UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061632 |
|---|---|
| Receipt number | R000070517 |
| Scientific Title | Safety and Effectiveness of Adjunctive Fat Grafting in Postmastectomy Breast Reconstruction: A Multicenter Retrospective Observational Study in Japan |
| Date of disclosure of the study information | 2026/05/19 |
| Last modified on | 2026/05/19 14:43:48 |
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Basic information
Public title
Safety and Effectiveness of Fat Grafting as an Adjunct to Breast Reconstruction: A Multicenter Retrospective Observational Study in Japan
Acronym
JOPBS-HBR Retrospective Study
Scientific Title
Safety and Effectiveness of Adjunctive Fat Grafting in Postmastectomy Breast Reconstruction: A Multicenter Retrospective Observational Study in Japan
Scientific Title:Acronym
JOPBS-HBR Retrospective Study
Region
| Japan |
Condition
Condition
Postmastectomy breast defect
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to retrospectively collect multicenter data on clinical characteristics, postoperative complications, reoperations, aesthetic outcomes, and oncological outcomes in patients who underwent breast reconstruction with adjunctive fat grafting after breast cancer surgery, and to evaluate the safety and effectiveness of this approach.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the incidence of postoperative complications after breast reconstruction, including complications related to the reconstructed breast, fat-grafted site, and fat-harvest site.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who meet all of the following criteria will be included:
Patients who underwent postmastectomy breast reconstruction at a participating institution between January 1, 2013 and December 31, 2025.
Patients who underwent implant-based or autologous breast reconstruction.
Patients for whom medical record information is available regarding the use or non-use of adjunctive fat grafting and the major postoperative clinical course.
Female patients aged 18 years or older at the time of surgery.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
Patients with insufficient medical record information to determine the use or non-use of adjunctive fat grafting or to evaluate the primary outcome.
Patients whose procedures do not correspond to postmastectomy breast reconstruction, even if performed during the study period.
Patients who refuse the use of their clinical information for this study through the opt-out process.
Patients deemed unsuitable for inclusion in this study by the principal investigator or co-investigators.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Mashiko |
Organization
Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
Division name
Department of Plastic Surgery
Zip code
158-8531
Address
6-25-1, Kamiyoga, Setagaya-Ku, Tokyo, Japan
TEL
09072260121
aesthetic_qp@hotmail.com
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Mashiko |
Organization
Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
Division name
Department of Plastic Surgery
Zip code
158-8531
Address
6-25-1, Kamiyoga, Setagaya-Ku, Tokyo, Japan
TEL
09072260121
Homepage URL
aesthetic_qp@hotmail.com
Sponsor or person
Institute
Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
Institute
Department
Personal name
Funding Source
Organization
Japan Oncoplastic Breast Surgery Society
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
Research Ethics Committee of Kanto Central Hospital
Address
6-25-1, Kamiyoga, Setagaya-Ku, Tokyo, Japan
Tel
03-3429-1171
kanchu@kanto-ctr-hsp.com
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
| 2026 | Year | 05 | Month | 19 | 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
| 2026 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective observational study to evaluate the safety and effectiveness of adjunctive fat grafting in postmastectomy breast reconstruction. The study will include patients who underwent implant-based or autologous breast reconstruction at participating institutions between January 1, 2013 and December 31, 2025. Data on the use or non-use of adjunctive fat grafting, reconstruction method, patient characteristics, postoperative complications, reoperations, aesthetic outcomes, and oncological outcomes will be collected from medical records. The primary outcome is the incidence of postoperative complications. Comparisons will be made between patients with and without adjunctive fat grafting, with planned stratified analyses according to implant-based and autologous reconstruction.
Management information
Registered date
| 2026 | Year | 05 | Month | 19 | Day |
Last modified on
| 2026 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070517
