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

NCT07551063 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: HAT-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Echinococcosis

Keywords

Telerobotic Surgery; Hepatic Echinococcosis; 5G Telemedicine; High-Altitude Medicine

Outcome Measures

Primary Outcomes (1)

• Technical Success Rate of 5G-based Telerobotic Hepatectomy

  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.

  From the start of the robotic procedure until the completion of the surgery, assessed up to 24 hours.

Secondary Outcomes (12)

• 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.

Study Arms (1)

5G-based Telerobotic Hepatectomy

EXPERIMENTAL

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.

Procedure: 5G-based Telerobotic Hepatectomy

Interventions

5G-based Telerobotic Hepatectomy PROCEDURE

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.

5G-based Telerobotic Hepatectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Complex cases requiring vascular reconstruction (e.g., advanced alveolar echinococcosis).
• Severe cardiopulmonary dysfunction or coagulopathy.
• Pregnancy or lactation.
• Recent participation in other clinical trials.

Sponsors & Collaborators

• West China Hospital: lead
• West China Hospital Tibet Hospital, Sichuan University: collaborator

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan / 四川, 614000, China

Location

MeSH Terms

Conditions

Echinococcosis, Hepatic

Condition Hierarchy (Ancestors)

Echinococcosis; Cestode Infections; Helminthiasis; Parasitic Diseases; Infections; Liver Diseases, Parasitic; Liver Diseases; Digestive System Diseases

Central Study Contacts

Qingyun Xie, M.D., Ph.D.

CONTACT

+8618608070908; xieqingyun@stu.scu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of West China Hospital, Sichuan University

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author \[xieqingyun@stu.scu.edu.cn\]. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)