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ERCP with covered metallic stents versus EUS-guided hepaticogastrostomy for unresectable distal Malignant Biliary Obstruction (RUMBO): A prospective randomized controlled trial

ERCP with covered metallic stents versus EUS-guided hepaticogastrostomy for unresectable distal Malignant Biliary Obstruction (RUMBO): A prospective randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20240601003
Enrollment
80
Registered
2024-06-01
Start date
2025-01-02
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

Patients with unresectable cancer causing distal bile duct obstruction requiring, suitable for and would undergo endoscopic biliary drainage. EUS-guided hepaticogastrostomy (EUS-HGS), endoscopic retrograde cholangiopancreatography (ERCP), malignant distal biliary obstruction (MDBO)

Interventions

biliary obstruction (RBO) rate between the ERCP and the EUS-HGS in patients with cancer having distal bile duct obstruction,biliary obstruction (RBO) rate between the ERCP and the EUS-HGS in patients
Supportive Care,Supportive Care
1biliary obstruction (RBO) rate between the ERCP and the EUS-HGS in patients with cancer having distal bile duct obstruction,2 biliary obstruction (RBO) rate between the ERCP and the EUS-HGS in patien

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with unresectable cancer causing distal bile duct obstruction requiring, suitable for and would undergo endoscopic biliary drainage. Patients in a reasonably good physical condition (ECOG2). Patients with life expectancy longer than 6 months. Patients with viable liver volume more than 80%. Patients without preceding hepatectomy or atrophic liver. Patients without cirrhosis child B or C. Patients without significant ascites that might preclude EUS-HGS.

Exclusion criteria

Exclusion criteria: Exclusion criteria Patients with hilar bile duct obstruction. Patients with abnormal blood clotting or platelet function that cannot be corrected (INR < 1.5 or platelet count <50,000). Pregnant patients.

Design outcomes

Primary

MeasureTime frame
The difference in the 6-month RBO rate between the self-expanding metal stent placed to treat bile duct obstruction due to cancer using ERCP technique and the EUS-HGS technique at 6 months after end of the intervention EUS-guided hepaticogastrostomy (EUS-HGS), endoscopic retrograde cholangiopancreatography (ERCP)

Secondary

MeasureTime frame
The differences in the technical success rate, clinical success rate, survival rate, patency time, quality of life, and incidence of adverse events at 6 months after end of the intervention EUS-guided hepaticogastrostomy (EUS-HGS), endoscopic retrograde cholangiopancreatography (ERCP)

Countries

Thailand

Contacts

Public Contactpradermchai kongkam

Chulalongkorn University

kongkam@hotmail.com022564000

Outcome results

None listed

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