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

NCT ID: NCT04328610

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-05
• Study Completion Date: 2022-02-28

Brief 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.

Detailed 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.

Conditions

Lymphedema, Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LYMPHA technique group

LVA at the time of Axillary Dissection

Group Type: EXPERIMENTAL

LYMPHA(LYmphatic Microsurgical Preventive Healing Approach) technique

Intervention Type: PROCEDURE

Patients will receive a lymphatic-venous anastomosis at time of their required Axillary Dissection

Non-LYMPHA technique group

No preventive surgical approach

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LYMPHA(LYmphatic Microsurgical Preventive Healing Approach) technique

Patients will receive a lymphatic-venous anastomosis at time of their required Axillary Dissection

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pusan National University Hospital

Busan, Seo-Gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jin A Yoon, MD, Ph.D

Role: CONTACT

yjk5289@naver.com

+82-51-240-7845

Facility Contacts

Jin A Yoon, MD, Ph.D

Role: primary

yjk5289@naver.com

+82-51-240-7485

Other Identifiers

H-1912-010-086

Identifier Type: -

Identifier Source: org_study_id