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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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20181001002
Enrollment
10
Registered
2018-10-01
Start date
2018-08-30
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable distal CBD malignancy unresectable&#44

Interventions

Insertion of a fully covered metallic stent using EUS&#45
guided choledochoduodenostomy,Insertion of a fully covered metallic stent using ERCP
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
EUS&#45
guided Choledochoduodenostomy with fully covered metallix stent,ERCP with fully covered metallic stent

Sponsors

Chinese University of Hong Kong
Lead Sponsor
Chulalongkorn University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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&#45;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

Design outcomes

Primary

MeasureTime frame
6&#45;months patency rate of covered metallic stent used during EUS&#45;guided choleduodenostomy versus ERCP 6 months 6&#45;months patency rate—

Secondary

MeasureTime frame
Technical success rate of EUS&#45;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&#45;guided choledochoduodenostomy versus ERCP with FCSEMS 7 days >30% drop in bilirubin—

Countries

Thailand

Contacts

Public ContactPradermchai Kongkam

King Chulalongkorn Memorial Hospital

kongkam@hotmail.com0805575111

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026