Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma

Study Overview
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Brief Summary
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The study aim to evaluate the efficacy of intraductal radiofrequency ablation for unresetable hilar cholangiocarcinoma in addition to biliary stenting. The patient would be randomized into 1:1 ratio of conventional group who received biliary stenting alone, and RFA group who receive intraductal RFA before biliary stenting. Immediate complications as well as long term stent patency and patient survival would be studied.

Detailed Description
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Study design: randomized single-blind control trial Study population: patient with unresectable hilar cholangiocarcinoma with obstructive jaundice who need hilar biliary stenting Primary endpoint: Biliary stent patency time Secondary endpoint: Patient survival Intervention Recruited patients randomly assigned into 2 groups, conventional and RFA group by sealed enveloped All patients receive endoscopic biliary stenting. Those in RFA group receive RFA before biliary stent. Monitor for adverse event during hospitalization and during follow up Follow up as outpatient in 4-weekly interval with monitoring of serum liver function test as routine

Official Title
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Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma

Conditions
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Hilar Cholangiocarcinoma, Biliary Obstruction

Intervention / Treatment
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* Device: ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hilar cholangiocarcinoma diagnosed by imaging or pathology Considered unresectable or unfit for surgery Presence of obstructive jaundice need endoscopic biliary drainage Exclusion Criteria: History of unremovable metallic biliary stent placement severe biliary stricture that the instrument was unable to pass through unfit for endoscopic under conscious sedation loss to follow up and loss contact within 6 months after intervention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional<br>Patient receive endoscopic placement of metallic biliary stent for obstructive jaundice | |
| Experimental: Radiofrequency ablation<br>Patient receive endoscopic intraductal radiofrequency ablation before placement of biliary stent for obstructive jaundice | Device: ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)<br>* Intraductal radiofrequency ablation using ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) 10W 2 minutes at the obstructed bile duct before placing uncover self-expandable biliary metal stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biliary stent patency | The duration between primary intervention and first recurrent increased in serum total bilirubin after intervention up to 6 months after the primary procedure | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival | Survival time after primary intervention and documented patient death at 6 months after primary intervention | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hilar cholangiocarcinoma, Biliary obstruction, Radiofrequency ablation