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Interim analysis results, study terminated 5/2010
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook´s biliary stent with an antireflux stent, normal biliary stent | Device | arms are assigned randomly by closed envelope method |
|
| Measure | Description | Time Frame |
|---|---|---|
| patency of a biliary stent | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Cholangitis | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulina Salminen, MD | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | 20520 | Finland |
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| ID | Term |
|---|---|
| D002761 | Cholangitis |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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