NCT04611100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

March 4, 2020

Last Update Submit

March 22, 2022

Conditions

Hilar CholangiocarcinomaBiliary Obstruction

Keywords

Hilar cholangiocarcinomaBiliary obstructionRadiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 6 months

Secondary Outcomes (1)

  • Patient survival

    up to 6 months

Study Arms (2)

Conventional

NO INTERVENTION

Patient receive endoscopic placement of metallic biliary stent for obstructive jaundice

Radiofrequency ablation

EXPERIMENTAL

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

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

Interventions

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

Radiofrequency ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hilar cholangiocarcinoma diagnosed by imaging or pathology
  • Considered unresectable or unfit for surgery
  • Presence of obstructive jaundice need endoscopic biliary drainage

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, Thailand

Location

Related Publications (5)

  • Sripa B, Pairojkul C. Cholangiocarcinoma: lessons from Thailand. Curr Opin Gastroenterol. 2008 May;24(3):349-56. doi: 10.1097/MOG.0b013e3282fbf9b3.

    PMID: 18408464BACKGROUND

  • Doherty B, Nambudiri VE, Palmer WC. Update on the Diagnosis and Treatment of Cholangiocarcinoma. Curr Gastroenterol Rep. 2017 Jan;19(1):2. doi: 10.1007/s11894-017-0542-4.

    PMID: 28110453BACKGROUND

  • Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.

    PMID: 28130846BACKGROUND

  • Kim JH, Won HJ, Shin YM, Kim PN, Lee SG, Hwang S. Radiofrequency ablation for recurrent intrahepatic cholangiocarcinoma after curative resection. Eur J Radiol. 2011 Dec;80(3):e221-5. doi: 10.1016/j.ejrad.2010.09.019. Epub 2010 Oct 14.

    PMID: 20950977BACKGROUND

  • Razumilava N, Gores GJ. Cholangiocarcinoma. Lancet. 2014 Jun 21;383(9935):2168-79. doi: 10.1016/S0140-6736(13)61903-0. Epub 2014 Feb 26.

    PMID: 24581682BACKGROUND

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Tanyaporn Chantarojanasiri, MD

    Rajavithi hospital, Bangkok, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

November 2, 2020

Study Start

April 1, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

March 23, 2022

Record last verified: 2020-03

Locations

TH(1)