NCT07524699

A Study About Remote and Local Liver Surgery

Efficacy and Safety of MP1000 or MP2000 System in Remote and Local Liver Surgery: A Prospective, Multicenter, Single-blind, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the robotic surgical system producted by Shenzhen Edge Medical Company has a non-inferior surgical success rate in the field of remote liver surgery compared to local surgery. It will also learn about the safety of remote liver surgery. The main questions are: Does remote liver surgery not lower the probability of conversing to open or laparoscopic or local liver surgery? What complications do participants have when taking remote liver surgery? Investigators will compare remote liver surgery to local liver surgery to see if remote liver surgery doesn't lower the surgical conversion rate. Participants will: Undergo remote or local liver surgery according to the random program; Visit the clinic in 3, 28 and 42 day after surgery for checkups and tests; Keep a diary of their postoperative complications.

Detailed description

(1) Background Surgery is an important mean to treat diseases. In recent years, surgical techniques have been developing, evolving from initial open surgery and minimally invasive laparoscopic surgery to current robotic surgery. Surgical robotic systems have been applied in clinical practice for over 20 years and got many excellent results. Compared to traditional laparoscopic surgery, robotic surgery show the following advantages: 1. Provide the surgeons with high-definition and three-dimensional views; 2. The surgical instruments can simulate the flexibility of human fingers and eliminate unnecessary tremors; 3. Surgeons use the control consoles to operate devices like open surgery, which doesn't require long-term learning and training; 4. The surgeons can independently control the endoscopes and surgical instruments, reducing the need of surgical team members and making it easier to achieve the surgeons' intentions; 5. The surgeons operate the systems in sitting positions, which is more easy to perform complex and long time surgery and prolongs the surgeons' surgical life; 6. Patients benefit greatly from this new surgical method for smaller incisions, shorter recovery time, and fewer hospital days. Shenzhen Edge Medical Company has solved many core technologies of robotic surgical system (such as master-slave control strategies, kinematics research, multi-degree-of-freedom simulation manipulators and stereoscopic vision). Beijing Medical Device Inspection Institute has completed the product performance inspection and safety inspection for MP1000 system and MP2000 system. MP1000 system and MP2000 system have completed clinical trials for urology, gynecology, general surgery and thoracic surgery, with a 100% success rate in surgeries. Currently, MP1000 system and MP2000 system have been approved by the National Medical Products Administration (NMPA). Edge Cloud® remote surgery system also had approved by NMPA in November 2025, with the registration number of 20253011753. (2) Practical foundation The development of surgical robot technology and remote communication technology promote the possibility of realizing real-time remote surgery. It allows experts to directly control the surgical robot system to perform surgery from a distance of thousands of kilometers with almost no delay. After rigorous and comprehensive technical verification of remote technology and hundreds of animal experiments, it was initially proved that remote surgery was feasible, safe and effective. With the help of Edge remote surgery team, Dr. Zhang Xu, who was from the General Hospital of the People's Liberation Army, successfully performed remote posterior vena cava ureter repair and formation surgery, radical nephrectomy, partial nephrectomy, radical prostatectomy, and adrenal tumor resection surgery between Beijing and Sanya with a distance of 3,000 kilometers. All surgeries were completed successfully with clear surgical views, flexible robotic arm movements, and without signal delaying. It proved the safety and efficacy of remote surgery. Subsequently, the team of Dr. Zhang Xu successfully completed a randomized controlled clinical trial of local and remote nephrectomy and radical prostatectomy in five locations, including Beijing, Hangzhou, Hefei, Harbin, and Urumqi. The trial confirmed that remote surgery was non-inferior to local surgery in terms of surgical success rate, and there were no significant differences in complications, postoperative recovery, incisal margins, and medical team workloads. In 2025, the team of Chen Xiaoping from the Department of Hepatic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, successfully completed 6 remote liver surgery between Wuhan and Guiyang, spanning a distance of 1,200 kilometers. All surgeries were completed successfully and the trial achieved the expected goal, which preliminarily proved the feasibility and safety of remote liver surgery. However, compared with local liver resection, the issue of whether remote liver resection is non-inferior to local liver resection still needs further research. (3) Practical significance Remote surgery can reduce the difficulty of patients seeking medical treatment in different places and balance the differences of medical level in different regions. It also can provide high-level medical resources in emergencies. (4) Product Structure This system consists of three subsystems: a surgical robot subsystem, a communication subsystem, and a remote conference subsystem. The robot subsystem includes a main doctor control console at the hospital where the surgeon locates, and a bedside control system in the patient's operating room. For safety considerations, a spare doctor control console is set up at the patient's side operating room. In case of a failure of the remote surgery system, the surgeon at the patient's side will take over the surgery and complete the subsequent steps. The communication subsystem consists of routers and communication lines. The remote conference subsystem is responsible for transmitting video and audio between the surgeon and the assistant doctor. All video and audio of the remote surgery are recorded by the subsystem. The video of the local surgery will also be recorded. (5) Working Principle During the surgery, the specialized instruments and endoscope will enter the human body through the channels and reach the surgical area. The image processing platform processes the image signals converts them into stereoscopic image signals. The surgeon at the doctor control console operates the surgical instruments based on the stereoscopic images. The master-slave control system processes the doctor's action signals, then controls the surgical instruments to simulate the surgeon's hand movements and controls the energy excitation of the high-frequency generator connected to the active surgical instruments. The assistant surgeon at the patient's position adjusts the equipment posture, loads and replaces the surgical instruments, loads the endoscope, transmits surgical items, and handles some unexpected emergencies according to the actual clinical needs. The remote surgery is connected to the two robot systems through the remote control platform, using a private network, 5G or broadband network to transmit signals. The surgical doctor controls the local surgical platform at the remote doctor control console to perform the surgery for the patient, while achieving real-time communication between the local end and the remote end. The local doctor control console is connected to the patient's surgical platform and can manually obtain control rights, or automatically obtain control rights in case of remote abnormalities to ensure the completion of the surgery. (6) Emergency Plan For the risks of the control group (the local surgery group), it has been determined that they are not higher than the risk level of conventional medical care. However, the experimental group (the remote surgery group) may have the risks of system failure due to a more complex structure. 1. Remote network anomalies (including abnormal image signals, control instructions, etc.) If the remote network fails and cannot be restored in time, based on the acutal condition, the surgeon beside the patient will decide whether to convert to local surgery. 2. Intraoperative operation anomalies (including unsuccessful hemostasis, unprecise operation, etc.) If the network is normal but cannot be effectively handled the remote end, according to the acutal condition, the surgeon beside the patient should promptly decide whether to convert to local surgery. 3. Remote surgery protection strategy One surgical control console is set up on the remote side and another on the patient side. The backup surgical control console will be used in case of remote surgery system failure and can be used by the surgeon on the patient side to complete all surgical steps. The remote surgery system has been updated based on previous practices and data. The system will monitor real-time network latency. When the network latency exceeds 200 ms, the surgical robot will be locked and the technical team will promptly check the system and network status. (7) Experiment Objective Through this clinical trial, it will evaluate that the MP1000 or MP2000 system has a non-inferior surgical success rate in the field of remote liver surgery compared to local surgeries. (8) Surgical procedures After the remote surgical system is connected, it is necessary to check whether the network bandwidth for data traffic transmission detection is stable and sufficient. The patient would be placed in a supine position (for left hemihepatectomy, left lateral lobectomy, resection of segment 5, regional lymphadenectomy, and biliary exploration, etc.). The camera port was positioned on the upper side of the umbilicus. Subsequently, a carbon dioxide pneumoperitoneum was established and the pressure was maintained at 12 mmHg. The robotic surgical system was docked on the left side of the patient, and the surgical instruments were installed accordingly. Routine abdominal exploration and intraoperative ultrasound examination were carried out. During the procedure, the Pringle's maneuver clamping was routinely performed. An ultrasonic scalpel was used to perform liver parenchymal transection and ligated or clipped any vessels \>2 mm and bile ducts. After hemostasis, the specimen was extracted and one or more drainage tubes were placed on the surface of the raw liver. The surgical team consisted of two surgeons. One served as the console surgeon in the remote end, while the other, the assistant surgeon, was responsible for tasks such as exchanging robotic instruments, delivering surgical supplies, and extracting the specimen in the local end. A spare console was prepared to address potential situations such as communication interruptions, uncontrolled bleeding, or failure of the main console. (9) Evaluation methods 1. Main evaluation indicators 1) Main effectiveness evaluation indicators: Success rate of surgery 2) Main safety evaluation indicators: Incidence of grade 3 and above complications 2. Secondary evaluation indicators 1) Overall functional recovery: 15-item recovery quality scores (QoR-15 scores); 2) Physical activity: 30-second standing up test from a sitting position ; 3) Patient pain score; 4) Surgery-related factors: surgery time, console time, installation time, intraoperative blood loss, intraoperative red blood cell transfusion situation, intraoperative complication; 5) Postoperative conditions: Postoperative complication, postoperative hospital stay days.

Conditions

• Liver Diseases

Interventions

Type	Name	Description
DEVICE	Remote Liver Surgery	The patients in this arm will undergo remote liver surgery.
DEVICE	Local Liver Surgery	The patients in this arm will undergo local liver surgery.

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-12-31
• Completion: 2028-07-31
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: China