Efficacy of radiofrequency ablation in malignant hilar obstructio

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0003275
• Lead Sponsor: Soon Chun Hyang University Hospital Cheonan

Brief Summary

Purpose We aimed to evaluate the efficacy and safety of temperature-controlled intraductal radiofrequency ablation (ID-RFA) for advanced malignant hilar biliary obstruction (MHBO). Methods Patients were randomly assigned to RFA group (ID-RFA and bilateral plastic stent [PS]) or non-RFA group (bilateral PS) at a 1:1 ratio. Exchange to self-expanding metal stent (SEMS) was performed after 3 months or when premature PS occlusion occurred. Total event-free stent patency, overall survival (OS), and adverse events (AEs) were analyzed. Results A total of 30 patients from three hospitals were enrolled. Stent patency and OS did not differ between the two groups (178 days vs 122 days, P = .154; 230 days vs 144 days, P = .643; respectively). In patients with each stricture length =11 mm on both sides, stent patency was longer in the RFA group than in the non-RFA group (175 days vs 121 days, P = .028). More patients received elective exchange to SEMS without PS occlusion in the RFA group than in the non-RFA group (69.2% vs 23.1%, P = .018). AE rates did not differ between the two groups. Conclusions Temperature-controlled ID-RFA for advanced MHBO was safe and feasible. It could prevent premature PS occlusion within 3 months.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-11-30
• Results First Posted: 2021-11-20
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

?18 years and more
?Pathologically confirmed unresectable malignant hilar obstruction
?Malignant hilar obstruction due to cholangiocarcinoma or GB ca.
?Expected survival more than 3 months
?Performance status: ECOG 0~1 or Karnofsky performance >80%
?Consent to this study

Exclusion Criteria

?Contrast allergy
?Uncontrolled coagulopathy (PT-INR > 1.5; normal 0.85-1.25, platelet count < 60,000/mm3; normal 150,000-450,000/mm3)
?Can not stop the dual anti-platelet agent
?Uncompensated LC (Child Class C)
?ESRD
- Anatomical change due to surgery
?Inaccessible papilla due to failed cannulation or inaccess
?Pregnancy
- Poor performance status
?Disagree with this study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stent patency

Secondary Outcome Measures

Name	Time	Method
adverse event- cholangitis;survival