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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
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
Rajavithi Hospital
Bangkok, Thailand
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
Time frame: up to 6 months
Patient survival
Survival time after primary intervention and documented patient death at 6 months after primary intervention
Time frame: up to 6 months
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