Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence

Официальное название

Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial

Обзор

We hypothesize that AI-assisted colonoscopy can reduce post-colonoscopy neoplasia incidence after 3 years, over standard colonoscopy. Moreover, this protective effect may allow surveillance intervals to be lengthened, by modifying long-term outcome of high-risk subgroup.

Подробное описание

Between April 2021 and July 2022, our group completed a parallel-group, randomized controlled trial in Hong Kong. \[ENDOAID-TRAIN study; NCT04838951\] 856 subjects undergoing colonoscopies were randomized 1:1 to receive colonoscopies with CADe (ENDO-AID, Olympus Co., Japan) or standard colonoscopies (control). Our study proved that AI-assisted colonoscopies could increase the overall ADR, especially small-to-medium size adenomas. It remains questionable whether the increased detection and removal of these non-advanced adenomas can be translated into any sustained long-term benefit. The impact of this AI-driven intensive surveillance on general population and healthcare system is also largely unknown. In this research project, we aim to assess the long-term effectiveness of AI-assisted colonoscopy on adenoma recurrence and PCCRC prevention, by conducting a real-world, prospective study with longitudinal extension from a randomized trial.

Вмешательства

• Устройство ENDO-AID CADe
  ENDO-AID CADe will be used during the withdrawal process of the colonscopy

Первичные конечные точки

• Post-colonoscopy adenomas at year 3 [Срок оценки: During the colonoscopy]

Вторичные конечные точки (7)

• Post-colonoscopy AA [Срок оценки: During the colonoscopy]
• Post-colonoscopy advanced neoplasms [Срок оценки: During the colonoscopy]
• Post-colonoscopy SSL [Срок оценки: During the colonoscopy]
• Post-colonoscopy CRC [Срок оценки: During the colonoscopy]
• Post-colonoscopy adenomas and advanced adenomas [Срок оценки: During the colonoscopy]
• Size and location of post-colonoscopy adenomas and advanced adenomas [Срок оценки: During the colonoscopy]
• High-risk and low-risk group according to USMSTF guideline [Срок оценки: During the colonoscopy]

Критерии участия

Критерии включения

Subjects are eligible if:

(i) They underwent randomization to receive colonoscopy with/without CADe in ENDOAID-TRAIN study \[NCT04838951\]; (ii) They are fit and willing to undergo surveillance colonoscopy at year 3; (iii) Written informed consent obtained.

Критерии исключения

Subjects will be excluded from the study if they have any of the followings:

(i) Incomplete colonoscopy during index procedure; (ii) Known residual colorectal neoplasia not removed (except hyperplastic polyps); (iii) Underwent unscheduled interval colonoscopy before year 3; (iv) Contraindications to surveillance colonoscopy at year 3; (v) Advanced comorbid (American Society of Anesthesiologists grade 4 or above); (vi) History of CRC, hereditary polyposis syndrome or inflammatory bowel disease; (vii) History of colectomy at any time point.

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

Гонконг · 1 центр

• Prince of Wales Hospital — Гонконг

Идентификаторы

NCT: NCT06251700 · 2023.541

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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