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

NCT ID: NCT00990366

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-11-30

Brief Summary

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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

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Conditions

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Biliary Obstruction Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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biliary stent without an antireflux valve

patients with biliary obstruction who need a biliary stent, selected for the stent without an antireflux valve arm

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

arms are assigned randomly by closed envelope method

biliary stent with an antireflux valve

patients with biliary obstruction, who need a biliary stent, selected for the stent with an antireflux valve arm

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

arms are assigned randomly by closed envelope method

Interventions

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

arms are assigned randomly by closed envelope method

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hanna Vihervaara

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulina Salminen, MD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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58/180/2009

Identifier Type: -

Identifier Source: org_study_id