UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052612 |
|---|---|
| Receipt number | R000059911 |
| Scientific Title | Multi-center retrospective study on efficacy and safety of new-generation microwave ablation in patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2023/10/26 |
| Last modified on | 2025/05/01 10:14:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multi-center retrospective study on efficacy and safety of new-generation microwave ablation in patients with hepatocellular carcinoma
Acronym
Multi-center retrospective study on efficacy and safety of new-generation MWA in patients with HCC
Scientific Title
Multi-center retrospective study on efficacy and safety of new-generation microwave ablation in patients with hepatocellular carcinoma
Scientific Title:Acronym
Multi-center retrospective study on efficacy and safety of new-generation MWA in patients with 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 evaluate the efficacy and safety of microwave ablation using the new-generation microwave treatment device, the Emprint Ablation System, in patients with hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint for the analysis on overall treatments is the incidence of complications classified according to the Clavien-Dindo classification.
The primary endpoint for the analysis on the patients who underwent microwave ablation as first-line treatment is the duration of local control.
Key secondary outcomes
The secondary endpoint for the analysis on overall treatments are the target lesion response based on the Modified RECIST from contrast-enhanced CT/MRI (short-term therapeutic effects). Additionally, the number of treatments required to achieve CR (complete response) and the duration of ablation will be analyzed. Furthermore, a stratified analysis will be conducted based on patient background factors for each outcome.
The secondary endpoint for the analysis on the patients who underwent microwave ablation as first-line treatment are the periods of overall survival and recurrence-free survival. Furthermore, a stratified analysis will be conducted based on patient background factors for each outcome.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hepatocellular carcinoma who underwent new-generation microwave ablation in participating institution will be included.
Key exclusion criteria
Patients under the age of 20.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Nobuhito |
| Middle name | |
| Last name | Taniki |
Organization
Keio University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
nobuhitotaniki@keio.jp
Public contact
Name of contact person
| 1st name | Nobuhito |
| Middle name | |
| Last name | Taniki |
Organization
Keio University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
nobuhitotaniki@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学医学部(東京都)
順天堂大学医学部(東京都)
東京大学医学部(東京都)
群馬県済生会前橋病院（群馬県）
山梨大学医学部(山梨県)
独立行政法人労働者健康安全機構和歌山労災病院(和歌山県)
岩手医科大学 医学部(岩手県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Outline of research methods
Retrospective study to investigate the effectiveness and safety of microwave ablation using the new-generation microwave therapy device, the Emprint Ablation System, in patients with hepatocellular carcinoma.
2.Study design
Multi-center, retrospective observational study.
3.Inclusion/exclusion criteria for study subjects
Inclusion criteria:
(1) Patients diagnosed with hepatocellular carcinoma either pathologically or radiologically.
(2) Patients who underwent microwave ablation using the new-generation microwave therapy device, the Emprint Ablation System, between April 1, 2017, and March 31, 2025.
Exclusion criteria:
(1) Patients under the age of 20.
Management information
Registered date
| 2023 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059911
