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NCT04611100 Clinical Trial

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

Biliary Obstruction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04611100
Other study ID # 111/2562
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date December 30, 2021

Study information
Verified date March 2020
Source Rajavithi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Thailand Rajavithi Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Patient survival Survival time after primary intervention and documented patient death at 6 months after primary intervention up to 6 months
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