UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036206 |
|---|---|
| Receipt number | 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 | 2024/03/18 10:24:36 |
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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
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
sshiina@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Completed
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
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041237
