Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA

Completed

• Conditions: Lymphedema
• Interventions: Procedure: lymphaticovenous anastomosis

• Registration Number: NCT06323200
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

This study aimed to address the impact of lymphedema duration on the quality of lymphatic vessels as well as the outcome after LVA using propensity score matching.

Detailed Description

With an increase in the incidence and treatment of breast and gynecological cancers, an increase in the prevalence of secondary lymphedema has been witnessed1. As a consequence of lymphadenectomy and adjuvant radiotherapy, swollen limbs result from the accumulation of protein rich fluid2. Lymphedema is predicted to arise in 20-40% of patients with cervical and breast cancer3, which is a chronic disease that can significantly hamper quality of life4-6. Affected limbs may suffer from lifelong swelling with functional impairment and repeated cellulitis, and some may eventually progress to late-stage diseases such as elephantiasis and lymphorrhea7-9.

Supermicrosurgical lymphaticovenous anastomosis (LVA) is a well-documented minimally invasive treatment modality that bypasses lymph into the venous system to alleviate lymphedema10-14. It was a common belief that a longer lymphedema duration (LD) may be associated with inferior lymphatic vessel (LVs) quality, as well as excess fibrous components in the affected limbs, which are characteristics of advanced lymphedema. Consequently, owing to inferior LV quality, LVA is considered unsuitable for advanced cases; instead, vascularized lymph node transfer (VLNT) or excisional procedures are recommended7,15.

However, growing evidence has demonstrated the effectiveness of LVA for the treatment of severe lymphedema16-19. These findings, contrary to common beliefs, raise questions regarding the association between LD, LV quality, and outcomes after LVA. This study aimed to address the impact of LD on the quality of LV as well as the outcome after LVA using propensity score matching.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2023-03
• Study Completion: 2023-03
• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from September 2015 to March 2023.

Patients who underwent LVA for unilateral lower-limb lymphedema.

Exclusion Criteria

• Primary lymphedema, bilateral lower limb lymphedema, history of previous LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure, and those that were lost to follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lymphedema duration > 3.6 years	lymphaticovenous anastomosis	-
Lymphedema duration ≤ 3.6 years	lymphaticovenous anastomosis	-

Primary Outcome Measures

Name	Time	Method
Volume change after LVA.	6/12 months	The primary endpoint was the volume change at 6/12 months after LVA.