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Endoscopic retrograde cholangiopancreatography with plastic stents versus Endoscopic ultrasound-guided hepaticogastrostomy for unresectable distal Malignant Biliary Obstruction (RUMBO): A prospective randomized controlled trial

Endoscopic retrograde cholangiopancreatography with plastic stents versus Endoscopic ultrasound-guided hepaticogastrostomy for unresectable distal Malignant Biliary Obstruction (RUMBO): A prospective randomized controlled trial

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241203002
Enrollment
80
Registered
2024-12-03
Start date
2025-02-18
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

it more difficult for patients to schedule follow-up appointments and receive treatment. However, it is essential for these cancer patients to continuously seek care at hospitals. Biliary drainage is necessary to administer chemotherapy and help alleviate discomfort from obstructive bile duct conditions. EUS-guided hepaticogastrostomy (EUS-HGS), endoscopic retrograde cholangiopancreatography (ERCP), malignant distal biliary obstruction (MDBO)

Interventions

Endoscopic Retrograde CholangioPancreatography (ERCP) to place a stent through the narrowed area. This is because ERCP has been studied more extensively. Endoscopic ultrasonography-guided biliary drai
Experimental Procedure/Surgery,Experimental Procedure/Surgery
endoscopic retrograde cholangiopancreatography (ERCP),EUS-guided hepaticogastrostomy (EUS-HGS)

Sponsors

Center of Excellence for Innovation and Endoscopy in Gastrointestinal Oncology, Division of Gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-75 years who have signed the informed consent form to participate in the research. 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 (ECOG less than 2). 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: 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
Recurrent biliary obstruction (RBO) 6 months Quality of life (EORTC QLQ-30)

Secondary

MeasureTime frame
Technical success: 6 months Quality of life (EORTC QLQ-30),Clinical success 6 months Quality of life (EORTC QLQ-30),Clinical success 6 month Quality of life (EORTC QLQ-30)

Countries

Thailand

Contacts

Public ContactPradermchai Kongkam

Faculty of Medicine, Chulalongkorn University

kongkam@hotmail.com022564356

Outcome results

None listed

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