UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061217 |
|---|---|
| Receipt number | R000070046 |
| Scientific Title | A clinical study of direct lymphaticovenular anastomosis in the axillary region for patients undergoing axillary lymph node dissection for breast cancer |
| Date of disclosure of the study information | 2026/04/09 |
| Last modified on | 2026/04/09 19:46:32 |
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Basic information
Public title
A study of axillary lymphaticovenular anastomosis for the prevention of lymphedema in patients undergoing breast cancer surgery
Acronym
LVA study for the prevention of lymphedema after breast cancer surgery
Scientific Title
A clinical study of direct lymphaticovenular anastomosis in the axillary region for patients undergoing axillary lymph node dissection for breast cancer
Scientific Title:Acronym
Axillary Direct LVA Study
Region
| Japan |
Condition
Condition
Breast cancer and lymphedema
Classification by specialty
| Breast surgery | Plastic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of Direct lymphaticovenular anastomosis in the axillary region for preventing upper extremity lymphedema in patients undergoing axillary lymph node dissection for breast cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of upper extremity lymphedema within 2 years after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
During axillary lymph node dissection for breast cancer, lymphaticovenular anastomosis (LVA) is additionally performed in the axillary region by anastomosing upper extremity lymphatic vessels identified using indocyanine green (ICG) fluorescence imaging to nearby veins.
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
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
Female patients aged 18 years or older
Patients with primary breast cancer scheduled to undergo axillary lymph node dissection based on clinical guidelines or institutional tumor board decisions
Patients who have provided written informed consent for participation in this study
Key exclusion criteria
Patients with inflammatory breast cancer
Patients with poor long-term prognosis
Patients in whom no lymphatic vessel injury is identified intraoperatively
Patients deemed inappropriate for participation by the investigator
Patients who do not provide informed consen
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Onoda |
Organization
Toyama University Hospital
Division name
Department of Plastic and Reconstructive Surgery and Aesthetic Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
TEL
0764342281
satoshi@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kahori |
| Middle name | |
| Last name | Tsukura |
Organization
Toyama University Hospital
Division name
Department of Plastic and Reconstructive Surgery and Aesthetic Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
TEL
0764342281
Homepage URL
ktsukura73tyrd@gmail.com
Sponsor or person
Institute
Toyama University
Institute
Department
Personal name
Funding Source
Organization
Astellas Foundation for Research on Metabolic Disorders
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Life Science and Medical Research Involving Human Subjects, University of Toyama
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
Tel
0764342281
rinri@adm.u-toyama.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
| 2026 | Year | 04 | Month | 09 | 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 | 27 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | 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
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070046
