UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter randomized controlled trial of new-generation microwave ablation and radiofrequency ablation for hepatocellular carcinoma
Title of the study (Brief title)	A multicenter RCT of new-generation MWA and RFA for HCC
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the safety and the efficacy of new-generation microwave ablation and radiofrequency ablation for hepatocellular carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint is the technical success rate evaluated by the CT scan taken after the first session of new-generation microwave ablation or radiofrequency ablation The secondary endpoints are 1) complete ablation ratio of tumors after the final session of of new-generation microwave ablation or radiofrequency ablation, 2) the number of sessions until completion of the treatment, and adverse event ratio.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	radiofrequency ablation
Interventions/Control_2	new-generation microwave ablation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patient at the age of 20 to 100 when the informed consent was obtained 2. Patient with histopathologically confirmed carcinoma or tumors showing characteristic imaging features of hepatocellular carcinoma 3. Tumors were unresectable or patient declined surgery 4. Three or fewer tumors, each 3 cm or less in diameter, or a solitary lesion, 5 cm or less in diameter (Patients with both primary and recurrent tumors were included. Patients with local tumor progression were excluded) 5. No extrahepatic metastasis or vascular invasion 6. Patient with written informed consent
Key exclusion criteria	1. Patient with prothrombin activity of 50% or less. Patient with low platelet count that cannot be corrected by lusutrombopag or platelet transfusion 2. Patient with refractory ascites and at high risk of peritoneal bleeding 3. Patient with enterobiliary reflux 4. Contrast-enhanced CT cannot be performed because of renal dysfunction (creatinine of 2 mg/dL or more) or allergic adverse reactions to iodine contrast agents 5. Child-Pugh class C 6. ASA's (American Society of Anesthesiologists) physical score 3 or above 7. Patient who cannot accept necessary treatments, such as blood transfusion, because of religious reasons and others 8. Patient who cannot follow medical instructions because of dementia and others 9. Patient with tumors not visualized by ultrasonography or not accessible 10. Patient with adhesion between tumors and the gastrointestinal tract which may cause GI tract penetration or perforation 11.Patient with tumors adjacent to the major Glisson's capsule which may cause serious biliary injury or hepatic infarction 12.Patient not considered eligible to participate in this study by the attending doctor due to various reasons
Target sample size	210

Research contact person
Name of lead principal investigator	SHUICHIRO SHIINA
Organization	Juntendo University
Division name	Department of Gastroenterology
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	ivo@juntendo.ac.jp

Public contact
Name of contact person	SHUICHIRO SHIINA
Organization	Juntendo University
Division name	Department of Gastroenterology
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	ivo@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	順天堂大学大学院医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 26 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 01 Month 04 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039468