Skip to main content
OpenTrials
Completed

NCT Number: NCT04611100

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hilar Cholangiocarcinoma Adenocarcinoma Biliary Obstruction Carcinoma Cholangiocarcinoma Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital

Bangkok, Thailand

About this study

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

  • Recruited patients randomly assigned into 2 groups, conventional and RFA group by sealed enveloped
  • All patients receive endoscopic biliary stenting. Those in RFA group receive RFA before biliary stent.
  • Monitor for adverse event during hospitalization and during follow up
  • Follow up as outpatient in 4-weekly interval with monitoring of serum liver function test as routine

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Patient survival

    Time frame: up to 6 months

    Survival time after primary intervention and documented patient death at 6 months after primary intervention

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2020
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.