Spots Global Cancer Trial Database for Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma

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Trial Identification

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

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

Study ID: NCT04611100

Conditions

Hilar Cholangiocarcinoma

Biliary Obstruction

Interventions

ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)

Study Description

Brief Summary: 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: 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 1. Recruited patients randomly assigned into 2 groups, conventional and RFA group by sealed enveloped 2. All patients receive endoscopic biliary stenting. Those in RFA group receive RFA before biliary stent. 3. Monitor for adverse event during hospitalization and during follow up 4. Follow up as outpatient in 4-weekly interval with monitoring of serum liver function test as routine