Reconstructive lymphatic surgery for treating lymphoedema
Comparison of Reconstructive Lymphatic Surgery Versus no Surgery, Additional to Decongestive Lymphatic Therapy (Usual Care), for the Treatment of Iymphoedema, Through a Multicentre Randomised Controlled Trial
This study tests if adding reconstructive lymphatic surgery to regular treatment can help people with lymphoedema in their arms or legs feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Ghent and 2 other locations) |
| Trial ID | NCT05064176 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of reconstructive lymphatic surgery in addition to standard decongestive lymphatic therapy for patients suffering from lymphoedema in the upper or lower limbs. The study is designed as a multicentre pragmatic randomized controlled trial, comparing outcomes between patients receiving the surgical intervention and those receiving usual care alone. The primary focus is on assessing the impact of these treatments on lymphoedema-specific quality of life at 18 months post-intervention. By potentially improving lymphatic transport, the surgery aims to reduce limb swelling and enhance overall patient functioning and well-being.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unilateral or bilateral primary or secondary lymphoedema of the upper or lower limbs who have undergone at least six months of decongestive lymphatic therapy.
Not a fit: Patients with a history of liposuction or those with advanced stages of lymphoedema may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with lymphoedema by reducing symptoms and enhancing limb function.
How similar studies have performed: Previous studies have shown promising results with reconstructive lymphatic surgery, indicating potential benefits, although this specific approach is being rigorously tested in a controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral or bilateral, primary or secondary lymphoedema of the upper or lower limb * If cancer-related lymphoedema, approval for participation in study from oncological specialist (patient participation has to be discussed during Multidisciplinary Oncological Consult); approval if: * estimated cancer-related survival is ≥3 years * oncological safety is guaranteed: for instance, time interval since radiotherapy/ chemotherapy is ≥3 months * Lymphoedema stage 1 to 2b * Objective diagnosis of lymphoedema: ≥ 5% volume difference OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of IndoCyanineGreen (ICG) dermal backflow * Score on Lymph-ICF questionnaire at screening: ≥ 25 / 100 (= moderate level of problems in functioning related to the development of lymphoedema) * History of at least 6 months of decongestive lymphatic therapy (DLT) until minimal pitting * Age ≥ 18 years Exclusion Criteria: * Participants with history of liposuction, lymphovenous anastomosis, lymph node transfer * Pregnant participants * Severe obese participants: BMI\>35 * Estimated cancer-related survival is \<3 years and oncological safety is not guaranteed (e.g. interval since radiotherapy/ chemotherapy is \<3 months) * In case of lower limb lymphoedema: presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome * Allergy for ICG, iodine, penicillin and sulphonamides; increased activity of thyroid gland; benign tumour in thyroid; heparin use and severe renal insufficiency
Where this trial is running
Ghent and 2 other locations
- Ghent University Hospital — Ghent, Belgium (Recruiting)
- University Hospitals of Leuven, center for lymphedema — Leuven, Belgium (Recruiting)
- CHU-UCL Mont-Godinne — Namur, Belgium (Recruiting)
Study contacts
- Principal investigator: Nele Devoogdt — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Nele Devoogdt
- Email: nele.devoogdt@kuleuven.be
- Phone: 0032 16 34 25 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.