Trial Title:
The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema
NCT ID:
NCT06082349
Condition:
Lymphedema, Secondary
Lymphedema of Upper Limb
Lymphedema, Lower Limb
Lymphedema Arm
Lymphedema of Leg
Conditions: Official terms:
Lymphedema
Conditions: Keywords:
Lymphaticovenous anastomosis
Sham surgery
Microsurgery
LVA
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Multicenter, double-blind, randomized sham-controlled trial
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
The researcher, research nurse and patients will be blinded. The blinded researcher and
research nurse will perform the measurements during follow-up, as well as the assessment
of the outcomes. Due to the nature of the study, the surgeon performing both procedures
cannot be blinded.
Intervention:
Intervention type:
Procedure
Intervention name:
Lymphaticovenous anastomosis
Description:
Lymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to a adjacent
vein of similar size, thereby facilitating the ouflow of lymphatic fluid in patients
suffering from secondary lymphedema
Arm group label:
Lymphaticovenous anastomosis (LVA)
Other name:
LVA
Other name:
Lymphaticovenular anastomosis
Other name:
Lymphovenous bypass
Other name:
Lymphatic-venous shunt
Intervention type:
Procedure
Intervention name:
Sham surgery
Description:
Sham surgery involves the process of surgery, including local anesthesia and incisions,
but no LVA is made.
Arm group label:
Sham surgery
Other name:
Placebo surgery
Other name:
Simulated surgery
Other name:
Surgical placebo
Summary:
The goal of this randomized controlled trial is to compare the effectiveness and
cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients
suffering from unilateral cancer-related lymphedema in either the upper or lower
extremity. It aims to answer whether LVA is more effective than sham surgery in terms of
improvement in Lymph-ICF score.
A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio.
The first group will receive lymphaticovenous anastomosis (LVA), while the second group
will undergo sham surgery.
Detailed description:
One of the most debilitating side effects of cancer treatment is cancer-related
lymphedema (CRL), with an overall incidence of 15.5%. To date, there is no definite cure
for lymphedema. Conservative therapy, namely complex decongestive therapy is the golden
standard for the treatment. Lymphaticovenous anastomosis (LVA) might be a promising
treatment modality for patients with CRL, but available studies are small and the quality
is lacking. No large-scale prospective or randomized studies have been published on the
efficacy of LVA.
The main objective of this randomized controlled trial is to assess whether LVA is more
effective than sham surgery in terms of improvement in Lymph-ICF score, volume reduction,
reduction of complex decongestive therapy, and cost-effectiveness.
The study will take place in three centers in the Netherlands: Maastricht University
Medical Center, Radboud University Medical Center, and Erasmus University Medical Center.
The patients will be randomly distributed into two groups: the LVA group or the Sham
group. Both procedures are performed under local anesthesia. Patients in both groups are
subject to minor surgical complications (wound infection, bleeding, wound dehiscence).
Special care will be taken to prevent damage to lymphatic vessels in the Sham group, to
allow a future LVA operation once the study ends. The follow-up moments will be at 3, 6,
12, 18, and 24 months. Additionally, a subset of patients will partake in an annual
extended follow-up, ongoing until the start of the analysis. Each follow-up moment will
last 45 minutes in total. The patient also receives two digital questionnaires at each
follow-up moment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Treated for cancer and underwent treatment of either axillary or inguinal lymph
nodes or radiotherapy;
- Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by
lymphoscintigraphy for the lower extremity;
- Unilateral lymphedema;
- Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage
II-III);
- Refractory lymphedema that underwent at least three months of conservative
treatment;
- Informed consent.
Exclusion Criteria:
- History of lymphatic reconstruction in the past 10 years;
- Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) with
evident fat deposition and/or fibrosis;
- Patients with active distant metastases, treated with palliative intent;
- Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy,
and/or chemotherapy. Note: patients receiving adjuvant targeted and/or endocrine
treatment are eligible;
- Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deep
and superficial venous system;
- Active infection in the lymphedematous extremity;
- Bilateral lymphedema;
- Lymphedema present in genital or breast area only;
- Primary lymphedema;
- Non-viable lymphatic system as determined by ICG Lymphography (stages IV and V).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Radboud University Medical Center
Address:
City:
Nijmegen
Zip:
6525GA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Alieske Kleeven, MSc
Phone:
+31(0)433877481
Email:
alieske.kleeven@mumc.nl
Investigator:
Last name:
Stefan Hummelink, MSc, PhD
Email:
Principal Investigator
Investigator:
Last name:
Alieske Kleeven, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Yasmine Jonis, MSc
Email:
Sub-Investigator
Facility:
Name:
Maastricht University Medical Center
Address:
City:
Maastricht
Zip:
6229HX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Alieske Kleeven, MSc
Phone:
+31(0)433877481
Email:
alieske.kleeven@mumc.nl
Investigator:
Last name:
Shan Shan Qiu Shao, MSc, PhD
Email:
Principal Investigator
Investigator:
Last name:
Alieske Kleeven, MSc
Email:
Sub-Investigator
Facility:
Name:
Erasmus University Medical Center
Address:
City:
Rotterdam
Zip:
3015GD
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Alieske Kleeven, MSc
Phone:
+31(0)433877481
Email:
alieske.kleeven@mumc.nl
Investigator:
Last name:
Dalibor Vasilic, MSc, PhD
Email:
Principal Investigator
Investigator:
Last name:
Alieske Kleeven, MSc
Email:
Sub-Investigator
Start date:
December 18, 2023
Completion date:
March 1, 2029
Lead sponsor:
Agency:
Maastricht University Medical Center
Agency class:
Other
Collaborator:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Maastricht University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06082349
https://nlvastudy.com/
