UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062117 |
|---|---|
| Receipt number | R000070971 |
| Scientific Title | A Prospective Observational Study to Evaluate the Safety of Implant-Based Breast Reconstruction with Prepectoral Placement in Breast Surgery |
| Date of disclosure of the study information | 2026/07/02 |
| Last modified on | 2026/07/02 11:34:59 |
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Basic information
Public title
A Prospective Observational Study to Evaluate the Safety of Implant-Based Breast Reconstruction with Prepectoral Placement in Breast Surgery
Acronym
Ganken Prepectoral Reconstruction Study
Scientific Title
A Prospective Observational Study to Evaluate the Safety of Implant-Based Breast Reconstruction with Prepectoral Placement in Breast Surgery
Scientific Title:Acronym
Ganken Prepectoral Reconstruction Study
Region
| Japan |
Condition
Condition
Breast Cancer: Hereditary Breast and Ovarian Cancer Syndrome
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the safety of placing tissue expanders or gel-filled breast implants in front of the pectoralis major muscle in patients undergoing nipple-sparing mastectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of major complications, infection, reoperation, and implant removal or loss) within 90 days following prepectoral expander or implant placement
Key secondary outcomes
Surgical Outcomes: Operating time, time required for reconstruction, intraoperative blood loss, length of hospital stay, and number of days until drain removal
Aesthetic Evaluation: Postoperative breast aesthetics are evaluated using the Harvard Scale (assessed by the attending physician and two other physicians) for subjective evaluation, and BCCT.core for objective evaluation.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 18 to 75 years at the time of study enrollment;
2) Patients receiving outpatient treatment at this hospital;
3) Patients with clinical stage cTis, 1-2, N0 breast cancer or patients with hereditary breast and ovarian cancer syndrome (HBOC) who are scheduled for risk-reducing mastectomy (RRM)
4) Patients who wish to undergo minimally invasive breast surgery (endoscopic or robot-assisted nipple-sparing mastectomy) followed by postoperative breast reconstruction using implants
5) Patients with no extension or invasion into the nipple-areola complex (NAC) or the skin;
6) Patients who have obtained a skin flap thickness of 1 cm or more, or patients who have secured a breast skin flap thickness of 5 mm or more and are deemed to have no issues with skin blood flow as assessed by methods such as ICG fluorescence angiography;
7) patients who can tolerate general anesthesia
Key exclusion criteria
1) Smokers (at the time consent is obtained)
2) Obese individuals (BMI of 30 or higher at the time consent is obtained)
3) Any other individuals deemed unsuitable by the physician
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ueno |
Organization
Cancer Institute Hospital of JFCR
Division name
Breast Surgical Oncology, Breast Center
Zip code
1358550
Address
Ariake 3-8-31, Koto-ku, Tokyo, Japan
TEL
0335200111
takehiko.sakai@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Sakai |
Organization
Cancer Institute Hospital of JFCR
Division name
Breast Surgical Oncology, Breast Center
Zip code
1358550
Address
3-8-31, Ariake, Koto,
TEL
0335200111
Homepage URL
takehiko.sakai@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital of JFCR
Institute
Department
Personal name
Takehiko Sakai
Funding Source
Organization
Cancer Institute Hospital of JFCR
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review and Management Office
Address
Ariake3-8-31, Koto-ku
Tel
0335200111
med.shinsa@jfcr.or.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
| 2026 | Year | 07 | Month | 02 | 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
| 2026 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For eligible cases in which patient consent has been obtained, the following clinical and pathological information will be extracted:
1. Clinical findings (age, height, weight, medical history, family history, smoking history)
2. Clinicopathological findings (clinical stage, preoperative and postoperative information on breast cancer)
3. Surgical details (mastectomy, axillary lymph node dissection, breast reconstruction)
4. Hospital course and presence or absence of perioperative complications
5. Treatment (details of perioperative treatment)
Management information
Registered date
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070971
