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Not yet recruiting Early Phase 1 NCT07551063

5G Remote Robotic Surgery for Hepatic Echinococcosis in High-Altitude Region

Very early trial – mainly for safety
Conditions: Hepatic Echinococcosis

Sponsor: West China Hospital

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Interventions
5G-based Telerobotic Hepatectomy
PROCEDURE
Locations 1
China (1)
West China Hospital, Sichuan University
Chengdu , Sichuan / 四川
Technical details
Status
Not yet recruiting
Phase
Early Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.10.2026
Registry ID
NCT07551063
Source
clinicaltrials.gov
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