Cold Snare Versus Cold Forceps Polypectomy for Small Lesions

Официальное название

Cold SNAre Versus Cold forcePS Polypectomy for Small Colorectal Lesions (Cold-SNAPS): a Multicenter Randomized Trial

Обзор

The goal of this clinical trial is to compare the efficacy and the safety of a new device for cold forceps polypectomy (CFP)- a special jumbo forceps- to cold snare polypectomy (CSP) for small colorectal lesions, without adding peri- or post-procedural risks to the patient. The main questions it aims to answer are: * Does the cold forceps guarantee a complete endoscopic resection rate? * How many adverse events could the jumbo forceps reduce in comparison to CSP? * Does the lesion retrieval rate increase? * Does the polypectomy duration decrease? Participants will be randomized to one or to the other group when a polypoid or non-polypoid lesion is identified. If multiple polyps are found in the same patient, they will be removed using the same polypectomy technique. If polypectomy cannot be performed using the indicated technique, a crossover will be done according to the best practice of care principles.

Подробное описание

The study is a Multicenter, Prospective, Randomized, Controlled Study. It is designed as a non-inferiority trial to assess whether the efficacy in polypectomy of the new jumbo cold forceps is non-inferior to that of the cold snare.

The investigators hypothesize a less number of adverse events with CFP, an increased lesion retrieval rate and a less duration of the polypectomy procedure.

All patients will be contacted, 30 days post-polypectomy, by blinded medical staff assessing for possible complications.

All consecutive patients with polyp lesions can be enrolled, the participation is voluntary and randomization will be performed using the "minimization technique".

Вмешательства

• Устройство Sampling from the resection margins
  After polypectomy, the base will be irrigated and assessed by the endoscopist, who may also use virtual or vital chromoendoscopy, if needed. Any residual adenomatous tissue will be removed using the same technique. To confirm the completeness of each polypectomy, two biopsies will be taken from the resection margins for polyps ≤ 5 mm, and three biopsies for polyps 6-9 mm, using standard biopsy forces.

Первичные конечные точки

• Incomplete resection rate [Срок оценки: Immediately after the procedure and immediately after the histological evaluation of the biopsy samples]

Вторичные конечные точки (3)

• Adverse events [Срок оценки: Up to 30 days after the procedure]
• Lesion retrieval rate [Срок оценки: During the polypectomy]
• Polypectomy duration [Срок оценки: During the polypectomy]

Критерии участия

Критерии включения

• Patients aged ≥ 18 years;
• Ability to provide informed consent;
• Presence of at least one colorectal polypoid/non-polypoid lesion < 10 mm

Критерии исключения

• Primary or secondary coagulopathy;
• Improper interruption of dual antiplatelet therapy and/or antiplatelet therapy with P2Y12 receptor antagonists (clopidogrel, prasugrel, ticagrelor) and/or anticoagulant therapy;
• Chronic inflammatory bowel diseases;
• Inpatients undergoing colonoscopy;
• Colonoscopy as part of regional colorectal cancer screening;
• Pregnancy or breastfeeding

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• AUSL Modena — Carpi

Идентификаторы

NCT: NCT06970808 · 04-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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