Effect of Lymphovenous Anastomosis on Lower Limb Lymphedema: Pragmatic Randomized Controlled Trial
NCT ID: NCT07073586
Last Updated: 2025-07-31
Study Results
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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RECRUITING
NA
66 participants
INTERVENTIONAL
2025-05-09
2029-08-31
Brief Summary
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Intervention arm - LVA surgery plus ongoing compression care
Control arm - Compression care only
Recruitment takes place at the Departments of Plastic Surgery, Herlev-Gentofte Hospital and Odense University Hospital. Outcomes are assessed by independent blinded staff at baseline, 6, 12 and 24 months. A biopsy substudy in ten LVA patients explores inflammatory and fibrotic changes. Primary endpoint is change in L-Dex ratio at 12 months. Secondary endpoints include limb volume, infection rate, lymphoscintigraphy findings, patient-reported outcomes, compression-garment use and anastomosis patency.
The trial follows Good Clinical Practice and General Data Protection Regulation (GDPR). Patients are covered by the Danish public patient-compensation scheme. Results will be published regardless of outcome, and control participants may opt for LVA after the 12-month visit.
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Detailed Description
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This multicentre pragmatic randomised trial will test whether lymphovenous anastomosis (LVA) can reduce lower-limb lymphedema and improve life quality in adults who have completed Complete Decongestive Therapy (CDT). The study is carried out at two Danish university hospitals that routinely manage complex lymphedema. A computer system assigns participants in a 1:1 ratio to either LVA plus compression care or compression care alone. Surgeons create as many anastomoses as possible under general anaesthesia, using indocyanine green mapping to find suitable lymphatic vessels.
Adults aged 18 years or older with International Society of Lymphology stage (ISL) 1 or 2a lymphedema of one or both legs can join if they have finished CDT. Key exclusions are stage 2b or 3 disease, body-mass index (BMI) above 28, active cancer, severe medical illness, or prior lymphedema surgery.
The primary outcome is the change in L-Dex ratio, from baseline to 12 months. Secondary outcomes measured at baseline, 6, 12 and 24 months include limb volume by tape, perometry and dual-energy X-ray absorptiometry, infection frequency, lymphoscintigraphy findings, quality-of-life scores (Lymphedema Quality of Life Questionnaire (LYMQOL) and EuroQol Five Dimension Five Level (EQ-5D-5L)) and use of compression garments. At 12 months the patency of the anastomoses is checked with indocyanine green lymphography in the surgical arm. A small substudy in ten surgical participants will compare inflammatory markers and tissue structure in paired skin biopsies collected during surgery and again 6 months later.
Participants attend the clinic for baseline, 6-month and 12-month visits and return at 24 months for long-term follow-up. Conservative measures such as compression garments may continue (but not reduced in 12 months for LVA-group), but no other surgical or medical lymphedema procedures are allowed during the study period.
All data are entered into a secure electronic database and analysed according to Good Clinical Practice, the Danish Code of Conduct for Research Integrity and General Data Protection Regulation (GDPR). The regional research ethics committee has approved the protocol, and participants are covered by the Danish public patient-compensation scheme. Results will be published in peer reviewed journals no matter whether LVA shows benefit, harm or no difference.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lymphovenous anastomosis (LVA) + Compression Therapy
LVA + conservative care. Patient must have undergone Complete Decongestive Therapy (CDT) and comply with the compression treatment. Follow-up at 6, 12 and 24 months includes blinded assessment of L-Dex, tape and perometry volumes, DXA, lymphoscintigraphy, erysipelas incidence and LYMQOL/EQ-5D-5L scores; patency is checked by ICG-lymphography at 12 months. A subset of 10 patients with unilateral lymphedema also provides paired skin biopsies (both legs) at surgery and again 6 months postoperatively for biomarker and histological analysis.
Lymphovenous Anastomosis
Microsurgical creation of multiple lymphatic-venous connections in the most affected limb under general anaesthesia.
Complete Decongestive Therapy
Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments.
Compression Therapy Alone
Conservative care alone. Participants complete standard Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments. Outcomes are assessed by the same blinded schedule as the LVA arm at baseline, 6, 12 and 24 months. Participants may elect LVA crossover after the 12-month evaluation if desired.
Complete Decongestive Therapy
Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments.
Interventions
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Lymphovenous Anastomosis
Microsurgical creation of multiple lymphatic-venous connections in the most affected limb under general anaesthesia.
Complete Decongestive Therapy
Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cancer-free with no recurrence for at least one year
* Age 18 or above
* Circumference of the affected leg is at least 1 cm larger than the non-lymphedema leg at the most affected site of lymphedema.
* Proficiency in Danish language, and ability to provide informed consent.
* Dermal Backflow Stage 0-4
Exclusion Criteria
* Medical conditions contraindicating surgical intervention or anesthesia, such as severe heart or lung disease
* Allergy to ICG
* Ongoing infections or skin diseases in the affected limb
* Previous surgery or other treatment modalities that could interfere with the study results (previous LVA, liposuction or similar).
* Dermal Backflow Stage 5
* Active cancer
* Heart or kidney conditions that can cause leg swelling
* A BMI above 28 kg/m²
* Current smoker
* Any foreign objects in the lower extremities (e.g., metal implants, prostheses)
* Venous insufficiency Unilateral weakness in the lower extremity (e.g., after a stroke)
* Known iodine allergy (contraindication for ICG injection)
* Leg length discrepancy (anisomelia) \> 1.5 cm
18 Years
ALL
No
Sponsors
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Herlev and Gentofte Hospital
OTHER
Responsible Party
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Amar Bucan
Medical doctor
Principal Investigators
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Lisbet Rosenkrantz Hölmich, MD, Professor, DMSc
Role: STUDY_CHAIR
Department of Plastic Surgery, Herlev and Gentofte Hospital, Denmark
Locations
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Department of Plastic Surgery, Odense University Hospital
Odense, Fyn, Denmark
Department of Plastic Surgery, Herlev and Gentofte Hospital
Herlev, Region Sjælland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-25012096
Identifier Type: -
Identifier Source: org_study_id
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