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

Early Phase 1

Terminated

• Conditions: Lymphedema; Post Mastectomy
• Interventions: Procedure: Lymphaticovenous Micro-Anastomosis

• Registration Number: NCT02020837
• Lead Sponsor: University of Arkansas

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Study Start: 2014-09
• Primary Completion: 2015-12-03
• Study Completion: 2017-07
• Results First Submitted: 2017-08-09
• Results First Submitted QC: 2017-09-13
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-06
• Results First Posted: 2018-04-09
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lymphaticovenous Micro-Anastomosis	Lymphaticovenous Micro-Anastomosis	-

Primary Outcome Measures

Name	Time	Method
Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery	3 and 6 months from surgery	Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States