Efficacy of Multihole Self-expandable Metal Stent For Palliative Treatment of Malignant Distal Biliary Stricture
Phase 3
Recruiting
- Conditions
- - Patients with malignant bile duct obstruction- Time of stent patency to relieve bile duct obstruction- Success rate of biliary bypass for each type of stent- Complications after stent insertioDistal biliary obstructionERCPStentFully-cover self-expandable metal stent
- Registration Number
- TCTR20200819002
- Lead Sponsor
- MI Tech Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 156
Inclusion Criteria
1.Age more than 18 years
2.Clinical obstructive jaundice from potentially unresectable malignant distal biliary stricture diagnosed by CT or MRI or ERCP with or without cyto-pathological confirmation
3.Upper margin of the stricture is located below hilar at least 10 mm
4.No prior biliary drainage by other methods
Exclusion Criteria
Exclusion criteria
1.Pregnancy
2.Contraindications for ERCP
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrent biliary obstruction (event) From stent insertion until event occur or patients death Time to recurrent biliary obstruction
- Secondary Outcome Measures
Name Time Method Clinical success rate 2 weeks after stent insertion Rate of successful biliary bypass in each group,Complications From stent insertion Rate of post ERCP complications; pancreatitis, cholecystitis, cholangitis, and bleeding,Etiology of recurrent biliary obstruction From stent insertion to clinically detected recurrent obstructive jaundice Same as outcome name