Phase II study to evaluate the safety and efficacy of endoscopic radiofrequency ablation of the bile duct using the Habib Endo HPB catheter in patients with unresectable cholangiocarcinoma after biliary stent placement.

Phase II study to evaluate the safety and efficacy of endoscopic radiofrequency ablation of the bile duct using the Habib Endo HPB catheter in patients with unresectable cholangiocarcinoma after biliary stent placement. - Phase II study to evaluate the safety and efficacy of endoscopic radiofrequency ablation of the bile duct using the Habib Endo HPB catheter in patients with unresectable cholangiocarcinoma after biliary stent placement.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047127

Enrollment

Registered

2022-04-01

Start date

2025-03-31

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

Cholangiocarcinoma

Interventions

Perform one endoscopic radiofrequency ablation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients aged 20 years or older at enrollment (2) Patients diagnosed with cholangiocarcinoma (3) Patients requiring biliary drainage by ERCP and a plastic stent inserted at the first ERCP (4) Patients with obstructive jaundice with a serum total bilirubin (T-Bil) of 3 or higher before first ERCP (5) Clinical stage III or IV and not indicated for radical surgical treatment. (6) Performance status 0-2 (7) Any gender (8) On gemcitabine-based chemotherapy

Exclusion criteria

Exclusion criteria: (1) Patients in poor general condition who cannot undergo endoscopy (2) Patients taking more than 2 antiplatelet/anticoagulant drugs (3) Patients with a pacemaker implanted (4) Patients with a fever of 37.5 or higher and suspected cholangitis (5) Other patients deemed unsuitable for the procedure by the physician

Design outcomes

Primary

Measure	Time frame
All adverse events within 28 days after ERCP, including endoscopic RFA procedures	—

Secondary

Measure	Time frame
RFA procedure success rate, stent patency after RFA, and overall survival	—

Countries

Japan

Contacts

Public ContactSho Hasegawa

Yokohama City University Hospital Division of Endoscopy

t166064d@yokohama-cu.ac.jp045-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026