To Assess the Efficacy of the LYMPHA in the Prevention of Lymphedema Following Axillary Dissection for Breast Cancer

Lymphedema, Breast Cancer Clinical Trial

— LYMPHA  

Official title:

A Randomized Controlled Trial to Assess the Efficacy of the Lymphatic Microsurgical Preventive Healing Approach (LYMPHA) to Prevent Lymphedema After Axillary Dissection for Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04328610
• Other study ID #: H-1912-010-086
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2021
• Source: Pusan National University Hospital
• Contact: Jin A Yoon, MD, Ph.D
• Phone: +82-51-240-7845
• Email: yjk5289[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lymphedema is the Build-up of Lymph Fluid in the Body's Tissue Causing Chronic, Debilitating Swelling. This Commonly Occurs as a Result of a Disruption of the Lymphatic System During Lymph Node Dissection Surgeries. LYMPHA (LYmphatic Microsurgical Preventive Healing Approach) is an Innovative Microsurgical Technique Where Blocked Lymphatic Vessels Are Drained Into the Blood Circulation by Surgically Creating a Shunt Between a Lymphatic Channel and a Blood Vessel Called a Lymphatic-venous Bypass. Recently, LYMPHA Technique Has Been Shown to Prevent Lymphedema When Performed at the Time of Nodal Dissection. We Propose a Prospective Study Evaluating the Effectiveness of LYMPHA Technique Using Objective Clinical Protocol.

Description:

Consenting patients will have the LYMPHA procedure at the time of planned axillary dissection surgery for the prevention of upper and extremity lymphedema. The node dissection will be performed by Dr. Kang while the LYMPHA technique will be performed by the plastic surgeon, Dr. Kim. The LYMPHA procedure consist of performing LVA at the time of the node dissection. Patent blue dye will be injected in the volar surface of the upper third of the arm in a quantity of about 1-2 ml intradermally, subcutaneously, and under muscular fascia into patient approximately 10 minutes before skin incision. This will allow mapping of the lymphatic channels for identification for bypass. The node dissection will then be performed with preservation of the anterior branch of the axillary vein in the axilla. Afferent lymphatic vessels will be sutured into a branch of the axillary vein distal to a competen valve. The total duration of the surgery is approximately 3 hours. The LYMPHA technique accounts for an additional 30 min to the standard 2-2.5 hours allocated to the node dissection. Pre-surgery, patients will have baseline limb circumference measurements of both the surgery-affected and unaffected arms and by lymphoscintigraphy. Patients will be followed up clinically at every 6 months up to a year. At each follow-up visit, patients will have a physical examination and their circumference of their limbs taken. Patients will also fill out a LyQLI, SF-36, DASH administered by the Clinical Research Coordinator pre-and post-surgery. Each patient will have a total of 1 years of participation time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Node-positive cancer requiring an axillary or lymphadenectomy
• Below 30 Body Mass Index

Exclusion Criteria:

• Patients receiving a sentinel lymph node biopsy
• Patients with established preoperative lymphedema
• Patients with post-thrombotic syndrome, peripheral vascular disease
• Pregnant patients

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema, Breast Cancer

Intervention

Procedure:
• LYMPHA(LYmphatic Microsurgical Preventive Healing Approach) technique
Patients will receive a lymphatic-venous anastomosis at time of their required Axillary Dissection

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan	Seo-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lymphatic flow	Difference in lymphatic flow between LYMPHA technique group and Non-LYMPHA technique group	6 months
Primary	limb volume	Difference in limb volume between LYMPHA technique group and Non-LYMPHA technique group	6 months
Primary	lymphatic flow	Difference in lymphatic flow between LYMPHA technique group and Non-LYMPHA technique group	1 year
Primary	limb volume	Difference in limb volume between LYMPHA technique group and Non-LYMPHA technique group	1 year