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

Turku University Hospital (TYKS)

Status: Terminated

Conditions: Cholangitis; Biliary Obstruction

Treatments: Device: Cook´s biliary stent with an antireflux stent, normal biliary stent

Study type: Interventional

Funder types: Other

Identifiers

NCT00990366

58/180/2009

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

biliary stent without an antireflux valve

Active Comparator group

Description:

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

Treatment:

Device: Cook´s biliary stent with an antireflux stent, normal biliary stent

biliary stent with an antireflux valve

Active Comparator group

Description:

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

Treatment:

Device: Cook´s biliary stent with an antireflux stent, normal biliary stent