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Набор скоро начнётся NCT07551063

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

Ранняя фаза I С лечением Hepatic Echinococcosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 5G-based Telerobotic Hepatectomy.
Кому может быть актуально
Состояния в реестре: Hepatic Echinococcosis. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • West China Hospital, Sichuan University — Чэнду

Идентификаторы

NCT: NCT07551063 · HAT-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗