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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04328610
Other study ID # H-1912-010-086
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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