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

Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphedema; Lymphedema of Upper Arm; Lymphedema of Limb; Lymphedema, Breast Cancer; Lymphedema of Upper Limb; Lymphedema, Secondary; Lymphedema Arm; Lymphedema; Surgical; Lymphedema, Non-Filarial
• Intervention / Treatment: Device: Lymphaticovenous anastomosis using Microsure Motion Stabilizer; Procedure: Lymphaticovenous anastomosis (manual)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alieske Kleeven, MSc; Phone Number: +31(0)433877481; Email: alieske.kleeven@mumc.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229HX
      • Recruiting
      • Maastricht University Medical Center+
      • Principal Investigator: Shan Shan Qiu Shao, MSc, PhD
      • Contact: Alieske Kleeven, MSc; Phone Number: +31(0)433877481; Email: alieske.kleeven@mumc.nl
      • Sub-Investigator: Tom van Mulken, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: LVA; Lymphovenous bypass; Lymphatic-venous shunt; Lympahticovenular anastomosis; Robot-assisted LVA
Active Comparator: 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.	Procedure: 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; Other Names: LVA; Lymphaticovenous anastomosis; Lymphovenous bypass; Lymphatic-venous shunt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the surgery	The total duaton of the surgery is from the moment of exploration to find adequate lymph channels and venules to the time to finish the LVA anastomoses during surgery. It is hypothesised that robot assisted surgery will have an equal duration of surgery. The increased precision will compensate the initial extra time for settin up the robotic system	Assessed once and registered directly after the surgery
Errors during surgery	The SAMS list of peri-operative 'complications' (technical flaws) are judged by the two blinded consultants. The surgeon and research team will also register a list of peri-operative (technical) problems	Assessed during surgery and registered directly after the surgery on the same day as the surgery
Perioperative complications	The surgeon and research team will register a list of peri-operative complications, as well as complications during the full follow-up period.	Assessed during surgery and postoperatively, in case any occur
Surgeon's satisfaction with the procedure	Is assessed using a ten point Visual Analogue Score. The higher the score, the higher the satisfaction of the surgeon.	Assessed directly after surgery, on the same day as the surgery
Surgeon's learning curve with the procedure in practise	To study the learning curve will be calculated by using a curve fitting method to model learning curves.	Assessed through study completion, an average of 1 year
Patient's convenience during the surgery	Patients' overall convenience during the surgery is assessed using a ten point Visual Analogye Score. The higher the score, the more the patient had experienced during surgery. Moreover, patients are asked to fill in if peculiar matters had occurred which might help to increase the patients overall experience during surgery.	Assessed directly postoperatively,on the same day as the surgery
Arm circumference over time	Arm circumference is assessed by measuring both arms using the Upper Extremity Lymphedema (UEL) index. The arm is measured at 10 and 5 centimeters above and below the elbow, at the elbow, wrist and dorsum of the hand.	At baseline, 3, 6, and 12 months following LVA
Arm volume over time	Water volumetry assess the arm volume over time	At baseline, 3, 6, and 12 months following LVA
Patient's symptoms over time	The Lymphoedema Functioning, Disability and Health (Lymph-ICF) questionnaire assesses physical function, mental function, household activities, mobility activities, and life and social activities. This questionnaire is filled in to evaluate the effect of the LVA surgery and is part of the general evaluation of LVA patients. The questionnaire takes approximately five minutes and consists of 29 questions. The score ranges from 0 to 100, with 0 being the highest healthrelated quality of life.	At baseline, 3, 6 and 12 months following LVA

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Shan Shan Qiu Shao, MSc, PhD, Maastricht University Medical Center; Study Chair: Tom van Mulken, MSc, Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Robot; Robotic-assisted; Robot-assisted; LVA; Microsurgery; Lymphaticovenous anastomosis; Robot-assisted microsurgery; Lymphatico-venular anastomosis
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema; Non-Filarial Lymphedema
• Other Study ID Numbers: NL60199.068.16; METC162053 (Other Identifier: Medical Ethical Committee azM/UM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The results will be published under an Open Access license, making them accesible to everyone at all times. Requests for sharing individual participant data (IPD) will be evaluated on a case-by-case basis, assessing them for suitable research purposes following the trial's completion.
• IPD Sharing 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.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No