LVA on Serum Profiling in Patients With Lymphedema

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552938
• Other study ID #: 201800306B0
• Status: Completed
• Start date: April 11, 2018
• Est. completion date: September 11, 2020

Study information

• Verified date: April 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 11, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema

Intervention

Other:
• pre-LVA
Venous serum samples were collected from patients before LVA.
• post-LVA
Venous serum samples were collected from patients one-month after LVA.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the correlation between post-LVA volume reduction	The primary outcome was determined whether post-LVA volume reduction < 40%	6 months after surgery