Меню
Набор скоро начнётся NCT06973083

Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm

Без фазы С лечением Robot Surgery Endoscopic Submucosal Dissection (ESD) Colorectal Neoplasms

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: FASTER-assisted ESD, Conventional ESD.
Кому может быть актуально
Состояния в реестре: Robot Surgery, Endoscopic Submucosal Dissection (ESD), Colorectal Neoplasms. Базовые параметры: 18 лет — 85 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm: A Randomized Controlled Trial.

Обзор

The objective of this study is to investigate the role of the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system in colorectal endoscopic submucosal dissection (ESD) and to validate its superiority over conventional ESD in terms of reducing procedural difficulty, shortening procedure time, and enhancing procedural safety. The main questions it aims to answer are: Does the use of the FASTER system improve the dissection speed of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Does the use of the FASTER system reduce the rate of perforation and hemorrhage, improving the safety of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system. Participants will: Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system. Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. However, ESD is a technically demanding and intricate procedure that requires advanced proficiency of operators, with a heightened risk of complications such as hemorrhage and perforation. The inherent challenges of the colorectal ESD are further amplified by the thin mucosa, highly tortuous and flexible lumen, and occasional obstruction of lesions by mucosal folds, all of which collectively elevate both the procedural difficulty and the probability of postoperative complications. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.

Вмешательства

  • Процедура FASTER-assisted ESD
    The patients who are randomly assigned to the FASTER-assisted ESD group will undergo the ESD procedure with the assistance of the FASTER system.
  • Процедура Conventional ESD
    The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.

Первичные конечные точки

  • procedure time [Срок оценки: Within 24 hours after the procedure.]
Вторичные конечные точки (12)
  • dissection time [Срок оценки: Within 24 hours after the procedure.]
  • dissection speed [Срок оценки: Within 24 hours after the procedure.]
  • en bloc resection rate [Срок оценки: Within 24 hours after the procedure.]
  • R0 resection rate [Срок оценки: Within 24 hours after the procedure.]
  • perforation rate [Срок оценки: Within 24 hours after the procedure.]
  • postoperative hemorrhage rate [Срок оценки: Within 24 hours after the procedure.]
  • intraoperative hemorrhage rate [Срок оценки: Within 24 hours after the procedure.]
  • the proportion of intraoperative hemorrhage ≥ grade 2 [Срок оценки: Within 24 hours after the procedure.]
  • hemostasis time [Срок оценки: Within 24 hours after the procedure.]
  • muscular injury rate [Срок оценки: Within 24 hours after the procedure.]
  • direct-vision dissection rate [Срок оценки: Within 24 hours after the procedure.]
  • postoperative pain score [Срок оценки: 3 days after the procedure.]

Критерии участия

Критерии включения

  • Patients aged 18-85.
  • Patients with pathologically verified colorectal neoplasms scheduled to undergo ESD.

Критерии исключения

  • Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis or other conditions that are not suitable for endoscopic therapy.
  • Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.
  • Patients have a history of colorectal malignancy with previous radiotherapy or operative treatment leading to changes in colorectal structure.
  • Patients have lesions with local recurrence after endoscopic resection.
  • Patients unable to obtain informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Qilu Hospital of Shandong University — Цзинань

Идентификаторы

NCT: NCT06973083 · QLCR20230523

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗