Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Maastricht University Medical Center
RECRUITING
Maastricht
Radboud University Medical Center
RECRUITING
Nijmegen
Erasmus University Medical Center
NOT_YET_RECRUITING
Rotterdam
Contact Information
Primary
Alieske Kleeven, MSc
alieske.kleeven@mumc.nl
+31(0)433877481
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2029-03-01
Participants
Target number of participants: 110
Treatments
Experimental: Lymphaticovenous anastomosis (LVA)
Patients in this group will undergo lymphaticovenous anastomosis at one or more locations on the affected limb, and the procedure will be performed under local anesthesia. During the operation, patients will be blinded using a noise-canceling headphone and blindfolds. Incisions will be made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lympahtic system. The locations will be determined prior to the surgery using ICG lymphography. The LVA(s) will be made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVA(s) is made using a surgical microscope and the operation will take approximately 60 to 90 minutes.
Sham_comparator: Sham surgery
Patients in this group will undergo sham surgery at one location on the affected limb, and the procedure will be performed under local anesthesia. During the operation, patients will be blinded using a noise-canceling headphone and blindfolds. The locations for LVA surgery will be determined prior to the surgery using ICG lymphography. However, the incision for the sham procedure will be made 2 centimeters medial or lateral to the predetermined site. This is done in order to avoid damage to the lymph vessels as to allow for future LVA surgery. After the incision, no LVA is made. Rather than performing the actual operation, the plastic surgeon will simulate the procedure by applying pressure in the surgical area. To mimic the approximate duration of a regular LVA procedure, the sham operation will take approximately 60 to 90 minutes.
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center
Collaborators: Radboud University Medical Center, Erasmus Medical Center

This content was sourced from clinicaltrials.gov