NCT00990366

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

1.1 years

First QC Date

October 5, 2009

Last Update Submit

October 10, 2011

Conditions

Biliary ObstructionCholangitis

Keywords

antireflux valvebiliary obstructioncholangitisbiliary stent

Outcome Measures

Primary Outcomes (1)

  • patency of a biliary stent

    one year

Secondary Outcomes (1)

  • Cholangitis

    one year

Study Arms (2)

biliary stent without an antireflux valve

ACTIVE COMPARATOR

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

biliary stent with an antireflux valve

ACTIVE COMPARATOR

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

Interventions

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

arms are assigned randomly by closed envelope method

biliary stent with an antireflux valvebiliary stent without an antireflux valve

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Cholangitis

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Paulina Salminen, MD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 6, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

FI(1)