LymphedemaICG LVANCT06742242
The Use of Non-ICG-Enhanced Lymphatic Vessels for LVA
A study testing lymphaticovenous anastomosis in people with Lymphedema, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- lymphaticovenous anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2015to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Non-Indocyanine Green-Enhanced Lymphatic Vessels for Supermicrosurgical Lymphaticovenous Anastomosis: a Propensity-Score-Matched Outcome Analysis
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.
Read the detailed 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.
- Conditions
- Lymphedema
- Being tested
- lymphaticovenous anastomosis
- Keywords
- propensity score matching, LVA, Supermicrosurgery, lymphaticovenous anastomosis, lymphovenous bypass
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphaticovenous anastomosisProcedure or surgery
supermicrosurgical lymphatic vessel to recipient ven lumen-to-lumen coaptation
| Study group | Role | What they receive |
|---|---|---|
| The Use of Non-ICG-Enhanced Lymphatic Vessels for LVA | Experimental | The use of non-ICG-enhanced lymphatic vessels for LVA Receives: Procedure: lymphaticovenous anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume change after LVA.
The primary endpoint was the volume change at 6/12 months after LVA.
Measured: 6/12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study startSep 2015
- Primary completionMar 2023
- Study completionMar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742242
- Sponsor's protocol ID
- 202400198B0
- Acronym
- ICG LVA
- Status last verified
- Apr 2024
- First submitted
- 4 Oct 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Non-Indocyanine Green-Enhanced Lymphatic Vessels for Supermicrosurgical Lymphaticovenous Anastomosis: a Propensity-Score-Matched Outcome Analysis
- ClinicalTrials.gov ID
- NCT06742242
- Acronym / sponsor ID
- ICG LVA / 202400198B0
- Conditions
- Lymphedema
- Keywords
- propensity score matching, LVA, Supermicrosurgery, lymphaticovenous anastomosis, lymphovenous bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Use of Non-ICG-Enhanced Lymphatic Vessels for LVA | Experimental | Procedure: lymphaticovenous anastomosisThe use of non-ICG-enhanced lymphatic vessels for LVA |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lymphaticovenous anastomosissupermicrosurgical lymphatic vessel to recipient ven lumen-to-lumen coaptation | Procedure or surgery | The Use of Non-ICG-Enhanced Lymphatic Vessels for LVA |
Primary outcome
Volume change after LVA.
Time frame: 6/12 months
The primary endpoint was the volume change at 6/12 months after LVA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymphaticovenous anastomosis in people with Lymphedema, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume change after LVA. (time frame: 6/12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.