Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema

NCT05064176 | Recruiting DMC

• 1 other identifier: KCE19-1245
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this research proposal is to investigate

• in patients with lymphoedema of the upper limb or lower limb (P)
• the added value of reconstructive lymphatic surgery (I)
• to the decongestive lymphatic therapy (usual care) (C)
• on the lymphoedema-specific quality of life (QoL) (O)
• at 18 months post-surgery/ no surgery (T) Consequently, a multicentre pragmatic randomised controlled trial is performed to give an answer on following research question: 'Is, in addition to usual care - i.e. decongestive lymphatic therapy -, reconstructive lymphatic surgery (intervention group) superior to no surgery (control group), for the treatment of upper or lower limb lymphoedema?'

Conditions

Lymphoedema of Leg; Lymphedema Arm; Lymphedema

Keywords

Reconstructive lymphatic surgery; Decongestive lymphatic therapy; Lymphovenous anastomosis; Lymph node transfer

Outcome Measures

Primary Outcomes (1)

• Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)

  evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema

  at 18 months

Secondary Outcomes (16)

• Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)

  at 1, 3, 6, 12 (short term) and 24, 36 (longer term) months

• General health-related QoL

  at 1, 3, 6, 12, 18, 24, 36 months

• Limb volume

  at 1, 3, 6, 12, 18 (key secondary outcome), 24, 36 months

• Failure to reduce the hours a day of wearing the compression stocking

  at 12, 18, 24, 36 months

• The hours of wearing the compression garment during one week

  at 12, 18 (key secondary outcome), 24, 36 months

Study Arms (2)

Reconstructive lymphatic surgery

EXPERIMENTAL

The intervention treatment is reconstructive lymphatic surgery and consists of the application of lymphovenous anastomosis (LVA), lymph node transfer (LNT) or a combination of both. The choice of reconstructive technique(s) is determined by the surgeon and is based on the algorithm for reconstructive lymphatic surgery of lymphoedema. Additionally, all patients receive usual care (i.e. maintenance decongestive lymphatic therapy)

Other: Usual care; Procedure: Reconstructive lymphatic surgery

No surgery

ACTIVE COMPARATOR

All patients receive usual care (i.e. maintenance decongestive lymphatic therapy)

Other: Usual care

Interventions

Usual care OTHER

Home physical therapist performs usual care and educates the patient to perform self-management Usual care: M1-6: 6 months of maintenance decongestive lymphatic therapy (DLT) (by patient and home physical therapist): * week 1-2: no physical therapy; patient performs limb elevation, muscle contractions and wears the bandage (intervention group)/ compression garment (control group) * week 3-4: start physical therapy, 2 days/ week: exercises, skin care \& manual lymph drainage (MLD), education; self-management by patient and wearing compression garment 14-16h/day (4 sessions) M2-6: 1 day/ week physical therapist: exercises, skin care \& MLD, and self-management by patient and wearing compression garment 14-16h/day (20 sessions) M7-12: 6 months of maintenance DLT by patient (self-management) and home physical therapist: \- 1 day/week physical therapist: skin care, MLD, exercises (26 sessions) Month 13-18: 6 months of maintenance DLT by patient Month 19-36: 18 months of follow-up

No surgery; Reconstructive lymphatic surgery

Reconstructive lymphatic surgery PROCEDURE

For the procedure of LVA: \- Aim: making anastomoses of lymph vessels at the capillary level with a diameter of 0.3 to 0.8 mm, to redirect lymph to venous stream directly For the procedure of LNT: \- Aim: 1. Placed lymph nodes act as sponge to absorb lymphatic fluid and direct it into the vascular network; 2. Placed lymph nodes induce lymphangiogenesis

Reconstructive lymphatic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (3)

Ghent University Hospital

Ghent, Belgium

RECRUITING

University Hospitals of Leuven, center for lymphedema

Leuven, 3000, Belgium

RECRUITING

CHU-UCL Mont-Godinne

Namur, Belgium

RECRUITING

Related Publications (1)

• Devoogdt N, De Vrieze T, Heroes AK, Bechter-Hugl B, Fieuws S, Godderis L, Segers K, Maleux G, Deltombe T, Frippiat J, Servaes M, Berners A, Fosseprez P, Krug B, Kayser F, Falticeanu A, Randon C, Monten C, Van Landuyt K, De Pypere B, Degraeve L, Decorte T, De Schryver M, Van Besien V, Devos D, Suominen S, Ayala JM, Pons G, Fourneau I, Thomis S. SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema. BMJ Open. 2024 May 10;14(5):e078114. doi: 10.1136/bmjopen-2023-078114.

  PMID: 38729754 DERIVED

Related Links

• Belgium Health Care Knowledge Centre (KCE)
• Improving Care for Edema and Oncology patients (CarEdOn)

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Nele Devoogdt

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Thierry Deltombe

  CHU-UCL Mont-Godinne

  PRINCIPAL INVESTIGATOR

• Caren Randon

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nele Devoogdt

CONTACT

0032 16 34 25 15; nele.devoogdt@kuleuven.be

Tessa De Vrieze

CONTACT

0032 16 34 50 06; tessa.devrieze@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the nature of the trial, blinding of participants, the person who performs the trial assessments (= investigator) and care providers (surgeon/ physical therapist/ compression specialist) is not feasible. The person who will be performing data analyses (= outcome assessor) will be blinded to the participants' randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: October 1, 2021
• Study Start: February 1, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

BE (3)