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

Not Applicable

Completed

• Conditions: Biliary Obstruction; Hilar Cholangiocarcinoma
• Interventions: Device: ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)

• Registration Number: NCT04611100
• Lead Sponsor: Rajavithi Hospital

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

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-04
• Study Start: 2020-04-01
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-02
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency ablation	ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)	Patient receive endoscopic intraductal radiofrequency ablation before placement of biliary stent for obstructive jaundice

Primary Outcome Measures

Name	Time	Method
Biliary stent patency	up to 6 months	The duration between primary intervention and first recurrent increased in serum total bilirubin after intervention up to 6 months after the primary procedure

Secondary Outcome Measures

Name	Time	Method
Patient survival	up to 6 months	Survival time after primary intervention and documented patient death at 6 months after primary intervention

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand