Gastroenterology Unit, Valduce Hospital
Como, 22100, Italy
NCT Number: NCT04691401
The Italian screening program invites the resident population aged 50-74 for Fecal Immunochemical Test (FIT) every 2 years. Subjects who test positive are referred for colonoscopy. Maximizing adenoma detection during colonoscopy is of paramount importance in the framework of an organized screening program, in which colonoscopy represent the key examination. Initial studies consistently show that Artificial iIntelligence-based systems support the endoscopist in evaluating colonoscopy images potentially increasing the identification of colonic polyps. However, the studies on AI and polyp detection performed so far are mostly focused on technical issues, are based on still images analysis or recorded video segments and includes patients with different indications for colonoscopy. At the best of our knowledge, data on the impact on AI system in adenoma detection in a FIT-based screening program are lacking. The present prospective randomized controlled trial is aimed at evaluating whether the use of an AI system increases the ADR (per patient analysis) and/or the mean number of adenomas per colonoscopy in FIT-positive subjects undergoing screening colonoscopy. Therefore Patients fulfilling the inclusion criteria are randomized (1:1) in two arms: A) patients receive standard colonoscopy (with high definition-HD endoscopes) with white light (WL) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination; B) patients receive colonoscopy examinations (with HD endoscopes) equipped with an AI system (in both insertion and withdrawal phase); all polyps identified are removed and sent for histopathology examination. In the present study histopathology represents the reference standard.
Looking for future studies?
Notify Me50 year–74 year
All sexes
Interventional
Not applicable
Como, 22100, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A dedicated CNN-based AI system (CAD EYE, Fujifilm Co, Tokyo, Japan) has been recently developed. The Computer-aided diagnosis (CAD) CAD EYE system is a real-time computer-assisted image analysis that allows automatic polyp identification without modifications to the colonoscope or to the actual endoscopic procedure. When CAD EYE identifies a polyp, both a visual (a green blinking box surrounding the identified polyp, called the detection box) and an acoustic alarm pop up and attract the endoscopist attention. Around the endoscopic image a visual assist circle is shown and lights up in the direction where the suspicious polyp is detected.
Time frame: 10 months
Adenoma Detection Rate: rate of participants with at least on adenoma detected during colonoscopy
Time frame: 10 months
Adenoma per Colonoscopy: it is determined by dividing the total number of adenomas removed by the total number of colonoscopies performed
Time frame: 10 months
Adv-ADR: rate of participants with at least on advanced adenoma detected during colonoscopy
Time frame: 10 months
SSL-ADR: the serrated lesions with neoplastic potential (sessile serrated lesions-SSA; traditional serrated adenomas - TSA) detection rate.
Time frame: 10 months
The variation in ADR will be stratified according the initial ADR of endoscopists participating in the present study
Valduce Hospital
Other
Impact of AI (Artificial Intelligence) on Adenoma Detection During Colonoscopy in FIT+ Patients: a Prospective Randomized Controlled Trial
Acronym: AIFIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06160466
Adenoma, Colonic Adenoma
Brescia, Bs, Italy
View Trial DetailsNCT06812403
Colonic Polyps, Digestive System Diseases
Hangzhou, Zhejiang, China
View Trial DetailsNCT04889352
Colo-rectal Cancer, Colon Polyp
Winnipeg, Manitoba, Canada
View Trial DetailsNCT04015765
Colonic Diseases, Colonic Polyps
Montreal, Quebec, Canada
View Trial Details