The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Lymphedema Arm; Lymphedema of Upper Arm; Lymphedema of Upper Limb; Lymphedema, Breast Cancer; Lymphedema, Secondary; Lymphedema; Lymphedema, Non-Filarial; Lymphedema of Limb; Lymphedema; Surgical

Treatments: Device: Lymphaticovenous anastomosis using Microsure Motion Stabilizer; Procedure: Lymphaticovenous anastomosis (manual)

Study type: Interventional

Funder types: Other

Identifiers

NCT06532955

NL60199.068.16

METC162053 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Lymphaticovenous anastomosis using Microsure Motion Stabilizer

Experimental group

Description:

Patients in this group undergo robot-assisted lymphaticovenous anastomosis at one or more locations on the affected arm. The procedure is performed under local anesthesia. Incisions are made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The location(s) are determined prior to surgery using ICG lymphography. LVA(s) are made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVAs are madeusing a surgical microscope and the operation takes approximately 240 minutes.

Treatment:

Device: Lymphaticovenous anastomosis using Microsure Motion Stabilizer

Lymphaticovenous anastomosis

Active Comparator group

Description:

Patients in this group undergo lymphaticovenous anastomosis at one or more locations on the affected arm. The procedure is performed under local anesthesia. Incisions are made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The location(s) are determined prior to surgery using ICG lymphography. LVA(s) are made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVAs are madeusing a surgical microscope and the operation takes approximately 90 minutes.

Treatment:

Procedure: Lymphaticovenous anastomosis (manual)