LymphedemaLVANCT06323200
Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
An observational study of Lymphedema, run by Chang Gung Memorial Hospital.
Trial 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. 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
- Injection or infusion, Surgery or procedure
- How many people
- 189 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Mar 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All adult patients (age >20 years) receiving LVA for lower limb lymphedema at a tertiary medical center were retrospectively reviewed from September 2015 to March 2023.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: The Impact of Surgical Intervention on Lymphatic System in Patients With Lymphedema
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.
Read the 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.
- Conditions
- Lymphedema
- Being tested
- lymphaticovenous anastomosis
- Keywords
- retrospective cohort
- 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
The patients were under intravenous general anesthesia with local anesthetic infiltration for each incision21. LVs were detected by intradermal injection of ICG into the web spaces between the toes and on the medial and lateral malleoli. ICG flow with linear dermal backflow(DB) patterns was detected immediately using a handheld near-infrared camera. The recipient veins were marked using B-mode echo Doppler, close to the marked linear pattern. In case of DB pattern, the incision was made along the great saphenous vein. A 3 cm incision was made and the lymphatics and recipient veins were identified. All patients underwent supermicrosurgical LVA with 11- 0 nylon sutures using a high-power surgical microscope by a single senior surgeon. LVAs are performed using only antegrade flow lymphatics and lymphaticovenous end-to-end anastomosis (LVEEA) and end-to-side anastomosis (LVESA).
| Study group | Role | What they receive |
|---|---|---|
| Lymphedema duration > 3.6 years | Not described Receives: Procedure: lymphaticovenous anastomosis | |
| Lymphedema duration ≤ 3.6 years | Not described 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 posted21 Mar 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 189 participants (actual)
- Target duration
- 1 Year
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
- NCT06323200
- Sponsor's protocol ID
- 202400221B0
- Acronym
- LVA
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Surgical Intervention on Lymphatic System in Patients With Lymphedema
- ClinicalTrials.gov ID
- NCT06323200
- Acronym / sponsor ID
- LVA / 202400221B0
- Conditions
- Lymphedema
- Keywords
- retrospective cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 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
- 21 Mar 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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphedema duration > 3.6 years | – | Procedure: lymphaticovenous anastomosis |
| Lymphedema duration ≤ 3.6 years | – | Procedure: lymphaticovenous anastomosis |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients (age >20 years) receiving LVA for lower limb lymphedema at a tertiary medical center were retrospectively reviewed from September 2015 to March 2023.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 anastomosisThe patients were under intravenous general anesthesia with local anesthetic infiltration for each incision21. LVs were detected by intradermal injection of ICG into the web spaces between the toes and on the medial and lateral malleoli. ICG flow with linear dermal backflow(DB) patterns was detected immediately using a handheld near-infrared camera. The recipient veins were marked using B-mode echo Doppler, close to the marked linear pattern. In case of DB pattern, the incision was made along the great saphenous vein. A 3 cm incision was made and the lymphatics and recipient veins were identified. All patients underwent supermicrosurgical LVA with 11- 0 nylon sutures using a high-power surgical microscope by a single senior surgeon. LVAs are performed using only antegrade flow lymphatics and lymphaticovenous end-to-end anastomosis (LVEEA) and end-to-side anastomosis (LVESA). | Procedure or surgery | Lymphedema duration > 3.6 years, Lymphedema duration ≤ 3.6 years |
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 21 Mar 2024.
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, run by Chang Gung Memorial Hospital.
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 1 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 21 Mar 2024.