To Assess the Efficacy of the LYMPHA in the Prevention of Lymphedema Following Axillary Dissection for Breast Cancer
LYMPHA
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
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2020
CompletedFirst Submitted
Initial submission to the registry
March 29, 2020
CompletedFirst Posted
Study publicly available on registry
March 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedMarch 16, 2021
March 1, 2021
2 years
March 29, 2020
March 13, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
lymphatic flow
Difference in lymphatic flow between LYMPHA technique group and Non-LYMPHA technique group
6 months
limb volume
Difference in limb volume between LYMPHA technique group and Non-LYMPHA technique group
6 months
lymphatic flow
Difference in lymphatic flow between LYMPHA technique group and Non-LYMPHA technique group
1 year
limb volume
Difference in limb volume between LYMPHA technique group and Non-LYMPHA technique group
1 year
Study Arms (2)
LYMPHA technique group
EXPERIMENTALLVA at the time of Axillary Dissection
Non-LYMPHA technique group
NO INTERVENTIONNo preventive surgical approach
Interventions
Patients will receive a lymphatic-venous anastomosis at time of their required Axillary Dissection
Eligibility Criteria
You may qualify if:
- Node-positive cancer requiring an axillary or lymphadenectomy
- Below 30 Body Mass Index
You may not qualify if:
- Patients receiving a sentinel lymph node biopsy
- Patients with established preoperative lymphedema
- Patients with post-thrombotic syndrome, peripheral vascular disease
- Pregnant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Hospital
Busan, Seo-Gu, 49241, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2020
First Posted
March 31, 2020
Study Start
March 5, 2020
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
March 16, 2021
Record last verified: 2021-03