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

NCT ID: NCT06742242

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphedema

Keywords

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propensity score matching LVA Supermicrosurgery lymphaticovenous anastomosis lymphovenous bypass

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

The use of non-ICG-enhanced lymphatic vessels for LVA

Group Type EXPERIMENTAL

lymphaticovenous anastomosis

Intervention Type PROCEDURE

supermicrosurgical lymphatic vessel to recipient ven lumen-to-lumen coaptation

Interventions

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lymphaticovenous anastomosis

supermicrosurgical lymphatic vessel to recipient ven lumen-to-lumen coaptation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202400198B0

Identifier Type: -

Identifier Source: org_study_id