LVA on Serum Profiling in Patients With Lymphedema

September 16, 2020 updated by: Chang Gung Memorial Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 6 months after surgery
The primary outcome was determined whether post-LVA volume reduction < 40%
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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