Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve

Not Applicable

Terminated

• Conditions: Biliary Obstruction; Cholangitis
• Interventions: Device: Cook´s biliary stent with an antireflux stent, normal biliary stent

• Registration Number: NCT00990366
• Lead Sponsor: Turku University Hospital

Brief Summary

Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. Stents with antireflux valves are designed to reduce the reflux from the bowel. The purpose of the study is to investigate prospectively whether it is possible to reduce the amount of infection and thus obstruction of biliary stent by using a stent with an antireflux valve compared to a normal stent without an antireflux valve.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-06
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-10
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• age 18-89
• biliary obstruction in the lower two thirds of the choledochus

Exclusion Criteria

• allergy to contrast media
• future pancreaticoduodenectomy
• refusal from the study
• previous stent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
biliary stent without an antireflux valve	Cook´s biliary stent with an antireflux stent, normal biliary stent	patients with biliary obstruction who need a biliary stent, selected for the stent without an antireflux valve arm
biliary stent with an antireflux valve	Cook´s biliary stent with an antireflux stent, normal biliary stent	patients with biliary obstruction, who need a biliary stent, selected for the stent with an antireflux valve arm

Primary Outcome Measures

Name	Time	Method
patency of a biliary stent	one year

Secondary Outcome Measures

Name	Time	Method
Cholangitis	one year

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland