Efficacy and Safety of Endobiliary Radiofrequency Ablation by Using a Novel RF Catheter (ELRA®) on Maintaining the Patency of Endobiliary Metal Drainage in Patients With Malignant Biliary Strictures : A Double-arm Comparable Study

Not Applicable

• Conditions: Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer
• Interventions: Device: stenting; Device: Radiofrequency ablation with stenting

• Registration Number: NCT02646514
• Lead Sponsor: Yonsei University

Brief Summary

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, gallbladder cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. When compared to plastic stents, SEMS present a significantly decreased risk of recurrent biliary obstruction. SEMS are also more cost-effective than plastic stents in patients with a life expectancy of longer than 4 months. However, despite their numerous benefits, SEMS become occluded in up to 50 % of patients in the first 6-8 months.

Radiofrequency ablation (RFA) has been used to treat malignancies of the liver since the early 1990s. Other studies have investigated its role in diseases of the colon and esophagus. More recently, this technique has been recognized for its potential in palliative treatment of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased benign epithelial hyperplasia and tumor ingrowth. However, RFA along with placement of SEMS has not been well studied. On the other hand, newly developed RFA catheter (ELRA®) showed the feasibility and safety in south korea, recently.

The purpose of this study was to investigate the Efficacy and safety of endobiliary RFA by using a novel RF catheter (ELRA®) on maintaining the patency of endobiliary metal drainage in patients with malignant biliary strictures.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-28
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Pathologically confirmed malignant biliary obstruction or clinically defined malignant biliary obstruction
• older than 19 years old
• Life expectancy > 3 months
• Inoperable case due to advanced stage or comorbidity
• Informed consent

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Exclusion Criteria

• Inadequate case for ERCP
• Inadequate coagulation (platelet count < 60,000/µl, PT(INR)>1.5)
• Abnormal biliary tract system due to previous operation
• Failed endoscopic approach to duodenum or biliary tract
• Pregnancy
• No signed informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stenting	stenting	-
RFA with RF catheter (ELRA®) with stenting	Radiofrequency ablation with stenting	-

Primary Outcome Measures

Name	Time	Method
Patency of metal stent	12 months	Patency of metal stent (From stent insertion date to stent occlusion date or last follow up date if stent is patent)

Secondary Outcome Measures

Name	Time	Method
Overall Survival	12 months
Complication rate	12 months

Trial Locations

Locations (1)

Severance Hospital, Yonsei University; 🇰🇷 Seoul, Korea, Republic of