Effect of an Artificial Intelligence-assisted Colonoscopy on Adenoma Miss Rate of Trainee-performed Colonoscopy: A Four-group Randomized Controlled Tandem Colonoscopy Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Adenoma miss rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 - 85 years old
- •Appointment for colonoscopy for colorectal cancer screening
排除标准
- •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
研究组 & 干预措施
Group A (Trainee --> expert)
The expert endoscopist insert to cecum in both passes. First pass: Trainee withdraw colonoscopy without AI. The polyps detected can be removed as suitable. The pathology for polyp will be sent.
Second pass: Expert withdraw colonoscopy without AI. The polyps detected (which is missed from the first pass) can be removed as suitable. The pathology for polyp will be sent.
干预措施: Group A (Trainee --> expert) (Device)
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 without AI. The polyps detected (which is missed from the first pass) can be removed as suitable. The pathology for polyp will be sent.
干预措施: Group B (Trainee +AI --> expert) (Device)
Group C (Trainee --> expert + AI)
The expert endoscopist insert to cecum in both passes. First pass: Trainee withdraw colonoscopy 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.
干预措施: Group C (Trainee --> expert + AI) (Device)
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.
干预措施: Group D (Trainee + AI --> expert + AI) (Device)
结局指标
主要结局
Adenoma miss rate
时间窗: Untill the end of procedure
Compare adenoma miss rate (AMR) in each groups including Non-AI/ Non-AI, Non-AI/ AI, AI/ Non-AI, and AI/ AI
次要结局
- Polyp miss rate(Untill the end of the procedure)
- Adenoma detection rate of colonoscopy underwent by the trainee(Untill the end of procedure of first pass which will be done by trainee)
研究者
Nonthalee Pausawasdi
Associate Professor
Mahidol University