A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)

Официальное название

A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)

Обзор

Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 19 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps \<5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen. In this randomized controlled trial, the investigators want to compare the complete resection rates of small and intermediate sized colorectal polyps 10-15 mm with CSP and HSP.

Вмешательства

• Процедура Active Comparator: Hot Snare Polypectomy
  Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.
• Процедура Experimental: Cold Snare Polypectomy
  Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.

Первичные конечные точки

• Complete resection rate [Срок оценки: 6 months]

Вторичные конечные точки (5)

• En-bloc resection rate [Срок оценки: During procedure]
• Rate of immediate bleeding with necessity of haemostasis [Срок оценки: During procedure]
• Rate of impossible resection by CSP [Срок оценки: During procedure]
• Time required for resection [Срок оценки: During procedure]
• Rate of procedure-related adverse events. [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Indication for colonoscopy
• at least 1 adenomatous polyp 10-15 mm
• provided written informed consent

Критерии исключения

• American Society of Anaesthesiologists class IV or higher
• florid inflammatory bowel disease
• emergency indication for colonoscopy
• haemorrhagic diathesis
• continued dual antiplatelet therapy
• continued anticoagulant therapy

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

Диагностика

Центры проведения

Германия · 1 центр

• Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universi — München

Идентификаторы

NCT: NCT04816292 · 2021-90-S-P

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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