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

NCT06532955 | Recruiting DMC

• 2 other identifiers: NL60199.068.16METC162053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Efficiency of lymphaticovenous anastomosis (LVA)

  Efficiency of LVA is measured assessing the quality of the LVA using video recordings of the surgery, which is judged by two independent consultants. The Structured Assessment of Microsurgery Skills (SAMS) measuring method is used to assess the quality of each anastomosis. The SAMS score contains twelve separate items, scored from 1 (bad) to 5 (excellent), grouped into four areas (dexterity, visuo-spatial ability, operative flow and judgement), each subdivided into three technical components.

  Assessed at one moment during, maximally up to 1 year postoperatively

Secondary Outcomes (9)

• Duration of the surgery

  Assessed once and registered directly after the surgery

• Errors during surgery

  Assessed during surgery and registered directly after the surgery on the same day as the surgery

• Perioperative complications

  Assessed during surgery and postoperatively, in case any occur

• Surgeon's satisfaction with the procedure

  Assessed directly after surgery, on the same day as the surgery

• Surgeon's learning curve with the procedure in practise

  Assessed through study completion, an average of 1 year

Study Arms (2)

Lymphaticovenous anastomosis using Microsure Motion Stabilizer

EXPERIMENTAL

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.

Device: Lymphaticovenous anastomosis using Microsure Motion Stabilizer

Lymphaticovenous anastomosis

ACTIVE COMPARATOR

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.

Procedure: Lymphaticovenous anastomosis (manual)

Interventions

Lymphaticovenous anastomosis using Microsure Motion Stabilizer 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.

Also known as: LVA, Lympahticovenular anastomosis, Lymphovenous bypass, Lymphatic-venous shunt, Robot-assisted LVA

Lymphaticovenous anastomosis using Microsure Motion Stabilizer

Lymphaticovenous anastomosis (manual) 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

Also known as: LVA, Lymphaticovenous anastomosis, Lymphovenous bypass, Lymphatic-venous shunt

Lymphaticovenous anastomosis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with breast cancer-related lymphedema
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229HX, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 32047155 RESULT

• 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

  RESULT

MeSH Terms

Conditions

Lymphedema; Neoplasm Metastasis; Breast Cancer Lymphedema; Non-Filarial Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Shan Shan Qiu Shao, MSc, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Tom van Mulken, MSc

  Maastricht University Medical Center

  STUDY CHAIR

Central Study Contacts

Alieske Kleeven, MSc

CONTACT

+31(0)433877481; alieske.kleeven@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: August 1, 2024
• Study Start: June 1, 2017
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will become available upon request after the completion of the trial and publication of primary manuscripts. Individual participant data will be stored for a period of 15 years.
• Access Criteria: Request for data sharing of individual participant data (IPD) will be assessed individuallyn by the principal investigator, considering them for appropriate research purposes after the completion of the trial

Locations

NL (1)