Hepatic Echinococcosis
Conditions
Keywords
Telerobotic Surgery, Hepatic Echinococcosis, 5G Telemedicine, High-Altitude Medicine
Brief summary
Hepatic echinococcosis (HE) is a serious endemic parasitic disease in high-altitude regions like Xizang. Radical hepatectomy is the primary curative treatment, but expert resources are often concentrated in large medical centers. This prospective, single-arm study aims to evaluate the feasibility and safety of performing remote robotic hepatectomy using the Chinese Toumai™ robotic system over a 5G network. Ten patients in West China Hospital Tibet Hospital, Sichuan University (Lhasa, 3650m altitude) will undergo surgery performed by expert surgeons at West China Hospital (Chengdu). The primary focus is the surgical success rate and perioperative safety.
Detailed description
This study aims to evaluate the feasibility and safety of performing radical hepatectomy for hepatic echinococcosis in a high-altitude region (Lhasa, Xizang, 3650m altitude) utilizing the domestic Toumai™ robotic surgical system via 5G network communication. Hepatic echinococcosis is a significant endemic parasitic disease in high-altitude areas. While radical resection remains the definitive treatment, a disparity in the distribution of expert surgical resources poses challenges to patient access. This prospective study investigates the following: Technical Feasibility: To validate whether the 5G network performance, specifically regarding latency and image resolution in a high-altitude and long-distance transmission environment, meets the clinical requirements for real-time robotic surgery. 1. Operational Safety: To assess the impact of tele-robotic control on the precision required for complex hepatic procedures, such as managing critical vascular structures and dissecting cystic walls. 2. Clinical Outcomes: To analyze the efficacy and non-inferiority of the tele-robotic approach compared to traditional surgical methods by evaluating perioperative technical metrics and postoperative recovery indices. By establishing a closed-loop surgical connection between the center (Chengdu) and the remote site (Lhasa), the team will monitor real-time tele-interaction stability. This study includes robust contingency protocols for network instability or mechanical failure to ensure patient safety, providing clinical evidence for the standardization of remote hepatobiliary surgery in underserved regions.
Interventions
PROCEDURE5G-based Telerobotic Hepatectomy
Participants will undergo a radical hepatectomy for hepatic echinococcosis using the domestic Toumai™ robotic surgical system. The procedure is performed via a tele-robotic approach, where the lead surgeon operates from a remote console at the hub hospital (Chengdu) to control robotic arms positioned at the remote site (Lhasa). The intervention is integrated with a dedicated 5G network slicing solution designed to maintain ultra-low latency (\<50ms) and high-fidelity 4K 3D endoscopic video transmission, ensuring real-time synchronization between the surgeon's input and mechanical response. The procedure also incorporates the SurgSmart AI auxiliary system for real-time anatomical identification, and is supported by a local bedside surgical team at the remote site who provide intraoperative assistance and emergency backup, maintaining a standardized clinical workflow for complex tele-robotic liver resections.
Sponsors
West China Hospital
West China Hospital Tibet Hospital, Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The intervention utilizes the Toumai™ multi-port robotic system integrated with a dedicated 5G network slicing solution to ensure ultra-low latency (\<50ms). Surgeons at the master console in Chengdu perform real-time procedures via a hand-eye coordination interface, controlling robotic arms at the remote site in Lhasa. The model incorporates the SurgSmart AI system for intraoperative anatomical identification and a bidirectional audio-video link for hub-remote collaboration. A robust safety protocol is implemented, featuring an emergency lock mechanism and a trained local bedside team capable of taking over the procedure within 5 seconds in the event of network instability or mechanical failure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-80 years. * Diagnosed with hepatic echinococcosis with indications for hepatectomy. * Suitable for laparoscopic/robotic surgery (Child-Pugh Class A or B). * Voluntary signed informed consent.
Exclusion criteria
* Complex cases requiring vascular reconstruction (e.g., advanced alveolar echinococcosis). * Severe cardiopulmonary dysfunction or coagulopathy. * Pregnancy or lactation. * Recent participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate of 5G-based Telerobotic Hepatectomy | From the start of the robotic procedure until the completion of the surgery, assessed up to 24 hours. | Technical success is defined as the successful completion of the pre-planned radical resection of hepatic echinococcosis using the Toumai™ robotic surgical system, strictly adhering to the following criteria: (1) no intraoperative conversion to open surgery due to system failure or technical complications; (2) no intraoperative damage to critical vascular or biliary structures attributed to robotic system latency or mechanical malfunction; (3) no requirement for emergency manual intervention by the bedside team to rectify system-related issues; and (4) the successful completion of the target procedure within the standardized operative time framework. This metric serves as the primary indicator for evaluating the operational feasibility and safety of the 5G telerobotic model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Efficiency -Operative Time | From skin incision to skin closure, assessed up to 24 hours. | Total time elapsed from the first skin incision to the completion of skin closure, measured in minutes. |
| Intraoperative Safety-Estimated Intraoperative Blood Loss | From the start of surgery to the completion of the procedure, assessed up to 24 hours. | Total volume of blood lost during the surgical procedure, calculated by measuring the volume in the suction canisters and the weight increase of surgical gauzes (1 gram = 1 milliliter). |
| Intraoperative Safety-Intraoperative Blood Transfusion Rate | From the start of surgery to the completion of the procedure, assessed up to 24 hours. | The percentage of participants who required an allogeneic blood transfusion during the surgical procedure. |
| Rate of Conversion to Open or Laparoscopic Surgery | From the start of the robotic procedure until the completion of the surgery, assessed up to 24 hours. | The percentage of cases where the telerobotic procedure could not be completed as planned and required conversion to traditional open surgery or conventional laparoscopy due to technical or safety reasons. |
| Postoperative Clinical Recovery-Length of Postoperative Hospital Stay | From date of surgery until the date of hospital discharge, assessed up to 60 days. | The total number of days from the date of surgery to the date of hospital discharge. |
| Postoperative Clinical Recovery-Time to First Postoperative Ambulation | From the end of surgery until the first documented ambulation, assessed up to 10 days. | The time interval from the end of the surgical procedure to the moment the patient first stands and walks independently or with minimal assistance, measured in hours. |
| Incidence of Postoperative Complications (Clavien-Dindo Classification) | From the end of surgery up to 30 days post-operation. | The percentage of participants experiencing one or more postoperative complications within 30 days, graded according to the Clavien-Dindo classification system (ranging from Grade I to Grade V). |
| Tele-Robotic System Performance-Incidence of Robotic Device Defects | From the start of the robotic procedure until the completion of the surgery, assessed up to 24 hours. | The number of technical incidents related to the Toumai™ robotic system, including both mechanical malfunctions and software failures, that occur during the procedure. |
| Tele-Robotic System Communication Quality-Average 5G Network Round-Trip Latency | Continuously during the surgical procedure (approximately 3 to 6 hours). | The mean duration of data transmission delay between the hub (Chengdu) and the remote site (Lhasa), measured in milliseconds (ms) using real-time network monitoring tools. |
| Surgeon-Perceived Image Quality and Transmission Stability Score | Assessed once immediately after the completion of the surgery. | A subjective evaluation performed by the remote surgeon using a Likert scale (ranging from 1 = Poor to 5 = Excellent) to assess the 3D endoscopic image resolution and the stability of the video feed during the procedure. |
| Total NASA Task Load Index (NASA-TLX) Score | Within 24 hours after the completion of each surgery. | The overall cognitive and physical workload of the remote surgeon assessed using the NASA Task Load Index (NASA-TLX) questionnaire. Six subscales (Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration) are rated on a scale of 0-100 and then aggregated into a single weighted average score (ranging from 0 to 100), where higher scores indicate a higher workload. |
| Textbook Outcome in Liver Surgery (TOLS) | Up to 30 days post-operation. | TOLS is a composite measure representing the optimal surgical result. It is defined as a case meeting all the following criteria: no intraoperative grade III or higher complications, R0 resection margin (no tumor cells at the margin), no prolonged hospital stay, no 30-day readmission, and no 30-day mortality. This provides a holistic view of the quality of the 5G-based telerobotic radical hepatectomy. |
Countries
China
Contacts
CONTACTQingyun Xie, M.D., Ph.D.
Outcome results
None listed