Endoscopic Resection for Small Rectal Neuroendocrine Tumors

Официальное название

Modified Cap-assisted Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection for Small Rectal Neuroendocrine Tumors Less Than 1 cm: a Muticenter Randomized Noninferiority Trial

Обзор

In previous single center study, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic submucosal dissection (ESD) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) and mEMR-C was inferior to ESD for the treatment of small rectal NETs (≤10 mm), as it has shorter operation times and lower hospitalization costs. However, a multicenter randomized controlled trial is needed to prove the universality and generality of these findings.

Подробное описание

Investigators aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with ESD for the treatment of small rectal neuroendocrine tumors (NETs) in six 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 ESD procedure
  ESD was performed as the standard procedure and has been widely described and used. First, dots were marked approximately 5 mm from the periphery of the lesion using coagulation. Subsequently, a diluted sodium hyaluronate solution with indigo carmine dye was injected submucosally. Mucosal incision and submucosal dissection were performed using a T-Type ESD Knife (Micro-Tech, Nanjing, China) or Dual-knife (Olympus Medical, Tokyo, Japan). After resection was completed, all visible vessels on the a

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 75 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 ESD treatment and provide written informed consent;

Критерии исключения

• Unable to tolerate ESD 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: NCT05429216 · NFEC-2022-206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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