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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-12-30

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.

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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

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

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Hilar Cholangiocarcinoma Biliary Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional

Patient receive endoscopic placement of metallic biliary stent for obstructive jaundice

Group Type NO_INTERVENTION

No interventions assigned to this group

Radiofrequency ablation

Patient receive endoscopic intraductal radiofrequency ablation before placement of biliary stent for obstructive jaundice

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No