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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00990366

Enrollment

Registered

2009-10-06

Start date

2009-10-31

Completion date

2010-11-30

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Obstruction, Cholangitis

Keywords

antireflux valve, biliary obstruction, cholangitis, biliary stent

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.

Interventions

DEVICECook´s biliary stent with an antireflux stent, normal biliary stent

arms are assigned randomly by closed envelope method

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
patency of a biliary stent	one year

Secondary

Measure	Time frame
Cholangitis	one year

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026