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

This study has been terminated.
(Interim analysis results, study terminated 5/2010)
Sponsor:
Information provided by (Responsible Party):
Hanna Vihervaara, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT00990366
First received: October 5, 2009
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Biliary Obstruction
Cholangitis
Device: Cook´s biliary stent with an antireflux stent, normal biliary stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • patency of a biliary stent [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cholangitis [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990366

Locations
Finland
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Paulina Salminen, MD Turku University Hospital
  More Information

No publications provided

Responsible Party: Hanna Vihervaara, Ph.D., Turku University Hospital
ClinicalTrials.gov Identifier: NCT00990366     History of Changes
Other Study ID Numbers: 58/180/2009
Study First Received: October 5, 2009
Last Updated: October 10, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by Turku University Hospital:
antireflux valve
biliary obstruction
cholangitis
biliary stent

Additional relevant MeSH terms:
Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014