EUS-guided choledocho-duodenostomy versus ERCP with covered metallic stents in patients with unresectable malignant distal common bile duct strictures: a multi-center randomized controlled trial
- Conditions
- unresectable distal CBD malignancyFCSEMSunresectable,distal CBD,EUS,ERCP,
- Registration Number
- TCTR20181001002
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
1. Consecutive patients aged ≥ 18 years old admitted for obstructive jaundice due to unresectable distal CBD malignancy
2. Eligible for endoscopic intervention
3. Written informed consent
1. Multiple hepatic metastases involving >30% of the liver parenchyma
2. Presence of main portal vein thrombosis
3. Locally advanced malignancy scheduled for neoadjuvant chemotherapy or radiotherapy
4. Extensive tumor involvement of the 1st part of duodenum resulting in tissue thickness between the bile duct and duodenum of ≥ 8mm
5. Prior SEMS placement
6. Intraductal papillary
mucinous carcinomas
7. Prior Billroth II or roux-en Y reconstruction
8. Bleeding disorder or use of anticoagulation
9. Child’s B/C cirrhosis
10. Pregnancy
11. Performance status ECOG ≥3 (
12. Presence of other malignancy
13. Life expectancy < 3months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 6-months patency rate of covered metallic stent used during EUS-guided choleduodenostomy versus ERCP 6 months 6-months patency rate
- Secondary Outcome Measures
Name Time Method Technical success rate of EUS-guided choledochoduodenostomy versus ERCP with FCSEMS Immediately Ability to access and drain the CBD with placement of fully covered metallic stent,Clinical success rate of EUS-guided choledochoduodenostomy versus ERCP with FCSEMS 7 days >30% drop in bilirubin