Reconstructive lymphatic surgery for treating lymphoedema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.