Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology

Официальное название

Saving by Artificial Intelligence for Virtual Endoscopy Biopsy Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology

Обзор

This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. A cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. To improve personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.

Вмешательства

• Устройство Standard, high-definition colonoscopy with the use of CADe assistance
  All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
• Устройство Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ
  All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
• Устройство Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ
  Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.

Первичные конечные точки

• Non-inferiority in Adenoma Detection Rate [Срок оценки: 4 years]

Вторичные конечные точки (3)

• Negative Predictive Value for colorectal neoplasia [Срок оценки: 4 years]
• Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy [Срок оценки: 4 years]
• Change in the cost of polypectomy and histology in screening programs [Срок оценки: 4 years]

Критерии участия

Критерии включения

• All >40 years-old patients undergoing colonoscopy for selected indications

Критерии исключения

• patients with personal history of CRC, or IBD
• patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
• patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale <2 in any colonic segment).
• patients with previous colonic resection.
• patients on antithrombotic therapy, precluding polyp resection.
• patients who were not able or refused to give informed written consent.

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

Профилактика

Центры проведения

Италия · 2 центра

• Istituto Clinico Humanitas — Rozzano
• Istituto Clinico Humanitas — Rozzano

Идентификаторы

NCT: NCT06041945 · 3483 - SAVE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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