Clinical trial NCT04611100: Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
Official title: Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hilar Cholangiocarcinoma
Biliary Obstruction
Keywords: Hilar cholangiocarcinoma
Biliary obstruction
Radiofrequency ablation
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2020-11-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Biliary stent patency
timeFrame: up to 6 months
Secondary outcomes:
measure: Patient survival
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
affiliation: Rajavithi hospital, Bangkok, Thailand
name: Tanyaporn Chantarojanasiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sripa B, Pairojkul C. Cholangiocarcinoma: lessons from Thailand. Curr Opin Gastroenterol. 2008 May;24(3):349-56. doi: 10.1097/MOG.0b013e3282fbf9b3.
citation: 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.
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. No abstract available.
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.
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.