Efficacy and Safety Research of Cold Snare Polypectomy and Hot Snare Polypectomy in the Treatment of 4-9 mm Diameter Colorectal 0-Isp and 0-Ip Polyps: a Prospective, Multicenter, Randomized Controlled Study(FAST -REST Study)

Обзор

This study will evaluate the efficacy and safety of cold snare polypectomy(CSP) and hot snare polypectomy(HSP) in the treatment of colorectal 4-9mm 0-Isp and 0-Ip polyps, and compare the complete resection rate, postoperative late bleeding rate, intraoperative bleeding rate, en bloc resection rate, operation time and the number of metal clips used. The conclusion of this study will help clinical doctor develop more effective resection strategies for colorectal 0-Isp and 0-Ip polyps, and provide more effective treatment for patients.

Подробное описание

Colorectal polyps are one of the precancerous lesions of colorectal cancer, 60-80% of which eventually become advanced colorectal cancer. Therefore, early resection of colorectal polyps can effectively reduce the incidence of colorectal cancer. Polyps under white light are judged mainly according to the shape, size and color of polyps. At present, the Paris classification is often used to divide 0-I uplifted polyps into sessile polyps (0-Is), sessile-pedunculated polyps (0-Isp) and pedunculated polyps (0-Ip). It is generally believed that there are thick arteries in 0-Ip polyps, especially thick pedunculated polyps, which are prone to uncontrollable bleeding during operation. 0-Is polyps have small scattered blood vessels and low intraoperative bleeding risk, while the morphological and structural characteristics of 0-Isp polyps are between the two. The current guidelines recommend HSP for 0-Isp and 0-Ip polyps \<1 cm, but the internal blood vessels of these polyps are not thick. There is no guidance on whether they can be resected by CSP method, and there is a lack of prospective large sample clinical research. This study will include0-Isp /0-Ip polyps \<1cm, and observe the safety and effectiveness of CSP for the above polyp resection , so as to provide reference for the clinical treatment of colorectal polyps.

Вмешательства

• Процедура cold snare polypectomy
  Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge. Tighten the snare at a constant speed and gently lift it up and then excision.
• Процедура hot snare polypectomy
  According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection. Tighten the snare at a constant speed and gently lift it up.Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off.

Первичные конечные точки

• Complete resection rate [Срок оценки: Up to 5-7 days from operation day]

Вторичные конечные точки (6)

• Postoperative delayed bleeding rate [Срок оценки: Up to 14 days from operation day]
• Intraoperative bleeding rate [Срок оценки: Up to 1 minute from the time the polyp is resected]
• En bloc resection rate [Срок оценки: Up to 7 days when the pathologists finish the evaluations.]
• Operation time [Срок оценки: From the snare/ injection needle exits the working channel to leaving the wound.]
• Other related postoperative complications [Срок оценки: Up to 48 Hours from the time the polyp is resected]
• Number of metal clips used [Срок оценки: The time when the operation is completed]

Критерии участия

Критерии включения

• Age: 18-80 years old, male or female
• At least one polyp with size of 4-9 mm 0-Isp or 0-Ip is found during colonoscopy
• Voluntarily sign informed consent for endoscopic treatment

Критерии исключения

• Boston Bowel Preparation Scale<6 points.
• Patients who receive antiplatelet/anticoagulant therapy within 5 days before polypectomy.
• Participants with a contraindication to colonoscopy and polypectomy.
• Patients with inflammatory bowel disease or gastrointestinal polyposis.
• Lesions with submucosal invasion and those suspected of being cancerous at the preprocedural diagnostic evaluation.
• Patients with pregnancy.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University — Шанхай

Идентификаторы

NCT: NCT06658561 · RuijinH20241532

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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