Phase
Common Bile Duct Gall Stones Infection Bile Leak Drug: Tisseel, Baxter (Aprotinin and Fibrinogen) Drug: Control Phase 2

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 If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aprotinin

Arm Intervention/treatment
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
Drug: Control
No fibrin sealant applied
Other Name: Closing the incision without fibrin sealant




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gallbladder disease

Exclusion Criteria:

  • Cancer/Tumor

Information from the National Library of Medicine

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


Contacts
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Contact: Bahman Darkahi Darkahi, MD bahman.darkahi@lul.se

Locations
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Sweden
Lasarettet i Enkoping Recruiting
Enkoping, Uppsala, Sweden, 754 25
Contact: Bahman Darkahi, MD       bahman.darkahi@lul.se   
Principal Investigator: Bahman Darkahi, MD         
Sub-Investigator: Gabriel Sandblom, MD         
Sponsors and Collaborators
Lasarettet i Enköping
Investigators
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Principal Investigator: Gabriel Sandblom, Assoc Prof Karolinska Institutet, Stockholm, Sweden
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Responsible Party: BAHMAN DARKAHI, MD, Lasarettet i Enköping
ClinicalTrials.gov Identifier: NCT02545153    
Other Study ID Numbers: glue 55 galla
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Fibrin Tissue Adhesive
Aprotinin
Hemostatics
Coagulants
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action