LVA on Serum Profiling in Patients With Lymphedema

The Impact of Lymphaticovenous Anastomosis on Serum Profiling in Patients With Lymphedema

The correlation between oxidative stress and increased lymphedematous limb volume lacks supporting evidence. Lymphedema patients are prone to cellulitis. This study aims to investigate the link between oxidative stress, limb volume, and cellulitis after supermicrosurgical lymphaticovenous anastomosis (LVA).

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Other: pre-LVA; Other: post-LVA

Detailed Description

In this study, we focused on the changes in serum antioxidant biomarkers before and after LVA, detected by isobaric tags for relative and absolute quantitation (iTRAQ)-based quantitative proteomic analysis, enzyme-linked immunosorbent assay (ELISA), and Oxidative Stress Panel Kit. For clinical correlation, magnetic resonance (MR) volumetry was implemented for precise lymphedematous limb volume measurements. Correlations were made between changes in oxidative stress, limb volume, and cellulitis before and after LVA.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Written informed consent was obtained from all patients. Between June 2018 and May 2019, 26 patients with lower limb lymphedema confirmed with lymphoscintigraphy were recruited. Patients with upper limb and bilateral lower limb lymphedema were excluded.

Description

Inclusion Criteria:

• patients with lower limb lymphedema confirmed with lymphoscintigraphy
• unilateral lower limb lymphedema
• lymphedema duration > 2 years
• no active infection
• no prophylactic antibiotic use for at least one month before LVA
• no tumor recurrence or metastasis
• no consumption of antioxidants, such as vitamin E or ascorbic acid

Exclusion Criteria:

• Patients with upper limb and bilateral lower limb lymphedema

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients underwent supermicrosurgical LVA; Patients underwent supermicrosurgical LVA between June 2018 and May 2019.	Other: pre-LVA; Venous serum samples were collected from patients before LVA.; Other: post-LVA; Venous serum samples were collected from patients one-month after LVA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the correlation between post-LVA volume reduction	The primary outcome was determined whether post-LVA volume reduction < 40%	6 months after surgery

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): September 11, 2020

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 201800306B0

Drug and device information, study documents

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