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Clinical Trials in South Korea / NCT04687956
Recruiting Not applicable

Primary Surgical Prevention of Breast Cancer-related Lymphedema

NCT04687956 · tracked via the Priya Life Science South Korea tracker
Sponsor
Gangnam Severance Hospital
Phase
Not applicable
Started
2021-02-01
Last updated
2023-10-11

Condition(s) studied

LymphedemaMastectomyBreast Cancer

Investigational drug(s) / intervention(s)

LYMPHAcontrol

LYMPHA: Axillary reverse mapping is performed before surgery, axillary lymph node resection is performed, and 'LYMPHA' (Lymphatic microsurgical preventing healing approach) is performed, and the surgery is terminated. Subsequently, the occurrence of lymphedema is followed up.

control: In the control group, axillary lymph node resection is performed and the surgery is terminated without additional procedures. Subsequently, the occurrence of lymphedema is followed up.

Study summary

Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age over 19 years old 2. Patients who are expected to undergo surgery under the diagnosis of breast cancer, and are determined to undergo axillary lymph node dissection before surgery. Exclusion Criteria: 1. Patients with vascular and lymph-related diseases 2. Patients with a history of surgical treatment or trauma to both arms and axillary 3. Patients with a history of receiving radiation treatment in both arms, chest, and axilla 4. Patients with confirmed systemic metastasis with stage 4 breast cancer 5. Pregnant and lactating patients

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Gangnam Severance Hospital, Yonsei University College of Medicine Seoul South Korea Recruiting

More Gangnam Severance Hospital trials in South Korea

A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia Recruiting
Comparison of Full Robotic Instrumentation and Assistant-Controlled Laparoscopic Instrumentation in Robotic Distal Gastrectomy Recruiting
Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study) Recruiting
Comparison Partial Versus Total Omentectomy in Minimal Invasive Distal Gastrectomy for cT3/4a Gastric Cancer (KLASS-10) Recruiting
AI-based Rehabilitation for Hip and Knee Surgery Patients Starting soon

Other trials for the same condition

PALbociclib CoLlaborative Adjuvant Study Active, not recruiting
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer Recruiting
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer Active, not recruiting
A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia Recruiting
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04687956 on ClinicalTrials.gov ↗ ← All trials in South Korea