A Prospective Study to Evaluate the Performance of a Real-time System in the Estimation of Colorectal Polyp Size
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: EndoAIM.
- Кому может быть актуально
- Состояния в реестре: Colonic Polyps, CRC (Colorectal Cancer), Artificial Intelligence (AI). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Гонконг
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Colorectal polyp size is related to the risk of exhibiting advanced histological features. Moreover, polyps larger than 10 mm are associated with an elevated risk of metachronous advanced neoplasia and colorectal cancer (CRC). Consequently, accurate measurement of polyp size, especially at the 10 mm threshold is critical for risk stratification and surveillance intervals. Furthermore, polyp size is also important for the choice of the appropriate resection procedures. Underestimation may lead to delayed diagnosis, thereby increasing the risk of colorectal cancer, while overestimation may result in unnecessary surveillance endoscopies.
Подробное описание
Concerns regarding polyp size measurement are increasing. In daily practice, polyp size is mostly estimated based on visual size estimation by the endoscopist, which has proven to be inaccurate, with reported accuracies ranging from 54% to 65%. Furthermore, a prevalent terminal digit preference has been observed, with clustering of size measurements at 5-mm intervals. Additionally, inappropriate surveillance recommendations based on endoscopists' visual assessment have been documented for up to 35% of polyps. Some endoscopists routinely use non-calibrated instruments such as biopsy forceps or polypectomy snares to improve polyp size estimation. However, this approach has proven to be costly and time-consuming. Besides, endoscopes' fisheye lens can lead to size distortions depending on placement of an instrument in the center or periphery of the endoscope image.
AI-assisted systems, such as Virtual Scale Endoscopy (Fujifilm, Tokyo, Japan) and ENDOANGEL-CPS (Renmin Hospital of Wuhan University, Wuhan, China), have been developed to increase the accuracy of polyp size measurement. However, these systems have primarily been tested in video-based studies, which may not accurately reflect real-time conditions. Recently, a new artificial intelligence system (EndoAIM) has been developed that allows polyp size measurement during real-time endoscopy. This system can automatically estimate the diameter of polyps. Preclinical studies have shown promising performance for EndoAIM, with an overall accuracy of 0.98 in discriminating polyp size at the 10 mm threshold. However, its measurement accuracy has not been tested in real patients during real-time endoscopy.
In this research project, we aim to evaluate the measurement accuracy of EndoAIM for estimating colorectal polyp size in real patients during real-time endoscopy.
Вмешательства
- Устройство EndoAIM
EndoAIM will be used during the withdrawal process of the colonoscopy
Первичные конечные точки
- The primary endpoint is the difference in percentage for each measurement in discriminating polyp size at the 10mm threshold [Срок оценки: During the colonoscopy]
Вторичные конечные точки (4)
- The percentage of correctness of each measurement in discriminating polyp size at the 5 mm threshold [Срок оценки: During the colonoscopy]
- The percentage of correct accuracy of measurement [Срок оценки: During the colonoscopy]
- Proportion of polyps [Срок оценки: During the colonoscopy]
- Proportion of subjects [Срок оценки: During the colonoscopy]
Критерии участия
Критерии включения
Subjects are eligible if:
- They have received colonoscopy for screening, surveillance or symptom investigation;
- Aged 18 years older or above;
- Written informed consent obtained.
Критерии исключения
Subjects are excluded if they have:
- Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
- Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets)
- Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Гонконг · 1 центр
- Prince of Wales Hospital — Shatin
Идентификаторы
NCT: NCT06957015 · 2024.608