Exploratory survey of the safety and efficacy of endoscopic radiofrequency ablation for malignant biliary stricture

Phase 2

• Conditions: Malignant biliary stricture

• Registration Number: JPRN-UMIN000031601
• Lead Sponsor: Graduate School of Medicine, Chiba University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-12
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with malignant biliary stricture due to lymph node metastasis 2) Patient with pacemaker or defibrillator inserted 3) Patients who are unlikely to have a prognosis for 1 month 4) Patients with performance status 2 or higher 5) Patients who can not control bleeding tendency (PTINR 1.5 or more, platelet number 50,000 or less). 6) Patients with duodenal stenosis, obstruction that may affect biliary excretion 7) Patients who are pregnant, have a possibility of pregnancy, are within 28 days after birth, or who are breastfeeding 8) Patients with history of upper gastrointestinal surgical resection 9) Patients who have impaired renal function and can not perform contrast CT 10) Patients in which a bile duct metal stent has already been placed

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious adverse event incidence

Secondary Outcome Measures

Name	Time	Method
Procedure completion rate Evaluation of malignant biliary stricture diameter and stenosis length in retrograde cholangiography (before and after treatment) Evaluation of cauterization range using Dynamic CT Biliary stent patent term Overall survival Adverse event incidence (post-bleeding rate, cholangitis incidence rate, pancreatitis incidence rate, fever incidence rate, abdominal pain incidence rate)