Evaluating the Feasibility of 5G-Based Telerobotic Hepatectomy for Hepatic Echinococcosis in High-Altitude Regions: A Prospective, Single-Arm Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Technical Success Rate of 5G-based Telerobotic Hepatectomy
研究概览
简要总结
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.
详细描述
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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Complex cases requiring vascular reconstruction (e.g., advanced alveolar echinococcosis).
- •Severe cardiopulmonary dysfunction or coagulopathy.
- •Pregnancy or lactation.
- •Recent participation in other clinical trials.
研究组 & 干预措施
5G-based Telerobotic Hepatectomy
Participants in this study will undergo radical hepatectomy for hepatic echinococcosis performed via the Toumai™ robotic surgical system. The procedure is executed remotely by expert surgeons at the master console in the hub hospital (Chengdu) who control the robotic arms installed at the remote site hospital (Lhasa). The intervention is facilitated by a dedicated 5G network slicing solution designed to provide ultra-low latency (<50ms) and high-fidelity real-time endoscopic visualization. The surgery is conducted under the support of the SurgSmart AI auxiliary system, with a local bedside surgical team present at the remote site to provide intraoperative assistance and emergency backup, ensuring patient safety throughout the tele-robotic procedure.
干预措施: 5G-based Telerobotic Hepatectomy (Procedure)
结局指标
主要结局
Technical Success Rate of 5G-based Telerobotic Hepatectomy
时间窗: 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.
次要结局
- Surgical Efficiency -Operative Time(From skin incision to skin closure, assessed up to 24 hours.)
- Intraoperative Safety-Estimated Intraoperative Blood Loss(From the start of surgery to the completion of the procedure, assessed up to 24 hours.)
- Intraoperative Safety-Intraoperative Blood Transfusion Rate(From the start of surgery to the completion of the procedure, assessed up to 24 hours.)
- 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.)
- Postoperative Clinical Recovery-Length of Postoperative Hospital Stay(From date of surgery until the date of hospital discharge, assessed up to 60 days.)
- Postoperative Clinical Recovery-Time to First Postoperative Ambulation(From the end of surgery until the first documented ambulation, assessed up to 10 days.)
- Incidence of Postoperative Complications (Clavien-Dindo Classification)(From the end of surgery up to 30 days post-operation.)
- 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.)
- Tele-Robotic System Communication Quality-Average 5G Network Round-Trip Latency(Continuously during the surgical procedure (approximately 3 to 6 hours).)
- Surgeon-Perceived Image Quality and Transmission Stability Score(Assessed once immediately after the completion of the surgery.)
- Total NASA Task Load Index (NASA-TLX) Score(Within 24 hours after the completion of each surgery.)
- Textbook Outcome in Liver Surgery (TOLS)(Up to 30 days post-operation.)
研究者
Hong Wu
Vice President of West China Hospital, Sichuan University
West China Hospital