Colonoscopy TRaining With or Without Artificial INtelligence Among Endoscopy Residents

Официальное название

Colonoscopy Training With or Without Artificial Intelligence Among Endoscopy Residents: a Randomized Controlled Study

Обзор

Type of study: Randomized controlled study Investigated Procedure: Artificial Intelligence Software for Polyp Detection in Colonoscopy training Trial participants: Endoscopy trainees during their training with at least one year of training ahead and no previous structured exposure to CADe Objectives: Primary: Adenoma Miss Rate (AMR) in the end of the first year of training for each group and after the crossover. Secondary: Further endoscopists-related parameters will be recorded and compared between the two arms: PDR, ADR, aADR, PMR, withdrawal time, CIR, AEs The investigators will be asked, when possible, to follow-up the patients until they have their next colonoscopy or a diagnosis of CRC to assess for interval cancer.

Вмешательства

• Диагностический тест Artificial Intelligence in colonoscopy
  Training in colonoscopy with or without CADe
• Диагностический тест Conventional colonoscopy training
  The trainees will be trained with the conventional colonoscopy for the study period

Первичные конечные точки

• Adenoma Miss Rate (AMR) at the end of the first year of training for each group and after the crossover. [Срок оценки: 3 months]

Вторичные конечные точки (4)

• Polyp Miss Rate (PMR) [Срок оценки: 3 months]
• Adenoma Detection Rate (ADR) [Срок оценки: 3 months]
• Polyp Detection Rate (PDR) [Срок оценки: 3 months]
• Adverse events rate [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Trial participants: Endoscopy trainees at any time of their training, with at least one year of training ahead without previous structured exposure to CADe during their training.

Recruited patient population: Adult patients undergoing diagnostic, screening, or surveillance colonoscopy will be included.

• Provision of signed and dated informed consent form understand the risks and benefits of the study
• Aged ≥18 years old
• Able to read and write in the provided language.
• Participants capable to provide written informed consent and comply with the trial protocol.

Критерии исключения

• Trial participants: Endoscopy trainees after their basic training, during the last year of training or with systematic exposure to CADe.

Recruited patient population:

• Patients with a known contraindication for biopsy, bowel obstruction or perforation,
• Pregnant or lactating females
• Known polyposis syndromes, or who had a history of inflammatory bowel disease (IBD), CRC, or colorectal surgery.
• Any patient whose cecum is not reached and who were highly suspected of having polyposis syndromes, IBD, intestinal tuberculosis, or CRC.
• Incomplete bowel preparation (segmental Boston Bowel Preparation Score <2, or total <6)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Греция · 1 центр

• General University Hospital of Larissa — Larissa

Идентификаторы

NCT: NCT07420309 · 31637-23/07/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗