Clinical Trial: A clinical study of direct lymphaticovenular anastomosis in the axillary region for patients undergoing axillary lymph node dissection for breast cancer (Japan)

Tokyo, April 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061217) titled 'A study of axillary lymphaticovenular anastomosis for the prevention of lymphedema in patients undergoing breast cancer surgery' on April 9.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Toyama University

Condition: Condition - Breast cancer and lymphedema Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 180

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070046

Disclaimer: Curated by HT Syndication.