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CompletedNCT04611100Updated Mar 23, 2022

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

An interventional study of ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) in Hilar Cholangiocarcinoma and Biliary Obstruction, sponsored by Rajavithi Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-23.

Sponsored by Rajavithi Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Hilar Cholangiocarcinoma
  • Biliary Obstruction

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Keywords

  • Hilar cholangiocarcinoma
  • Biliary obstruction
  • Radiofrequency ablation
03

In context

Klatskin Tumor

82 studies on the registry are indexed under Klatskin Tumor; 27 are open to participants now.

This study's enrollment of 70 is above the median of 55 across 56 interventional studies indexed under Klatskin Tumor.

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Lead sponsor

Rajavithi Hospital is the lead sponsor of 46 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (actual)

Study arms

  • 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)

Interventions

  • DeviceELRA 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

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What researchers measure

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

    Time frame: up to 6 months

Secondary outcomes

  1. Patient survival

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

    Time frame: up to 6 months

07

Study locations

1 site
  • Rajavithi Hospital
    Bangkok, Thailand
08

References and documents

Publications

  • Sripa B, Pairojkul C. Cholangiocarcinoma: lessons from Thailand. Curr Opin Gastroenterol. 2008 May;24(3):349-56. doi: 10.1097/MOG.0b013e3282fbf9b3. PubMed 18408464 ↗
  • 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. PubMed 28110453 ↗
  • 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. PubMed 28130846 ↗
  • 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. PubMed 20950977 ↗
  • 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. PubMed 24581682 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04611100
Lead sponsor
Rajavithi Hospital
Responsible party
Sponsor
First posted
Nov 2, 2020
Start date
Apr 1, 2020
Primary completion
Dec 30, 2021
Completion
Dec 30, 2021
Last update
Mar 23, 2022

Study contacts

Tanyaporn Chantarojanasiri, MD
principal investigator · Rajavithi hospital, Bangkok, Thailand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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