Menu
Not yet recruiting NCT07551063

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

Early Phase I Interventional Hepatic Echinococcosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 5G-based Telerobotic Hepatectomy.
Who it may be relevant to
Registry conditions: Hepatic Echinococcosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluating the Feasibility of 5G-Based Telerobotic Hepatectomy for Hepatic Echinococcosis in High-Altitude Regions: A Prospective, Single-Arm Study

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.

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

  • Procedure 5G-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 trans

Primary outcome measures

  • Technical Success Rate of 5G-based Telerobotic Hepatectomy [Time frame: From the start of the robotic procedure until the completion of the surgery, assessed up to 24 hours.]
Secondary outcome measures (12)
  • Surgical Efficiency -Operative Time [Time frame: From skin incision to skin closure, assessed up to 24 hours.]
  • Intraoperative Safety-Estimated Intraoperative Blood Loss [Time frame: From the start of surgery to the completion of the procedure, assessed up to 24 hours.]
  • Intraoperative Safety-Intraoperative Blood Transfusion Rate [Time frame: From the start of surgery to the completion of the procedure, assessed up to 24 hours.]
  • Rate of Conversion to Open or Laparoscopic Surgery [Time frame: 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 [Time frame: From date of surgery until the date of hospital discharge, assessed up to 60 days.]
  • Postoperative Clinical Recovery-Time to First Postoperative Ambulation [Time frame: From the end of surgery until the first documented ambulation, assessed up to 10 days.]
  • Incidence of Postoperative Complications (Clavien-Dindo Classification) [Time frame: From the end of surgery up to 30 days post-operation.]
  • Tele-Robotic System Performance-Incidence of Robotic Device Defects [Time frame: 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 [Time frame: Continuously during the surgical procedure (approximately 3 to 6 hours).]
  • Surgeon-Perceived Image Quality and Transmission Stability Score [Time frame: Assessed once immediately after the completion of the surgery.]
  • Total NASA Task Load Index (NASA-TLX) Score [Time frame: Within 24 hours after the completion of each surgery.]
  • Textbook Outcome in Liver Surgery (TOLS) [Time frame: Up to 30 days post-operation.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital, Sichuan University — Chengdu

Identifiers

NCT: NCT07551063 · HAT-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗