Endoscopic Resection for Small Rectal Neuroendocrine Tumors

Официальное название

Modified Cap-assisted Endoscopic Mucosal Resection and Modified Endoscopic Mucosal Resection with a Ligation Device for Small Rectal Neuroendocrine Tumors Less Than 1 Cm: a Muticenter Randomized Noninferiority Trial

Обзор

According to clinical practice and relevant retrospective research data, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic mucosal resection with a ligation device(ESMR-L) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) . However, there is a lack of multicenter prospective studies to evaluate the advantages and disadvantages of mEMR-C and mEMR-L. mEMR-C is the modified ESMR-L without submucosal injection.

Подробное описание

We aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with mEMR-L for the treatment of small rectal neuroendocrine tumors (NETs) in ten tertiary hospitals in China.

Вмешательства

• Процедура mEMR-C procedure
  A transparent cap with an inner groove (MH-593; Olympus, Tokyo, Japan) was attached to the forward-viewing colonoscope. After the endoscope was inserted into the rectum, a crescent-shaped electrosurgical snare was passed through the sheath and looped along the inner groove of the cap. Submucosal injections were not required in this method. The tumor was suctioned into the cap and grasped by tightening the snare. After confirming the appropriate snare placement, both the tumor and overlying mucos
• Процедура mEMR-L procedure
  First, install the ligation device (provided by Jiangsu Gerrit) at the front end of the endoscope. After inserting the endoscope into the rectum, suck the lesion into the ligation device, release the ligator to ligate the lesion. Then, use a snare to resect the lesion below the ligator. Finally, uniformly suture the wound surface with metal clips.

Первичные конечные точки

• histological complete resection [Срок оценки: within 14 days after procedure]

Вторичные конечные точки (8)

• success rate of operation [Срок оценки: intraoperative]
• en bloc resection [Срок оценки: intraoperative]
• operation time [Срок оценки: intraoperative]
• complications [Срок оценки: within 14 days after procedure]
• length of stay [Срок оценки: within 14 days after procedure]
• hospitalization cost [Срок оценки: within 14 days after procedure]
• operation cost [Срок оценки: within 14 days after procedure]
• histopathologic grade [Срок оценки: within 14 days after procedure]

Критерии участия

Критерии включения

• Age from 18 to 80 years;
• With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy;
• With tumor size ≤10 mm assessed by colonoscopy;
• Plan to receive mEMR-C or mEMR-L treatment and provide written informed consent;

Критерии исключения

• Unable to tolerate mEMR-L or mEMR-C as assessed by the research team of each center;
• Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation;
• Rectal NET with lymph node metastasis or distant metastasis;
• Received resection of rectal neuroendocrine tumor by other surgical procedures;
• Multiple rectal neuroendocrine tumors;
• Vulnerable groups such as pregnant women or patients with mental disorders;
• Poor compliance, unable to cooperate with treatment.

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06901856 · KY2025-063-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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