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

Primary Purpose

Biliary Obstruction, Cholangitis

Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Cook´s biliary stent with an antireflux stent, normal biliary stent
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Obstruction focused on measuring antireflux valve, biliary obstruction, cholangitis, biliary stent

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

biliary stent without an antireflux valve

biliary stent with an antireflux valve

Arm Description

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

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

Outcomes

Primary Outcome Measures

patency of a biliary stent

Secondary Outcome Measures

Cholangitis

Full Information

First Posted
October 5, 2009
Last Updated
October 10, 2011
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00990366
Brief Title
Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve
Official Title
Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis results, study terminated 5/2010
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Obstruction, Cholangitis
Keywords
antireflux valve, biliary obstruction, cholangitis, biliary stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
biliary stent without an antireflux valve
Arm Type
Active Comparator
Arm Description
patients with biliary obstruction who need a biliary stent, selected for the stent without an antireflux valve arm
Arm Title
biliary stent with an antireflux valve
Arm Type
Active Comparator
Arm Description
patients with biliary obstruction, who need a biliary stent, selected for the stent with an antireflux valve arm
Intervention Type
Device
Intervention Name(s)
Cook´s biliary stent with an antireflux stent, normal biliary stent
Intervention Description
arms are assigned randomly by closed envelope method
Primary Outcome Measure Information:
Title
patency of a biliary stent
Time Frame
one year
Secondary Outcome Measure Information:
Title
Cholangitis
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina Salminen, MD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland

12. IPD Sharing Statement

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

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