Clinical trial NCT05064176: Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphoedema of Leg
Lymphedema Arm
Lymphedema
Keywords: Reconstructive lymphatic surgery
Decongestive lymphatic therapy
Lymphovenous anastomosis
Lymph node transfer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?'

Detailed description: Lymphoedema is a chronic and often debilitating condition caused by lymphatic insufficiency. It leads to swelling of the limb and an increased risk of infection. It can be classified as primary (congenital) or secondary (acquired) lymphoedema.

Lymphoedema is very burdensome for the patient and therefore is it often associated with mental problems for example frustration and stress. In addition, because of the increase in volume of the limb, patients also develop physical problems, such as pain, heaviness, loss of strength, and develop functional problems, such as problems with household, mobility or social activities. These mental, physical and functional problems all have a negative impact on quality of life and have an influence on the ability to work. Consensus exist that the first choice of treatment is a conservative treatment. This conservative treatment consists of skin care, compression therapy (i.e. multilayer bandaging and compression garments), exercises and lymph drainage. Reconstructive lymphatic surgery is another option, also often performed: i.e. lymphovenous anastomoses, on the one hand, and a lymph node transfer, on the other hand. By (partially) restoring the lymphatic transport, the reconstructive lymphatic surgery may possibly lead to a larger decrease of the lymphoedema volume and therefore greater discontinuation of the compression garment. Consequently, patients will have an improvement in functioning and quality of life.

Currently, scientific evidence for reconstructive lymphatic surgery for the treatment of lymphoedema is missing. Therefore, the aim of this trial is to investigate the added value of reconstructive lymphatic surgery of the lymphatic system in addition to the conservative treatment, for the treatment of lymphoedema.

Eligibility 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

Primary outcomes:
measure: Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)
timeFrame: at 18 months
Secondary outcomes:
measure: Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)
timeFrame: at 1, 3, 6, 12 (short term) and 24, 36 (longer term) months
measure: General health-related QoL
timeFrame: at 1, 3, 6, 12, 18, 24, 36 months
measure: Limb volume
timeFrame: at 1, 3, 6, 12, 18 (key secondary outcome), 24, 36 months
measure: Failure to reduce the hours a day of wearing the compression stocking
timeFrame: at 12, 18, 24, 36 months
measure: The hours of wearing the compression garment during one week
timeFrame: at 12, 18 (key secondary outcome), 24, 36 months
measure: The experience of the compression garment
timeFrame: at 1, 3, 6, 12, 18, 24, 36 months
measure: The physical activity level
timeFrame: at 1, 3, 6, 12, 18, 24, 36 months
measure: The need for intensive treatment due to an increase in lymphoedema volume
timeFrame: at 6, 12, 18, 24, 36 months
measure: Body weight
timeFrame: at 1, 3, 6, 12, 18, 24, 36 months
measure: Work capacity
timeFrame: at 1, 3, 6, 12, 18, 24, 36 months
measure: Work ability
timeFrame: at 1, 3, 6, 12, 18, 24, 36 months
measure: Infection during the previous 18 months (yes/no)
timeFrame: at 18, 36 months (adverse events are collected during each clinical assessment but the amount of infections as secondary outcome are taken together for statistical analyses per 18 months)
measure: Complications of surgery
timeFrame: at 1, 3, 6, 12, 18, 24, 36 months
measure: Recurrence of cancer (yes/no)
timeFrame: at 36 months
measure: Lymphatic transport
timeFrame: at 18 months
measure: Costs related to lymphoedema and its treatment during previous 18 months
timeFrame: at 18, 36 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Leuven
country: Belgium
facility: University Hospitals of Leuven, center for lymphedema
city: Namur
country: Belgium
facility: CHU-UCL Mont-Godinne
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Nele Devoogdt
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU-UCL Mont-Godinne
name: Thierry Deltombe
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Caren Randon
role: PRINCIPAL_INVESTIGATOR
References: