NCT04611100

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hilar Cholangiocarcinoma
• Biliary Obstruction

Interventions

Type	Name	Description
DEVICE	ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)	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

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2020-11-02
• Last updated: 2022-03-23

Locations

1 site across 1 country: Thailand