Artificial Intelligence-assisted Colonoscopy, Tandem Study

Официальное название

Effect of an Artificial Intelligence-assisted Colonoscopy on Adenoma Miss Rate of Trainee-performed Colonoscopy: A Four-group Randomized Controlled Tandem Colonoscopy Study

Обзор

The goal of this clinical trial is to evaluate effect of artifial intelligent (AI) system, Endoscopy as AI-powered Device (ENAD) on adenoma miss rate from colonoscopy underwent by trainee endoscopist. It will also evaluate effect of AI on adenoma and polyp detection rate from colonoscopy underwent by trainee endoscopist. The main questions it aims to answer are: • Does AI-system lower adenoma miss rate in colonoscopy underwent by trainee endoscopist? Researchers will do the tandem colonoscopy and devided the participant in 4 groups as follows: A. First pass: trainee; Second pass: expert B. First pass: trainee + AI; Second pass: expert C. First pass: trainee; Second pass: expert + AI D. First pass: trainee+AI; Second pass: expert+AI Participants will take bowel preparation in split dose regimen and nothing per oral for 4 hours. They will underwent colonoscopy as above, with sedation by anesthesiologist. Details on qualities of colonoscopy, polyps detection and pathology results will be recorded.

Подробное описание

Colon cancer accounts for one of the most common cancer worldwide and also cancer-related death. Colonoscopy is accepted to be an effective tool in colon cancer screening since the polypectomy of small adenoma can prevent colon cancer. Missed adenoma is one of the causes of interval cancer between routine colonoscopy screening. Nonvisualization is the cause of missed adenoma during colonoscopy. Artificial intelligence (AI)-assisted colonoscopy was superior then routine colonoscopy from parallel study and tandem study. Previous studies often used one same endoscopist in doing tandem colonoscopy which may still have bias. Only one previous study designed to use trainee endoscopist in the first pass and expert endoscopist in the second pass, some subgroups used AI-assisted. The result revealed the lower of adenoma miss rate (AMR) in AI-assisted colonoscopy in the first pass. This study designed to evaluate AMR of AI-assisted colonoscopy in trainee endoscopist compared to expert endoscopist, the trainee will do colonoscopy in the first pass (with or without AI) and the expert will do colonoscopy in the second pass (with or without AI). The present study aimed to evaluate effect of AI-assisted colonoscopy in trainee endoscopist.

Вмешательства

• Устройство Group A (Trainee --> expert)
  The expert endoscopist insert to cecum in both passes. First pass: Trainee withdraw colonoscopy (white-light mode) without AI. The polyps detected can be removed as suitable. The pathology for polyp will be sent. Second pass: Expert withdraw colonoscopy (white-light mode) without AI. The polyps detected (which is missed from the first pass) can be removed as suitable. The pathology for polyp will be sent.
• Устройство Group B (Trainee +AI --> expert)
  The expert endoscopist insert to cecum in both passes. First pass: Trainee withdraw colonoscopy with AI. The polyps detected can be removed as suitable. The pathology for polyp will be sent. Second pass: Expert withdraw colonoscopy (white-light mode) without AI. The polyps detected (which is missed from the first pass) can be removed as suitable. The pathology for polyp will be sent. Artificial intelligent (AI) assisted colonoscopy; ENdoscopy as AI-powered Device (ENAD) ENAD system (ENdoscopy a
• Устройство Group C (Trainee --> expert + AI)
  The expert endoscopist insert to cecum in both passes. First pass: Trainee withdraw colonoscopy (white-light mode) without AI. The polyps detected can be removed as suitable. The pathology for polyp will be sent. Second pass: Expert withdraw colonoscopy with AI. The polyps detected (which is missed from the first pass) can be removed as suitable. The pathology for polyp will be sent. Artificial intelligent (AI) assisted colonoscopy; ENdoscopy as AI-powered Device (ENAD) ENAD system (ENdoscopy a
• Устройство Group D (Trainee + AI --> expert + AI)
  The expert endoscopist insert to cecum in both passes. First pass: Trainee withdraw colonoscopy with AI. The polyps detected can be removed as suitable. The pathology for polyp will be sent. Second pass: Expert withdraw colonoscopy with AI. The polyps detected (which is missed from the first pass) can be removed as suitable. The pathology for polyp will be sent. Artificial intelligent (AI) assisted colonoscopy; ENdoscopy as AI-powered Device (ENAD) ENAD system (ENdoscopy as AI-powered Device, A

Первичные конечные точки

• Adenoma miss rate [Срок оценки: Untill the end of procedure]

Вторичные конечные точки (2)

• Polyp miss rate [Срок оценки: Untill the end of the procedure]
• Adenoma detection rate of colonoscopy underwent by the trainee [Срок оценки: Untill the end of procedure of first pass which will be done by trainee]

Критерии участия

Критерии включения

• Age 40 - 85 years old
• Appointment for colonoscopy for colorectal cancer screening

Критерии исключения

• Previous history of bowel obstruction or perforation
• Presence of coagulopathy (Prothrombin time >, = 3 second ULN; Platelet < 50,000)
• Previously diagnosed with inflammatory bowel disease or polyposis syndrome
• Pregnancy or lactation
• Severe comorbities or American Society of Anesthesiologist classification >, = 3
• Unable to sign informed consent

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

Тройное слепое

Основная цель

Диагностика

Центры проведения

Таиланд · 1 центр

• Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Ba — Bangkok

Идентификаторы

NCT: NCT07023471 · Si299/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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