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

Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00990366
• Other study ID #: 58/180/2009
• Status: Terminated
• Phase: N/A
• First received: October 5, 2009
• Last updated: October 10, 2011
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: October 2011
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Obstruction
• Cholangitis

Intervention

Device:
• Cook´s biliary stent with an antireflux stent, normal biliary stent
arms are assigned randomly by closed envelope method

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patency of a biliary stent		one year	Yes
Secondary	Cholangitis		one year	Yes