Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema

NCT03683095 | Withdrawn

• 1 other identifier: 20180289-01H
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lymph Leakage

Keywords

Lymphedema; Lymphovenous bypass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life assessment tool for lymphedema of the limbs (LYMQOL).

  Assessed preoperatively and 12-months postoperatively.

Other Outcomes (2)

• Number of episodes of cellulitis (n / year)

  Patient estimate from the 12-months preoperatively compared with 12-months postoperatively.

• Need for ongoing compression therapy (yes / no)

  Assessed preoperatively and 12-months postoperatively.

Study Arms (1)

Lymphovenous bypass

Patients with extremity lymphedema treated with lymphovenous bypass.

Procedure: Lymphovenous bypass

Interventions

Lymphovenous bypass PROCEDURE

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.

Lymphovenous bypass

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years.
• Lymphedema of the upper or lower extremity.
• International Society of Lymphology Stage I-II.

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Moein Momtazi, MD

  Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: September 25, 2018
• Study Start: April 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share