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

October 10, 2011 updated by: Hanna Vihervaara, Turku University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20520
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: biliary stent without an antireflux valve
patients with biliary obstruction who need a biliary stent, selected for the stent without an antireflux valve arm
Device: Cook´s biliary stent with an antireflux stent, normal biliary stent
arms are assigned randomly by closed envelope method
ACTIVE_COMPARATOR: biliary stent with an antireflux valve
patients with biliary obstruction, who need a biliary stent, selected for the stent with an antireflux valve arm
Device: Cook´s biliary stent with an antireflux stent, normal biliary stent
arms are assigned randomly by closed envelope method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patency of a biliary stent
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Cholangitis
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Paulina Salminen, MD, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (ESTIMATE)

October 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 10, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58/180/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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