A multicenter prospective study on the efficacy of endoscopic ultrasound-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS) for unresectable malignant biliary obstruction

A multicenter prospective study on the efficacy of endoscopic ultrasound-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS) for unresectable malignant biliary obstruction - A multicenter prospective study on the efficacy of endoscopic ultrasound-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS)

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059659

Enrollment

Registered

2025-11-06

Start date

2023-01-27

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Patients with unresectable malignant biliary obstruction for whom transpapillary treatment is difficult, necessitating EUS-BD, in whom EUS-AS+HGS is attempted.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with unresectable advanced malignant tumors. 2. Patients with obstructive jaundice due to malignant tumors requiring biliary drainage. 3. Patients in whom ERCP-guided biliary drainage is not feasible or has failed. 4. Patients with obstructive jaundice due to malignant tumors who undergo EUS-AS+HGS as the biliary drainage procedure. 5. Patients in whom intrahepatic bile duct dilatation is confirmed by ultrasonography, CT, or other imaging modalities. 6. Patients aged 20 years or older at the time of consent.

Exclusion criteria

Exclusion criteria: 1. Patients in whom endoscopic approach is not feasible. 2. Patients with a performance status of 4. 3. Patients with severe comorbidities involving other organs. 4. Patients who are unable to provide informed consent. 5. Any other patients deemed inappropriate for inclusion in the study by the principal or sub-investigator.

Design outcomes

Primary

Measure	Time frame
Time to recurrent biliary obstruction (TRBO) and its comparison with historical data	—

Secondary

Measure	Time frame
1. Technical success rate 2. Clinical success rate 3. Adverse event rate 4. Length of hospital stay 5. Overall survival	—

Countries

Japan

Contacts

Public ContactMasahiro Itonaga

Wakayama Medical University Second Department of Internal Medicine

itonaga@wakayama-med.ac.jp073-447-2300

Outcome results