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

NCT ID: NCT06532955

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2026-01-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lymphaticovenous anastomosis using Microsure Motion Stabilizer

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.

Group Type: EXPERIMENTAL

Lymphaticovenous anastomosis using Microsure Motion Stabilizer

Intervention Type: DEVICE

The robot-assisted LVA is performed using the Microsure Motion Stabilizer, a telemanipulation tool that stabilizes a surgeon's movement during open microsurgical operations on extremities, specifically on veins and nerves that are close to the skin.

The surgeon controls a joystick, which directly copies the surgeon's movements in real-time to an instrument held by the device. The device's software scales down the motions and filters out tremor. Surgical technique and method of treatment are identical to conventional microsurgery. The device is equipped with genuine microsurgical instruments and is compatible with existing surgical microscopes. Instead of holding the instrument directly in hand, which is limited in precision and dexterity, the surgeon operates while the instrument's movements are stabilized. The modular design allows the surgeon to decide what level of manipulation assistance is required during a certain procedure.

Lymphaticovenous anastomosis

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.

Group Type: ACTIVE_COMPARATOR

Lymphaticovenous anastomosis (manual)

Intervention Type: PROCEDURE

Lymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to an adjacent vein of similar size, thereby facilitating the outflow of lymphatic fluid in patients suffering from secondary lymphedema

Interventions

Lymphaticovenous anastomosis using Microsure Motion Stabilizer

The robot-assisted LVA is performed using the Microsure Motion Stabilizer, a telemanipulation tool that stabilizes a surgeon's movement during open microsurgical operations on extremities, specifically on veins and nerves that are close to the skin.

The surgeon controls a joystick, which directly copies the surgeon's movements in real-time to an instrument held by the device. The device's software scales down the motions and filters out tremor. Surgical technique and method of treatment are identical to conventional microsurgery. The device is equipped with genuine microsurgical instruments and is compatible with existing surgical microscopes. Instead of holding the instrument directly in hand, which is limited in precision and dexterity, the surgeon operates while the instrument's movements are stabilized. The modular design allows the surgeon to decide what level of manipulation assistance is required during a certain procedure.

Intervention Type: DEVICE

Lymphaticovenous anastomosis (manual)

Lymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to an adjacent vein of similar size, thereby facilitating the outflow of lymphatic fluid in patients suffering from secondary lymphedema

Intervention Type: PROCEDURE

Other Intervention Names

LVA; Lympahticovenular anastomosis; Lymphovenous bypass; Lymphatic-venous shunt; Robot-assisted LVA; LVA; Lymphaticovenous anastomosis; Lymphovenous bypass; Lymphatic-venous shunt

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shan Shan Qiu Shao, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Tom van Mulken, MSc

Role: STUDY_CHAIR

Maastricht University Medical Center

Locations

Maastricht University Medical Center+

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Alieske Kleeven, MSc

Role: CONTACT

alieske.kleeven@mumc.nl

+31(0)433877481

Facility Contacts

Alieske Kleeven, MSc

Role: primary

alieske.kleeven@mumc.nl

+31(0)433877481

References

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.

Reference Type: RESULT

PMID: 32047155 (View on PubMed)

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

Reference Type: RESULT

Other Identifiers

METC162053

Identifier Type: OTHER

Identifier Source: secondary_id

NL60199.068.16

Identifier Type: -

Identifier Source: org_study_id