Fibrin Sealant for Cholangiotomy Closure Study
Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy
  • Phase

    Phase 2
  • Study Type

  • Status

    Unknown status
  • Intervention/Treatment

    human fibrin ...
  • Study Participants

Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.
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 If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.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 Started
Jan 31
Primary Completion
Jan 31
Study Completion
Dec 31
Last Update
Sep 09

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 names: Closing the incision with fibrin sealant

Drug Control

No fibrin sealant applied

  • Other names: Closing the incision without fibrin sealant

Fibrin sealant Active Comparator

Tisseel, Baxter (Aprotinin and Fibrinogen)

Control Placebo Comparator

Suturing the incision without fibrin glue


Inclusion Criteria:

Gallbladder disease

Exclusion Criteria:

No Results Posted