Hepatic EchinococcosisEarly Phase 1HATNCT07551063
5G Remote Robotic Surgery for Hepatic Echinococcosis in High-Altitude Region
A Early Phase 1 study testing 5G-based Telerobotic Hepatectomy in people with Hepatic Echinococcosis, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Echinococcosis
- What is being tested?
- 5G-based Telerobotic Hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Complex cases requiring vascular reconstruction (e.g., advanced alveolar echinococcosis).
- Severe cardiopulmonary dysfunction or coagulopathy.
- Pregnancy or lactation.
- Recent participation in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital, Sichuan University
Chengdu, Sichuan / 四川, 614000
Qingyun Xie, 18608070908, xieqingyun@stu.scu.edu.cn
Hong Wu, M.D., Ph.D., +86-18323424347, caiyunshi@scu.edu.cn
About this study
Official title: Evaluating the Feasibility of 5G-Based Telerobotic Hepatectomy for Hepatic Echinococcosis in High-Altitude Regions: A Prospective, Single-Arm Study
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.
Read the 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.
- 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.
- Conditions
- Hepatic Echinococcosis
- Being tested
- 5G-based Telerobotic Hepatectomy
- Keywords
- Telerobotic Surgery, Hepatic Echinococcosis, 5G Telemedicine, High-Altitude Medicine
- Medical subject headings
- Echinococcosis, Hepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5G-based Telerobotic HepatectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 5G-based Telerobotic Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Total time elapsed from the first skin incision to the completion of skin closure, measured in minutes.
Measured: From skin incision to skin closure, assessed up to 24 hours.
Intraoperative Safety-Estimated Intraoperative Blood Loss
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).
Measured: From the start of surgery to the completion of the procedure, assessed up to 24 hours.
Intraoperative Safety-Intraoperative Blood Transfusion Rate
The percentage of participants who required an allogeneic blood transfusion during the surgical procedure.
Measured: From the start of surgery to the completion of the procedure, assessed up to 24 hours.
Rate of Conversion to Open or Laparoscopic Surgery
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.
Measured: 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
The total number of days from the date of surgery to the date of hospital discharge.
Measured: From date of surgery until the date of hospital discharge, assessed up to 60 days.
Postoperative Clinical Recovery-Time to First Postoperative Ambulation
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.
Measured: From the end of surgery until the first documented ambulation, assessed up to 10 days.
Incidence of Postoperative Complications (Clavien-Dindo Classification)
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).
Measured: From the end of surgery up to 30 days post-operation.
Tele-Robotic System Performance-Incidence of Robotic Device Defects
The number of technical incidents related to the Toumai™ robotic system, including both mechanical malfunctions and software failures, that occur during the procedure.
Measured: 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
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.
Measured: Continuously during the surgical procedure (approximately 3 to 6 hours).
Surgeon-Perceived Image Quality and Transmission Stability Score
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.
Measured: Assessed once immediately after the completion of the surgery.
Total NASA Task Load Index (NASA-TLX) Score
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.
Measured: Within 24 hours after the completion of each surgery.
Textbook Outcome in Liver Surgery (TOLS)
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.
Measured: Up to 30 days post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EchinococcosisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital Tibet Hospital, Sichuan University
- Responsible party
- Principal investigator, Hong Wu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551063
- Sponsor's protocol ID
- HAT-001
- Acronym
- HAT
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of 5G-Based Telerobotic Hepatectomy for Hepatic Echinococcosis in High-Altitude Regions: A Prospective, Single-Arm Study
- ClinicalTrials.gov ID
- NCT07551063
- Acronym / sponsor ID
- HAT / HAT-001
- Conditions
- Hepatic Echinococcosis
- Keywords
- Telerobotic Surgery, Hepatic Echinococcosis, 5G Telemedicine, High-Altitude Medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- West China Hospital Tibet Hospital, Sichuan University
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 5G-based Telerobotic Hepatectomy | Experimental | Procedure: 5G-based Telerobotic HepatectomyParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Complex cases requiring vascular reconstruction (e.g., advanced alveolar echinococcosis).
- Severe cardiopulmonary dysfunction or coagulopathy.
- Pregnancy or lactation.
- Recent participation in other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5G-based Telerobotic HepatectomyParticipants 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. | Procedure or surgery | 5G-based Telerobotic Hepatectomy |
Primary outcome
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.
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.
12 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 5G-based Telerobotic Hepatectomy in people with Hepatic Echinococcosis, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingyun Xie, M.D., Ph.D. (+8618608070908, xieqingyun@stu.scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.