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Endobiliary Radiofrequency Ablation Using a New Catheter for Malignant Biliary Strictures: A Prospective Multicenter Study

Endobiliary Radiofrequency Ablation Using a New Catheter for Malignant Biliary Strictures: A Prospective Multicenter Study - Endobiliary radiofrequency ablation for malignant biliary strictures

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025847
Enrollment
100
Registered
2017-01-25
Start date
2016-03-10
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

Malignant biliary strictures by bile duct cancer, gallbladder cancer, or pancreatic cancer

Interventions

Endobiliary radiofrequency ablation by using a new catheter and biliary metallic stenting through ERCP

Sponsors

Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) More than 19 in age 2) Extrahepatic malignant biliary stricture that was histophathologically or clinically confirmed 3)Unresectable or inoperable due to comorbidity or refusal of operation 4) More than 3 months of predictive survival

Exclusion criteria

Exclusion criteria: 1) Contraindications for ERCP 2) Uncontrolled coagulopathy: PT-INR > 1.5 (normal 0.85 - 1.25) or platelet count < 60,000/mm3 (normal 150,000 - 450,000/mm3) 3) Previously operation of bile duct 4) Impossible to access to the ampulla of Vater or failed selective biliary cannulation 5) Pregnant or breastfeeding women 6) Refusal to the study

Design outcomes

Primary

MeasureTime frame
The incidence of early adverse events within 30 days after endobiliary radiofrequency such as hemobilia, bile duct perforation, pancreatitis, bleeding, cholangitis, perforation, or cholecystitis.

Secondary

MeasureTime frame
Late adverse events after 30 days after endobiliary radiofrequency, stent patency of biliary metallic stent after endobiliary radiofrequency ablation, and patient survival after endobiliary radiofrequncy ablation.

Countries

Asia(except Japan)

Contacts

Public ContactHyun Jong Choi

SoonChunHyang University School of Medicine Digestive Disease Center and Research Institute, Department of Internal Medicine

joseph@schmc.ac.kr+82-32-621-5211

Outcome results

None listed

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