Artificial Intelligence-assisted Colonoscopy, Tandem Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group A (Trainee --> expert), Group B (Trainee +AI --> expert), Group C (Trainee --> expert + AI), Group D (Trainee + AI --> expert + AI).
- Who it may be relevant to
- Registry conditions: Artificial Intelligence (AI), Colonoscopy Education, Adenoma Colon Polyp. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of an Artificial Intelligence-assisted Colonoscopy on Adenoma Miss Rate of Trainee-performed Colonoscopy: A Four-group Randomized Controlled Tandem Colonoscopy Study
Overview
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.
Detailed description
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.
Interventions
- Device 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. - 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 (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 - Device 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 - 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. Artificial intelligent (AI) assisted colonoscopy; ENdoscopy as AI-powered Device (ENAD) ENAD system (ENdoscopy as AI-powered Device, A
Primary outcome measures
- Adenoma miss rate [Time frame: Untill the end of procedure]
Secondary outcome measures (2)
- Polyp miss rate [Time frame: Untill the end of the procedure]
- Adenoma detection rate of colonoscopy underwent by the trainee [Time frame: Untill the end of procedure of first pass which will be done by trainee]
Eligibility criteria
Inclusion criteria
- Age 40 - 85 years old
- Appointment for colonoscopy for colorectal cancer screening
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Diagnostic
Study locations
Thailand · 1 center
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Ba — Bangkok
Identifiers
NCT: NCT07023471 · Si299/2025