Primary Surgical Prevention of Breast Cancer-related Lymphedema

Not Applicable

Recruiting

• Conditions: Breast Cancer; Mastectomy; Lymphedema
• Interventions: Procedure: LYMPHA; Procedure: control

• Registration Number: NCT04687956
• Lead Sponsor: Gangnam Severance Hospital

Brief 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.

Detailed Description

Patients in the LYMPHA group undergo Axillary reverse mapping before the start of surgery, and after axillary lymph node resection, LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.

Study Timeline

• Study First Submitted: 2020-11-29
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-29
• Study Start: 2021-02-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LYMPHA	LYMPHA	LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.
Control	control	No LYMPHA procedure is performed

Primary Outcome Measures

Name	Time	Method
Incidence of lymphedema	2 years after surgery	To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.

Secondary Outcome Measures

Name	Time	Method
5-year overall survival rate	5 years after surgery	To compare the overall survival rate
UEL index	2 years after surgery	To compare the UEL index
Changes in Lymphoscintigraphy	2 years after surgery	To compare the changes in lymphoscintigraphy presented by the change of transport index (TI)
Incidence of lymphedema	5 years after surgery	To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery.
5-year recurrence rate	5 years after surgery	To compare the recurrence rate

Trial Locations

Locations (1)

Gangnam Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of