The CARMA Technique Study

Официальное название

The Cap-Assisted Resection Margin Assessment (CARMA) Technique After Polyp Resection: a Prospective Feasibility Study of a "Novel" Approach to Reduce Polyp Recurrence

Обзор

Colonoscopic removal of polyps is an important and well-established tool in the prevention of colorectal cancers. However, high polyp recurrence rates after endoscopic resection, with resultant development of interval cancers, remains a problem; this most commonly stems from unrecognised incomplete polyp resection. Thus, a standardised endoscopic technique is needed that will allow endoscopists to consistently achieve a clear margin of resection. The investigators believe the Cap Assisted Resection Margin Assessment (CARMA) technique will address this problem. This novel technique focuses on a standardised assessment of the resection margin after endoscopic polypectomy utilising available standard high-definition video endoscopes with imaging features including narrow band imaging (NBI) and magnification endoscopy.

Вмешательства

• Процедура CARMA technique
  Once standard polyp resection and assessment of the polypectomy site without magnification is completed, the CARMA technique will be applied. This will involve an assessment of the entire polypectomy margin using cap assisted magnification endoscopy with the ability to also use NBI (at the endoscopist's discretion) and documentation of any residual polyp noted.

Первичные конечные точки

• Rate of achieving a clear resection margin using the CARMA technique [Срок оценки: Established during index procedure]

Вторичные конечные точки (11)

• Sensitivity and specificity of the CARMA technique for residual polyp detection [Срок оценки: Established during index procedure]
• Frequency of residual polyp without CARMA assessment [Срок оценки: Established during index procedure]
• Incomplete resection rate with use of CARMA technique [Срок оценки: Established during index procedure]
• Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare [Срок оценки: Established during index procedure]
• Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare [Срок оценки: Established during index procedure]
• Residual polyp rate after CARMA technique with hot snare [Срок оценки: Established during index procedure]
• Residual polyp rate after CARMA technique with cold snare [Срок оценки: Established during index procedure]
• Time required for application of the CARMA technique with < 10mm [Срок оценки: Established during index procedure]
• Time required for application of the CARMA technique with > 10mm [Срок оценки: Established during index procedure]
• Polyp recurrence rate for < 10mm polyps [Срок оценки: Established during surveillance procedure (following national guidelines - between 6 months to 5 years)]
• Polyp recurrence rate for > 10mm polyps [Срок оценки: Established during surveillance procedure (following national guidelines - between 6 months to 5 years)]

Критерии участия

Patients with colonic polyps will be considered following below criteria

Критерии включения

\- any polypectomy (though only a maximum of two polyps from one individual participant)

Критерии исключения

• polyps less than 10mm which were resected under endoscopic view with a definite > 1mm clear margin
• scar site recurrence polyps
• polyps with endoscopic evidence of invasion
• pedunculated polyps
• pseudopolyps
• participants who will not be available for follow up endoscopy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Princess Alexandra Hospital — Woolloongabba

Идентификаторы

NCT: NCT05099432 · 75076

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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