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

Study Overview
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Brief Summary
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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.

Conditions
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Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer

Intervention / Treatment
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* Device: Radiofrequency ablation with stenting
* Device: stenting


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA with RF catheter (ELRA®) with stenting<br> | Device: Radiofrequency ablation with stenting<br>* Side viewing endoscope or PTCS scope can be used for all procedures. Cholangiogram is performed to confirm the stricture location, length and diameter. And then, RF catheter (ELRA®) is advanced over a guide wire at the level of the biliary stricture and ablation at 7-10 watts for a time period of 60-120s according to the length is conducted. After performance of RFA, metal stents are inserted to ensure adequate decompression and bile drainage.<br>|
| Active Comparator: stenting<br> | Device: stenting<br>* Metal stents are inserted to ensure adequate decompression and bile drainage. The diameter and stent lengths can be changed according to the lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of metal stent | Patency of metal stent (From stent insertion date to stent occlusion date or last follow up date if stent is patent) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 12 months | 
| Complication rate |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiocarcinoma, radiofrequency ablation, metal stent