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Endoscopic Biliary RFA of Malignant Bile Duct Obstruction

NCT02582541 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-10-21

No results posted yet for this study

Summary

Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the duration of stent patency. RFA has showed promising results for malignant bile duct obstruction and increasing the duration of stent patency. The aim of our study was to evaluate the feasibility and safety of endoscopic RFA for the treatment of bile duct obstructions, and to compare the efficacy of Endoscopic biliary RFA with the addition of self-expanding metal stents (SEMS) to SEMS alone in a randomized controlled trial.

Conditions

Interventions

PROCEDURE

SEMS alone

The SEMS (Wallstent, Boston Scientific, USA) would be placed.

PROCEDURE

SEMS plus radiofrequency ablation

The RFA catheter has an 8 F bipolar probe and two ring electrodes 8 mm apart with the distal electrode 5 mm from the leading edge, providing local coagulative necrosis over a 2.5 cm length. The catheter is compatible with standard side-viewing endoscopes (3.2 mm working channel), and could be passed over 0.035 inch guidewires. Ablation was performed by using an RFA generator (1500 RF generator; RITA Medical Systems, Fremont, Calif) delivering electrical energy at 400 kHz set at 7-10 W for 90-120 seconds. The RFA energy can be delivered repetitively at different tumor sites within one procedure. After the RFA application is completed, SEMS (Wallstent, Boston Scientific, USA) can be deployed.

Sponsors & Collaborators

  • The Second Hospital of Nanjing Medical University

    lead OTHER

Principal Investigators

  • Lin Miao, MD · Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-10-31
Completion
2018-11-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582541 on ClinicalTrials.gov