Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
Primary Purpose
Hilar Cholangiocarcinoma, Biliary Obstruction
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)
Sponsored by
About this trial
This is an interventional treatment trial for Hilar Cholangiocarcinoma focused on measuring Hilar cholangiocarcinoma, Biliary obstruction, Radiofrequency ablation
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
Sites / Locations
- Rajavithi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional
Radiofrequency ablation
Arm Description
Patient receive endoscopic placement of metallic biliary stent for obstructive jaundice
Patient receive endoscopic intraductal radiofrequency ablation before placement of biliary stent for obstructive jaundice
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Patient survival
Survival time after primary intervention and documented patient death at 6 months after primary intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04611100
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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
Recruited patients randomly assigned into 2 groups, conventional and RFA group by sealed enveloped
All patients receive endoscopic biliary stenting. Those in RFA group receive RFA before biliary stent.
Monitor for adverse event during hospitalization and during follow up
Follow up as outpatient in 4-weekly interval with monitoring of serum liver function test as routine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hilar Cholangiocarcinoma, Biliary Obstruction
Keywords
Hilar cholangiocarcinoma, Biliary obstruction, Radiofrequency ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional
Arm Type
No Intervention
Arm Description
Patient receive endoscopic placement of metallic biliary stent for obstructive jaundice
Arm Title
Radiofrequency ablation
Arm Type
Experimental
Arm Description
Patient receive endoscopic intraductal radiofrequency ablation before placement of biliary stent for obstructive jaundice
Intervention Type
Device
Intervention Name(s)
ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)
Intervention Description
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
Primary Outcome Measure Information:
Title
Biliary stent patency
Description
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 Outcome Measure Information:
Title
Patient survival
Description
Survival time after primary intervention and documented patient death at 6 months after primary intervention
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanyaporn Chantarojanasiri, MD
Organizational Affiliation
Rajavithi hospital, Bangkok, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
18408464
Citation
Sripa B, Pairojkul C. Cholangiocarcinoma: lessons from Thailand. Curr Opin Gastroenterol. 2008 May;24(3):349-56. doi: 10.1097/MOG.0b013e3282fbf9b3.
Results Reference
background
PubMed Identifier
28110453
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.
Results Reference
background
PubMed Identifier
28130846
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.
Results Reference
background
PubMed Identifier
20950977
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.
Results Reference
background
PubMed Identifier
24581682
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.
Results Reference
background
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Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
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