The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.

Karolinska University Hospital

Status: Completed

Conditions: Bile Leakage

Treatments: Device: Transpapillary plastic stent (7-10 Fr)

Study type: Interventional

Funder types: Other

Identifiers

NCT01960712

2006/1142-31/3 (Other Identifier)

Details and patient eligibility

About

Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.

Full description

All patients who present with clinically significant bile leakage after liver resection at postoperative day two or longer are offered the opportunity to become randomized to either continuous external drainage or the addition of transpapillary stent.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Liver resection including at least two liver segments.

Exclusion criteria

• Hepatobiliary digestive anastomosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Continued external drainage

No Intervention group

Description:

Continued external drainage alone.

Continued external drainage + transpapillary stent

Active Comparator group

Description:

External drainage + transpapillary plastic stent (7-10 Fr).

Treatment:

Device: Transpapillary plastic stent (7-10 Fr)