A Study About Remote and Local Liver Surgery

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

The goal of this clinical trial is to learn if the robotic surgical system producted by Shenzhen Edge Medical Company has a non-inferior textbook outcome in liver surgery in the field of remote surgery compared to local robotic surgery. It will also learn about the safety of remote liver surgery.

The main questions are: Does remote liver surgery not lower the textbook outcomes in liver surgery compared to the local robotic surgery? What complications do participants have when taking remote liver surgery? Investigators will compare remote liver surgery to local robotic liver surgery to see if remote liver surgery doesn't lower the textbook outcome in liver surgery.

Participants will:

Undergo remote or local robotic 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Diseases
• Intervention / Treatment: Device: Local Liver Surgery; Device: Remote Liver Surgery

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.

MP1000 system has completed clinical trials for urology, gynecology, general surgery and thoracic surgery, with a 100% success rate in surgeries. Currently, MP1000 system has 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 system has a non-inferior textbook outcome in liver surgery in the field of remote surgery compared to local robotic surgery.

(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: Textbook outcome in liver surgery
2. Secondary evaluation indicators 1) Surgical success rate; 2) Overall functional recovery: 15-item recovery quality scores (QoR-15 scores); 3) Physical activity: 30-second standing up test from a sitting position ; 4) Patient pain score; 5) Surgery-related factors: surgery time, console time, installation time, intraoperative blood loss, intraoperative red blood cell transfusion situation, intraoperative complication; 6) Postoperative conditions: Postoperative complication, postoperative hospital stay days.

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peng Zhu, Medicine Doctor; Phone Number: +86-13907170712; Email: zhupeng@medmail.com.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Peng Zhu, Medicine Doctor; Phone Number: +86-13907170712; Email: zhupeng@medmail.com.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age range: 18-75 years old (inclusive), gender not restricted;
2. BMI: 18-30 Kg/m2;
3. Relevant indications for liver surgery;
4. Physiological condition allows for laparoscopic surgery, and the Iwate score for laparoscopic difficulty of the enrolled patients is ≤ 6;
5. Willing to cooperate and complete follow-up and related subsequent examinations;
6. Voluntary to sign the informed consent form;
7. Indocyanine green 15-minute retention rate (ICG-R15) < 15%, and liver function Child-Pugh grade is A.

Exclusion Criteria:

1. Patients with severe circulatory system diseases who cannot tolerate surgery;
2. Pregnant or lactating women;
3. Patients with a history of epilepsy or mental illness;
4. Patients with severe allergic constitution and those suspected or diagnosed with alcohol or drug addiction;
5. Patients who cannot understand the research requirements or who cannot complete the research follow-up;
6. Patients considered unsuitable to participate in this trial by the researchers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local Surgery; The patients in this arm (group) will undergo local liver surgery according to random allocation.	Device: Local Liver Surgery; The patients in this arm will undergo local liver surgery.
Experimental: Remote Surgery; The patients in this arm (group) will undergo remote liver surgery according to random allocation.	Device: Remote Liver Surgery; The patients in this arm will undergo remote liver surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Textbook outcome in liver surgery	The textbook outcome in liver surgery is defined as the absence of intraoperative incidents of grade 2 or higher (defined according to the Oslo classification), postoperative bile leak of grade B or C (according to the severity grading of the International Study Group of Liver Surgery),30 severe complications (Clavien-Dindo grade III or higher), postoperative reintervention (ie, surgical, endoscopic, or radiologic), readmission within 30 days after discharge, in-hospital mortality, and the presence of R0 resection margin (ie, 1 mm or more tumor-free margin).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss		During surgery
Mortality		6 weeks
Incidence of adverse events		6 weeks
Overall complication rate		6 weeks
Operation Time		During surgery
Console Time		During surgery
Positive Margin rate	This outcome is judged by a pathologist. For the time constraints for preparing the pathological slides, the result usually will be available in one week after the surgery.	In one week after surgery
Patient pain score	The pain score is from 0 to 10. Score 0 means no pain and score 10 means the most intense pain. Score 1-3 means mild pain and does not affects sleeping. Score 4-6 means moderate pain and may affect sleeping. Score 7-10 means severe pain and seriously affects sleeping and quality of life. A higher score means a worse result.	6 weeks
Doctor satisfaction	Doctor satisfaction consists of 6 outcomes: 1) mental demands, 2) physical demands, 3) temporal demands, 4) performance, 5) effort and 6) difficulty. All the score are from 1 to 21. Score 1 means very low and score 21 means very high. The higher score in the result means more needs or difficulty in this evaluation. A higher score means a worse result.	1 week
Postoperative hospital stay		4 weeks
Blood transfusion rate		6 weeks
Readmission rate		6 weeks
Reoperation rate		6 weeks
Incidence of device defects		6 weeks
Incidence of serious adverse events		6 weeks
Remote operation evaluation	The evaluations includes latency and stability evaluation, interaction evaluation, endoscopic image evaluation and operational stability evaluation. Every subevaluation score is from 1 to 5. Score 5: Very satisfied, meeting all clinical needs. Score 4: Quite satisfied, meeting most clinical needs. Score 3: Score 3: basically satisfied, meeting the minimum clinical needs. Score 2: Quite unsatisfied, unable to meet the minimum clinical needs. Score 1: Very unsatisfied, completely unable to operate. The higher score means more satisfaction to the subevaluation and a better outcome.	In one week after surgery.
Surgery Success rate	The number of subjects who successfully completed remote surgical treatment using the experimental equipment, as a proportion of the total number of subjects. The definition of a successful surgery: (a) The surgical process was completed according to the original plan; (b) There was no conversion of surgical methods, such as remote-local, remote-laparoscopic/open; (c) There was no delay due to failure of the surgical system. Whether each case was successful should be confirmed by the medical team after the surgery based on the pre-set criteria for judgment.	1 day

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: The First Affiliated Hospital of Anhui Medical University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Zhujiang Hospital; The Affiliated Hospital Of Guizhou Medical University; Wuhan TongJi Hospital; First Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Chengdu Medical College; Affiliated Hospital of Qinghai University; First Affiliated Hospital of Guangxi Medical University; The First Medical Center of Chinese PLA General Hospital; Xinqiao Hospital, Amry Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 16, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: March 28, 2026
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Liver Surgery; Remote Surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: Remote Liver Surgery-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If the readers want to learn more about the study, please send an e-mail to Doctor Peng Zhu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No