A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema



Status:Terminated
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 70
Updated:6/29/2018
Start Date:September 2014
End Date:July 2017

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Trial Summary
Trial Overview
Inclusion Criteria
This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of
postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous
micro-anastomosis in the distal arm will result in the reduction of volume and improvement in
quality of life of patients with post-mastectomy lymphedema


Inclusion Criteria:

- Subject is 18-70 years of age

- Subject is Stage II-IV unilateral lymphedema

Exclusion Criteria:

- Subject is less than 6 months from completion of cancer treatment

- Subject has allergic reaction to the lymphatic contrast agent (Indocyanine Blue)

- Subject is medically unfit for the procedure

- Subject is unable to complete the follow-up visits

- Women with a positive urine pregnancy test are excluded from this study; women of
childbearing potential (defined as those who have not undergone a hysterectomy or who
have not been postmenopausal for at least 24 consecutive months) must agree to refrain
from breast feeding and practice adequate contraception as specified in the informed
consent. Adequate contraception consists of oral contraceptive, implantable
contraceptives, injectable contraceptives, a double barrier method, or abstinence.

- Subject has bilateral lymphedema
We found this trial at
1
site
University of Arkansas for Medical Sciences
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Mauricio Moreno, MD
Phone: 501-686-8274
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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from
Little Rock, AR
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