Multi-Hole Self-expandable Metal Stent (MHSEMS) versus Fully-covered Self-Expandable Metal Stent (FCSEMS) for Distal Biliary Stricture: A Multicenter Prospective Randomized Controlled Trial
Phase 1
Recruiting
- Conditions
- Hilar ObstructionCholangiocarcinomaMigration rate of metallic stentsComplication rate of metallic stentsRecurrence of Biliary Obstruction while on stent
- Registration Number
- TCTR20180716005
- Lead Sponsor
- Faculty of Medicine King Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. Over 18 years
2. Patients who have been diagnosed with cholangiocarcinoma with or without histopathology
3. The upper extremity of the bile duct obstruction is at least 1 centimeter below the bile duct at the hilar (hilar).
4. The patient has never had a catheter drainage by any other means.
Exclusion Criteria
1. Platelet count <50,000 / ml or international normalized ratio> 1.5
2. Get anti-coagulant medication.
3. Pregnancy
4. Prohibited or unable to perform endoscopic cholecystectomy.
5. There is blockage of hilum.
6. It is not possible to insert a biliary catheter
7. Follow-up and Diagnosis Results After Non-Hodgkin's Disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrent Biliary Obstruction Rate of Multi-hole Metallic Stents versus Fully Covered Metallic Stent after insertion of stent recurrent biliary Obstruction Rate
- Secondary Outcome Measures
Name Time Method Technical and clinical success rate of MHSEMS vs FCSEMS after insertion of stent migration rate