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

March 22, 2022 updated by: Rajavithi Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Rajavithi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional
Patient receive endoscopic placement of metallic biliary stent for obstructive jaundice
Experimental: Radiofrequency ablation
Patient receive endoscopic intraductal radiofrequency ablation before placement of biliary stent for obstructive jaundice
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biliary stent patency
Time Frame: 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
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient survival
Time Frame: up to 6 months
Survival time after primary intervention and documented patient death at 6 months after primary intervention
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Investigators

  • Principal Investigator: Tanyaporn Chantarojanasiri, MD, Rajavithi hospital, Bangkok, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

October 30, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111/2562

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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