Fibrin Sealant for Cholangiotomy Closure Study

Lasarettet i Enköping

Status and phase: Unknown; Phase 2

Conditions: Infection; Bile Leak; Common Bile Duct Gall Stones

Treatments: Drug: Tisseel, Baxter (Aprotinin and Fibrinogen); Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02545153

glue 55 galla

Details and patient eligibility

About

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

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 If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gallbladder disease

Exclusion criteria

• Cancer/Tumor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Fibrin sealant

Active Comparator group

Description:

Tisseel, Baxter (Aprotinin and Fibrinogen)

Treatment:

Drug: Tisseel, Baxter (Aprotinin and Fibrinogen)

Control

Placebo Comparator group

Description:

Suturing the incision without fibrin glue

Treatment:

Drug: Control