Clinical trial NCT06532955: The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema
Official title: Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphedema
Lymphedema Arm
Lymphedema of Upper Arm
Lymphedema of Upper Limb
Lymphedema; Surgical
Lymphedema, Secondary
Lymphedema of Limb
Lymphedema, Breast Cancer
Lymphedema, Non-Filarial
Keywords: Robot-assisted microsurgery
Microsurgery
Robot
Robotic-assisted
Robot-assisted
Lymphaticovenous anastomosis
Lymphatico-venular anastomosis
LVA
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assesses the performance of robot-assisted microsurgery. Lymphaticovenous anastomosis (LVA) is the most difficult procedure in microsurgery at this moment. The LVA technique is applied to treat for example breast cancer-related lymphedema (BCRL). Therefore, this LVA procedure is compared using a manual expert and the same expert applying robot-assisted LVA.

Detailed description: Microsurgery facilitates procedures such as transplantation of tissue as well as lymphedema treatment. Currently, the plastic surgeon's hands are the limiting factor in microsurgical performance. Robot-assistence increases the movement in precision and might therefore be of great importance for the advancement of microsurgery in the world.

It is a prospective study in Maastricht University Medical Center assessing 60 patients undergoing either robot-assisted or manual lymphaticovenous anastomosis (LVA) tot treat breast cancer-related lymphedema (BCRL). The primary outcome parameter is LVA technique. Secondary outcome measures include duration of surgery, technical errors during \& complications peri-operatively, surgeon's satisfaction with the LVA procedure, teh patients' convenience during surgery, arm volume over time and patient's symptoms development over time.

Eligibility criteria: Inclusion Criteria:

* Female gender;
* Treated for primary early stage breast cancer;
* Early stage lymphedema of the arm (stage 1 or 2 on ISL classification);
* ELV \> 10%;
* Suffering from unilateral disease.

Exclusion Criteria:

* Male gender;
* Stage 3 lymphedema of the arm;
* Receiving current breast cancer treatment;
* Distant breast cancer metastases;
* Current substance abuse;
* History of marcaine or indocyanine green allergy;
* Non-viable lymphatic system as determined by near infrared imaging;
* Previous LVA (\<10 years) in the arm with lymphedema.

Primary outcomes:
measure: Efficiency of lymphaticovenous anastomosis (LVA)
timeFrame: Assessed at one moment during, maximally up to 1 year postoperatively
Secondary outcomes:
measure: Duration of the surgery
timeFrame: Assessed once and registered directly after the surgery
measure: Errors during surgery
timeFrame: Assessed during surgery and registered directly after the surgery on the same day as the surgery
measure: Perioperative complications
timeFrame: Assessed during surgery and postoperatively, in case any occur
measure: Surgeon's satisfaction with the procedure
timeFrame: Assessed directly after surgery, on the same day as the surgery
measure: Surgeon's learning curve with the procedure in practise
timeFrame: Assessed through study completion, an average of 1 year
measure: Patient's convenience during the surgery
timeFrame: Assessed directly postoperatively,on the same day as the surgery
measure: Arm circumference over time
timeFrame: At baseline, 3, 6, and 12 months following LVA
measure: Arm volume over time
timeFrame: At baseline, 3, 6, and 12 months following LVA
measure: Patient's symptoms over time
timeFrame: At baseline, 3, 6 and 12 months following LVA
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Shan Shan Qiu Shao, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Tom van Mulken, MSc
role: STUDY_CHAIR
References:
citation: van Mulken TJM, Schols RM, Scharmga AMJ, Winkens B, Cau R, Schoenmakers FBF, Qiu SS, van der Hulst RRWJ; MicroSurgical Robot Research Group. First-in-human robotic supermicrosurgery using a dedicated microsurgical robot for treating breast cancer-related lymphedema: a randomized pilot trial. Nat Commun. 2020 Feb 11;11(1):757. doi: 10.1038/s41467-019-14188-w.
citation: Jonis, Y.M.J., Profar, J. J. A., van Mulken, T. J. M., & Qiu, S. (2023). The MUSA robot and its applicability in lymphatic surgery. Plastic and Aesthetic Research, 10(29), Article A4. https://doi.org/10.20517/2347-9264.2023.06