AI-Assisted Real-Time Endoscopic Characterization of Diminutive Colorectal Polyps in Non-Academic Hospitals

Официальное название

Artificial Intelligence-assisted Optical Diagnosis for the Resect-and-discard Strategy in Clinical Practice in Non-academic Hospitals: a Randomized Controlled Study

Обзор

To validate the feasibility of promoting colorectal diminutive polyp "predict, resect, and discard" and "diagnose and leave" strategies for non-experts in general hospitals through CADx system.

Подробное описание

This study will: (1) develop and refine a deep learning model for optical diagnosis of diminutive colorectal polyps-predicting histologic type and the presence of advanced adenoma components-based on multicenter endoscopic videos; (2) conduct a randomized controlled study recruiting endoscopists from different regions and experience levels nationwide to evaluate, with or without access to the model's diagnostic output, the success rates of implementing the "resect and discard" and "diagnose and leave" strategies as well as identifying advanced adenoma components; and (3) carry out a prospective randomized controlled trial to assess the benefits of a real-time AI-assisted endoscopic system in facilitating endoscopists' implementation of the "resect and discard" and "diagnose and leave" strategies for diminutive colorectal polyps.

Вмешательства

• Устройство AI-Assisted Real-time Endoscopic Diagnosis System
  CADx assists endoscopists in diagnosing colorectal diminutive polyps (\<=5cm) during colonoscopy using narrow-band imaging (NBI). The system provides real-time prediction values of NICE classification for colorectal polyp. The intervention group receives AI-assisted diagnostic information displayed

Первичные конечные точки

• Agreement between optical- and histology-based post-polypectomy surveillance intervals according to United States Multi-Society Task Force (USMSTF) guidelines [Срок оценки: 14 days]
• Negative Predictive Value for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Confidence [Срок оценки: 14 days]

Вторичные конечные точки (8)

• Agreement between optical- and histology-based post-polypectomy surveillance intervals according to according to European Guidelines [Срок оценки: 14 days]
• Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Asia-Pacific Guidelines [Срок оценки: 14 days]
• Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Expert Consensus on Outpatient Management of Colorectal Polyps [Срок оценки: 14 days]
• Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Diagnostic Confidence [Срок оценки: 30 days]
• Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Diminutive Polyps under High Diagnostic Confidence [Срок оценки: 14 days]
• Diagnostic Accuracy of Endoscopists in Characterizing Colorectal Diminutive Polyps when assessed with High Diagnostic Confidence. [Срок оценки: 14 days]
• Improvement in Endoscopists' Diagnostic Confidence with AI Assistance [Срок оценки: 14 days]
• Improvement in Endoscopists' Diagnostic Accuracy in Characterizing Colorectal Diminutive Polyps with AI Assistance. [Срок оценки: 14 days]

Критерии участия

Критерии включения

• Agree to participate in this prospective randomized controlled study;
• Age ≥18 years for colonoscopy;
• At least one colorectal diminutive polyp (size <=5mm) found during examination;

Критерии исключения

• Already participating in other clinical trials, having signed informed consent and being in the follow-up period of other clinical trials;
• Already participating in drug clinical trials and being in the washout period of experimental or control drugs;
• History of drug or alcohol abuse or psychological disorders in the past five years;
• Pregnant or lactating patients;
• Known polyposis syndromes;
• Patients with gastrointestinal bleeding;
• Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
• Patients with contraindications to tissue biopsy;
• Previous history of allergic reactions to bowel cleansing agent components;
• Suffering from intestinal obstruction or perforation, toxic megacolon, heart failure (Grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, etc.;
• Patient's bowel preparation BBPS score <6 for this colonoscopy;
• Researchers consider the patient unsuitable for trial participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Китай · 2 центра

• Nantong First People's Hospital — Nantong
• Wuxi Ninth People's Hospital — Wuxi

Идентификаторы

NCT: NCT07362524 · KY2024-080-A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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