Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema

BACKGROUND: Lymphedema is a pathologic soft tissue swelling that arises secondary to disruption of the lymphatic system. Lymphedema affects approximately 250 million people worldwide and causes significant physical and psychological morbidity. There is no definitive treatment for lymphedema. Lymphovenous bypass - microsurgically anastomosing lymphatic channels and venules - has demonstrated promising results in the treatment of lymphedema. PURPOSE: The purpose of this study is to determine the efficacy of lymphovenous bypass in treating extremity lymphedema. METHODS: This is a prospective, single-arm, cohort study. Eligible patients between 18-70 years of age with extremity lymphedema will undergo lymphovenous bypass. The primary outcome measure will be extremity volume and the secondary outcome measure will be quality of life assessed by a validated assessment tool for lymphedema of the limbs (LYMQOL). Patients will be assessed preoperatively and at 3, 6, 9, and 12-months postoperatively. Each participant will serve as their own control.

Primary and secondary outcome measures will be assessed with paired t-tests. With a sample size of 9 patients we will have at least 80% power to reject the null hypothesis assuming an alpha level of 0.01. To further increase the power and to account for patients lost to follow-up the investigators will target a patient recruitment of 20.

The findings of this study will help further elucidate the role of lymphovenous bypass in the treatment of extremity lymphedema.

Study Overview

• Status: Withdrawn
• Conditions: Lymph Leakage
• Intervention / Treatment: Procedure: Lymphovenous bypass

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18-70 years) with International Society of Lymphology Stage I-II lymphedema of the upper or lower extremity will be eligible for lymphovenous bypass.

Description

Inclusion Criteria:

1. 18-70 years.
2. Lymphedema of the upper or lower extremity.
3. International Society of Lymphology Stage I-II.

Exclusion Criteria:

1. Significant comorbidities that would preclude a patient from receiving a general anesthetic.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Lymphovenous bypass; Patients with extremity lymphedema treated with lymphovenous bypass.

Procedure: Lymphovenous bypass; Lymphovenous bypass will be performed under general anesthetic. Indocyanine green lymphangiography will be performed by injecting indocyanine green into each finger / toe web of the lymphedematous limb and mapping the lymphatic system with the NOVADAQ SPY Fluorescence Imaging (Mississauga, Canada). Subdermal dissection of lymphatics and venules will be carried out under a surgical microscope. Lymphatic vessels will be anastomosed to adjacent recipient venules to create the bypass between the lymphatic and the venous systems. In total, 1-5 anastomoses will be performed. This will require 1-5 incisions, each with a length of 2-3 cm. Postoperatively, the limb will be wrapped loosely with compression bandages. No special postoperative monitoring is required. The surgery will be performed on an outpatient basis with no planned hospital stay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extremity volume (v)	Extremity volume will be calculated using the truncated cone formula based on limb circumference measurements.	Assessed preoperatively and 12-months postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment tool for lymphedema of the limbs (LYMQOL).	Quality of life assessment tool for lymphedema of the limbs.	Assessed preoperatively and 12-months postoperatively.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of episodes of cellulitis (n / year)	Number of episodes of cellulitis requiring antimicrobial therapy (n / year).	Patient estimate from the 12-months preoperatively compared with 12-months postoperatively.
Need for ongoing compression therapy (yes / no)	Need for ongoing compression therapy as defined by the use of acute bandaging, compression garments, or manual compression therapy (yes / no).	Assessed preoperatively and 12-months postoperatively.

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Moein Momtazi, MD, Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Ottawa

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: September 16, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Lymphedema; Lymphovenous bypass
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 20180289-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No