Modified Double Snare Assisted EMR (mDS-EMR) VS ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm

Официальное название

Comparision of Safety and Efficacy Between Modified Double Snare Assisted EMR (mDS-EMR) and ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm: a Prospective Non-inferiority Randomized Controlled Study

Обзор

The aim of this study is evaluating and safety and efficacy between the modified double snare EMR and ESD. It is intended to prove that for rectal neuroendocrine tumors within 1 cm, the complete resection rate of the mDS-EMR is not inferior to that of ESD, but may with shorter operation time, lower complication rate and lower treatment cost.

Подробное описание

A prospective, single-center, randomized controlled non-inferiority trial was designed to compare the safety and efficacy of modified double snare EMR (mDS-EMR) with endoscopic submucosal dissection (ESD) for the resection of rectal neuroendocrine tumors. The study have 4 main research contents. 1, Whether the resection effect of mDS-EMR is not inferior to that of ESD, and the treatment effect is evaluated by the complete resection rate (R0 resection rate). 2, Whether the operation time of mDS-EMR is significantly shorter than that of ESD. 3, To compare the safety between mDS-EMR and ESD, and whether the mDS-EMR can reduce the risk of intraoperative and postoperative adverse events. 4, To compare the postoperative hospital stay, surgical costs and hospitalization costs between mDS-EMR and ESD.

Вмешательства

• Процедура modified double snare assisted endoscopic mucosal resection
  A polypectomy snare (resection snare) was placed outside of the endoscope. After approaching the lesion, a second polypectomy snare (capture snare) was inserted through the biopsy channel of the endoscope to grasp and lift the lesion. The snare preloaded outside of the endoscope was released, passed through the capture snare and positioned below the capture snare to grasp the base of the lesion. Once the lesion was securely grasped, it was resected by resection snare to achieve en bloc resection
• Процедура endoscopic submucosal dissection
  The procedure includes submucosal injection of normal saline and methylene blue suspension, cutting and dissection by mucosal incision knife (such as Dual knife, Golden knife or Kunpeng knife, etc.) , hemostasis and sealing of the wound. Traction is allowed during the operation.

Первичные конечные точки

• complete resection [Срок оценки: Day 30]

Вторичные конечные точки (6)

• En bloc resection [Срок оценки: Day 30]
• operation success rate [Срок оценки: Periprocedural]
• operation time [Срок оценки: Periprocedural]
• Postoperative hospital stay [Срок оценки: through study completion, an average of 30 days]
• operation-related expenses [Срок оценки: through study completion, an average of 30 days]
• Average hospitalization expenses [Срок оценки: through study completion, an average of 30 days]

Критерии участия

Критерии включения

• Typical rectal neuroendocrine tumors by endoscopy (within 15cm from the anal verge, yellowish subepithelial elevation with a smooth surface, and dilated blood vessels in some areas).
• The maximum diameter of the lesion is smaller than 1cm by preoperative endoscopic assessment.
• Lesion is located within the mucosal and submucosal layer by preoperative endoscopic assessment.
• Patients can understand and sign the informed consent.

Критерии исключения

• Poor coagulation function(PT>15 seconds or APTT>45 seconds or INR>2.0)
• With severe cardiovascular or cerebrovascular diseases and cannot tolerate operation( with a history of stroke or myocardial infarction within the past month or with severe heart failure and cardiac function grade III)
• Indication of metastasis by preoperative imaging examinations
• With more than or equal to 2 rectal neuroendocrine tumors
• With other complications that are not suitable for this study by multidisciplinary team assesment
• Cases of recurrence after operation for neuroendocrine tumors

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: NCT07373015 · 2025-0755 · 2025-LCYJ-MS-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗