Covered or Uncovered Bile Duct Stents
- Conditions
- Bile Duct Neoplasms
- Interventions
- Device: covered or uncovered stents
- Registration Number
- NCT01232101
- Lead Sponsor
- Göteborg University
- Brief Summary
The study is investigator initiated. Tumors that gives the narrowing of the bile ducts prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk of bacterial growth in bile with severe infections as a result. Unresectable bile duct strictures have routinely been treated them with plastic stents. The plastic stents have been replaced by self expandable metallic stents.
These stents remain open longer for reasons that they have a larger diameter so that the bile flows through more easily. One problem with these stents, however, is that the tumor growing through the wire mesh which forms the wall of the stent. This has led to the development of so-called covered stents. Whether covered stents have longer patency is unclear as well as whether they are as safe. There is reason to believe that covered stents remain open longer, but there may be an increased risk of migration and other complications.
The purpose is to prospectively and randomized compare the two stent types. The study endpoint is the clogging of the stent or the patient's death. We also monitor complications, regress time of the jaundice and success rate of stent placement
- Detailed Description
0
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- Patients with unresectable, distal bile duct stricture needing relieved endoscopically
- Expected survival greater than 3 months
- The patient must give written consent to participate in the study
- Stricture close to hilus
- Need for interpreter
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description covered self expandable metallic stents covered or uncovered stents Patients with bile malignant bile duct strictures are randomized to covered or uncovered stent Uncovered self expandable metallic stent covered or uncovered stents -
- Primary Outcome Measures
Name Time Method The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMS Stent occlusion or patient death
- Secondary Outcome Measures
Name Time Method Secondary objectives were to study difference in technical success, efficacy of drainage and complication rate between covered and uncovered metal stents Evaluated within three days
Trial Locations
- Locations (1)
Kjell-Arne Ung, Dpt of Internal Medicine, Karnsjukhuset,
🇸🇪Skovde, Sweden