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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036206
Receipt No. R000041237
Scientific Title The safety and efficacy of microwave ablation and radiofrequency ablation for colorectal cancer liver metastasis : A randomized controlled clinical trial
Date of disclosure of the study information 2019/03/15
Last modified on 2019/03/15

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Basic information
Public title The safety and efficacy of microwave ablation and radiofrequency ablation for colorectal cancer liver metastasis : A randomized controlled clinical trial
Acronym The safety and efficacy of microwave ablation and radiofrequency ablation for colorectal cancer liver metastasis : A randomized controlled clinical trial
Scientific Title The safety and efficacy of microwave ablation and radiofrequency ablation for colorectal cancer liver metastasis : A randomized controlled clinical trial
Scientific Title:Acronym The safety and efficacy of microwave ablation and radiofrequency ablation for colorectal cancer liver metastasis : A randomized controlled clinical trial
Region
Japan

Condition
Condition Colorectal liver metastasis
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the safety and the efficacy of microwave ablation and radiofrequency ablation for colorectal liver metastasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint is the Modified RECIST evaluated by the CT scan taken after the first session of microwave ablation or radiofrequency ablation.
Key secondary outcomes 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.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Microwave ablation
Interventions/Control_2 Radiofrequency 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 colorectal cancer liver metastasis
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 platelet of 50,000/mm3 or less. Patient with PT of 50% or less.
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. ASA's (American Society of Anesthesiologists) physical score 3 or above
6. Patient who cannot accept necessary treatments, such as blood transfusion, because of religious reasons and others
7. Patient who cannot follow medical instructions because of dementia and others
8. Patient with tumors not visualized by ultrasonography or not accessible
9. Patient with adhesion between tumors and the gastrointestinal tract which may cause GI tract penetration or perforation
10.Patient with tumors adjacent to the major Glisson's capsule which may cause serious biliary injury or hepatic infarction
11.Patient not considered eligible to participate in this study by the attending doctor due to various reasons
Target sample size 104

Research contact person
Name of lead principal investigator
1st name Shuichiro
Middle name
Last name Shiina
Organization Juntendo University Hospital
Division name Department of Gastroenterology
Zip code 113-8431
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email sshiina@juntendo.ac.jp

Public contact
Name of contact person
1st name Shuichiro
Middle name
Last name Shiina
Organization Juntendo University
Division name Department of Gastroenterology
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email sshiina@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hospital Ethics Committee Juntendo University Hospital
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel 03-3813-3111
Email kenkyu5858@juntendo.ac.jp

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

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 02 Month 15 Day
Date of IRB
2019 Year 02 Month 15 Day
Anticipated trial start date
2019 Year 02 Month 15 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 15 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041237

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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