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

• Sponsor: Rajavithi Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04611100
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 21
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hilar Cholangiocarcinoma; Biliary Obstruction	Device: ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
• Actual Study Start Date: Apr 1, 2020
• Actual Primary Completion Date: Dec 30, 2021
• Actual Study Completion Date: Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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); 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

Outcome Measures

Primary Outcome Measures

1. Biliary stent patency [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 Outcome Measures

1. Patient survival [up to 6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rajavithi Hospital	Bangkok		Thailand

Sponsors and Collaborators

• Rajavithi Hospital

Investigators

• Principal Investigator: Tanyaporn Chantarojanasiri, MD, Rajavithi hospital, Bangkok, Thailand

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Rajavithi Hospital
• ClinicalTrials.gov Identifier: NCT04611100
• Other Study ID Numbers: 111/2562
• First Posted: Nov 2, 2020
• Last Update Posted: Mar 23, 2022
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Rajavithi Hospital: Hilar cholangiocarcinoma; Biliary obstruction; Radiofrequency ablation
• Additional relevant MeSH terms: Cholangiocarcinoma; Klatskin Tumor

Study Results

No Results Posted as of Mar 23, 2022