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

Bile Leakage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960712
• Other study ID #: 2006/1142-31/3
• Secondary ID: 2006/1142-31/3
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: May 2017

Study information

• Verified date: October 2020
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Liver resection including at least two liver segments.

Exclusion Criteria:

• Hepatobiliary digestive anastomosis.

Related Conditions & MeSH terms

• Bile Leakage

Intervention

Device:
• Transpapillary plastic stent (7-10 Fr)
Duodenoscopy plus transpapillary bile cannulation plus stent insertion.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Jansson, Anders, M.D.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days of bile leakage from the abdominal cavity		From intervention until day discharge from hospital
Secondary	General complications rates. Postoperative hospital stay		From intervention until day of discharge from hospital