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The Use of Non-ICG-Enhanced Lymphatic Vessels for LVA (ICG LVA)

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Lymphedema

Treatments

Procedure: lymphaticovenous anastomosis

Study type

Interventional

Funder types

Other

Identifiers

NCT06742242
202400198B0

Details and patient eligibility

About

The aim of the present study was to investigate the impact of non-ICG(+) LVs on the outcomes after LVA compared to ICG(+) LVs with propensity-score-match analysis.

Full description

It is a common belief among lymphatic supermicrosurgeons that LVA should only be performed with indocyanine green-enhanced (ICG(+)) LVs since such LVs are considered functional and are suitable for achieving better outcomes. However, in moderate to advance lymphedema patients, the use of non-ICG(+) LVs are inevitable despite efforts to identified ICG(+) LVs with ICG lymphography10, magnetic resonance (MR) lymphangiography11, or ultrasound12. In a previous study, it was suggested that a non-ICG(+) but flow-positive LV should also be considered functional because the functionality of an LV should be determined by its capability to transport lymph instead of ICG(+) lymph. Therefore, non- ICG(+) but flow-positive LVs should also be used for LVA to maximize the outcome13. This hypothesis was further supported by a recent article emphasizing the concept of a lymphatic-based lymphosome14, where it has been demonstrated that a functional LV will not become ICG(+) when ICG is not injected in the region being drained by this particular LV. It offers an explanation as to why a supposedly functional LV is not enhanced by ICG.

Enrollment

106 patients

Sex

All

Ages

20 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 treatment for lymphedema (LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure) - Those that were lost to follow-up.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

106 participants in 1 patient group

The Use of Non-ICG-Enhanced Lymphatic Vessels for LVA
Experimental group
Description:
The use of non-ICG-enhanced lymphatic vessels for LVA
Treatment:
Procedure: lymphaticovenous anastomosis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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