Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting

Rectal Neoplasms Clinical Trial

— GENIAL-CO  

Official title:

Resa Diagnostica Aggiuntiva Dell'Intelligenza Artificiale Nella Colonscopia (GENIAL COLONOSCOPY), Per lo Screening Del Carcinoma Colorettale

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04441580
• Other study ID #: GENIAL-CO 2.0 del 09/01/2020
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Fondazione Poliambulanza Istituto Ospedaliero
• Contact: Sebastian Manuel Milluzzo, MD
• Phone: +39 0303515373
• Email: sebastian.m.milluzzo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. The risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination. Artificial intelligence seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.

The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC).

Description:

Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. In large administrative cohort or case-control studies, the risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. The adenoma detection rate among different endoscopists has been shown to be strictly related with the risk of post-colonoscopy interval cancer. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination.Nowadays, Artificial intelligence (AI) is gaining increased attention and investigation, since it seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. GI Genius is the AI software that will be used in the present trial. The software is developed by Medtronic Inc. (Dublin, Ireland) and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.

The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC). As the risk of progression is higher for large than for small adenomas the specific contribution of the new technique in reducing the miss rate of large neoplasms represents an important outcome to be assessed in the study. In addition, given the suggested association of a higher miss-rate of serrated and flat lesions with an increased risk of early post-colonoscopy CRC, the benefit of the new technique in reducing the miss rate of these lesions will be assessed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

Inclusion Criteria:

• Patients aged 50 to 69 undergoing colonoscopy examination following a positive fecal immunochemical test (FIT) performed in the context of a regional mass-screening program.

Exclusion Criteria:

• Patients unwilling or unable to give informed consent.

• Patients reporting use of anti-platelet agents or anticoagulants precluding removal of polyps.

Related Conditions & MeSH terms

• Adenocarcinoma
• Colonic Adenocarcinoma
• Colonic Neoplasms
• Colonic Polyps
• Neoplasms
• Polyps of Colon
• Rectal Adenocarcinoma
• Rectal Neoplasms

Intervention

Device:
• CADe colonoscopy using GI Genius device
We wanted to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC) in a FIT-positive screening population.

Locations

Country	Name	City	State
Italy	Fondazione Poliambulanza Istituto Ospedaliero	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Poliambulanza Istituto Ospedaliero

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of advanced adenomas	The percentage of patients with adenomas with high-grade displasia in CADe colonoscopy group will be recorded and compared with the rate of patients with adenomas with high-grade displasia in standard colonoscopy group.	When available the histological report of polyps removed (up to 3 weeks).
Primary	Rate of patients detected with 3 or more adenomas.	The percentage of patients with 3 or more adenomas (serrated adenomas will also be considered in the calculation) in CADe colonoscopy group will be compared with the rate of patients with 3 or more adenomas (including serrated adenomas) in standard colonoscopy group.	When available the histological report of polyps removed (up to 3 weeks).
Secondary	Overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas.	The percentage of adenomas, polyps (in general), flat adenoma and serrated polyps/adenoma detected will be recorded and compared between the groups.	When available the histological report of polyps removed (up to 3 weeks).
Secondary	Size of lesions detected	The size of lesion detected will be measured in millimiters and compared between the groups.	Immediately after the procedure.
Secondary	Rate of neoplasia by colonic site	The percentage of patients with neoplasia of proximal (right colonic segments) or distal (left colonic segments and rectum) site will be assessed and compared between the groups.	Immediately after the procedure.
Secondary	Post-colonoscopy surveilance	the time interval, expressed in years, to the next suggested follow-up colonoscopy will be assessed and compared between the groups.	When available the histological report of polyps removed (up to 3 weeks).
Secondary	Time of cecal intubation.	The time to reach the cecum will be measured in minutes, recorded and compared between the groups.	Immediately after the procedure.
Secondary	Withdrawal and total procedure time.	The time of withdrawal (from cecum to anus) and of the overall colonoscopy (from anus to anus) will be measured in minutes, recorded and compared between the groups.	Immediately after the procedure.
Secondary	Learning curve.	The above-mentioned outcomes will be calculated for each endoscopist at 3, 6, 9 and 12 months.	3, 6, 9 and 12 months.
Secondary	Patient experience	Visual Analogue Scale (VAS) (0 minimum to 10 maximum) will be recorded to assess the pain before and after the colonoscopy and results will be compared between the groups.	Immediately after the procedure.
Secondary	Specific contribution of AI	Proportion of patients diagnosed with polyps which were detected only by Artificial intelligence	Immediately after the procedure.