Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.

Not Applicable

• Conditions: Lynch Syndrome
• Interventions: Other: White light standart colonoscopy; Device: Gi Genius, Medtronic

• Registration Number: NCT04909671
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

The purpose of this study is to assess if artificial intelligence aid colonoscopy colonoscopy is superior to conventional colonoscopy for the detection of adenomas during surveillance colonoscopy in patients with Lynch syndrome.

Detailed Description

To compare the performance of white-light colonoscopy (HD-WLE) versus white-light + CAD (CAD) for detection of adenomas (1:1 ratio). The CAD system will include an artificial intelligence-based medical device (GI Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display as a green box over suspected lesion. An adequate bowel preparation and minimum withdrawal time of 6 min will be required. Colonoscopies will be performed by experienced endoscopists and with high-definition scopes. Lesions will be collected, and histopathology findings used as the reference standard. The primary outcome of this trial will be the mean number of adenomas per colonoscopy (APC).

Study Timeline

• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-06-02
• Study Start: 2021-09-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-17
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 404

Inclusion Criteria

• Age ≥18 years with a proven pathogenic germline variant in one of the MMR genes (MLH1, MSH2, MSH6) or Epcam deletion who are under surveillance colonoscopy.

Exclusion Criteria

• Previous history of total colectomy,
• Concomitant inflammatory bowel disease,
• Inability or refuse to sign the informed consent,
• Previous colonoscopy < 12 months.
• Inadequate bowel preparation.
• Incomplete procedure.
• PMS2 mutation carriers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WLE arm	White light standart colonoscopy	Patients allocated to WLE arm will receive during colonoscopy withdrawal high definition white light endoscopy as standart of care.
CAD arm	Gi Genius, Medtronic	Patients allocated to CAD arm will receive during colonoscopy withdrawal high definition white light endoscopy aided with artificial intelligence device (Gi Genius, Medtronic)

Primary Outcome Measures

Name	Time	Method
Mean number of adenomas per colonoscopy	18 months	Compare mean number of adenomas in both arms calculated by dividing the total number of adenomas detected by the total number of colonoscopies in each arm

Secondary Outcome Measures

Name	Time	Method
Mean number of polyps per colonoscopy	18 months	Compare mean number of polyps in both arms calculated by dividing the total number of polyps (including serrated lesions and adenomas) detected by the total number of colonoscopies in each arm
Withdrawal time	18 months	time spent on inspection, from the cecum to endoscope extraction through the anus, excluding the time needed for therapeutic measures (including polypectomy).
False positives in CAD arm	18 months	Combination of: * Lesions detected by CAD (\>2s green box) after an adequate inspection with a high confidence optical diagnosis negative for neoplasia made by the endoscopist.; * Lesions detected by CAD (\>2s green box) after an adequate inspection resected by the endoscopist and with a clinically non-significant histology.
Polyp detection rate	18 months	proportion of individuals undergoing a complete colonoscopy who had at least one polyp detected between two arms.
Adenoma detection rate	18 months	proportion of individuals undergoing a complete colonoscopy who had at least one adenoma detected between two arms.
Mean number of non-clinically significant removed lesions	18 months	Lesions removed and with a histology of normal or inflammatory mucosa or removed diminutive recto-sigmoid polyps with a histology of hyperplastic
Subjective endoscopist measures	18 months	Questionary addresing the easiness and satisfaction of the procedure, detection of lesions and performance of artificial intelligence will be filled in by each endoscopist

Trial Locations

Locations (2)

María Pellisé. MD. PhD.; 🇪🇸 Barcelona, Spain

Oswaldo ortiz; 🇪🇸 Barcelona, Spain