Clinical trial NCT05870332: Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy
Official title: Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colonic Polyp
Colonic Adenoma
Colo-rectal Cancer
Keywords: Artificial Intelligence
Computer assisted detection (CADe)
Colorectal cancer
Adenoma Detection Rate (ADR)
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Medtronic
name: National Institute for Health Research, United Kingdom
First posted: 2023-05-23
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unselected patients scheduled for diagnostic colonoscopy

Brief summary: The goal of this trial is to determine whether use of a Computer Assisted Detection (CADe) programme leads to an increase in ADR for either units or individual colonoscopists, independent of setting or expertise

Detailed description: This is a case-control study comparing adenoma detection rate (ADR) in hospitals (and individual colonoscopists), before, during and after use with an artificial intelligence unit called GI Genius™ (GIG). GIG is a Computer-assisted detection (CADe) module that assists the human colonoscopist in real-time, by detecting and marking out polyps during colonoscopy. It has been shown to be effective in expert colonoscopists, but the effect in non-expert, general, colonoscopists is not known.

The investigator wish to deploy GIG into colonoscopy through the UK using a step-wedge design. Sites will be randomly allocated a start date for GIG deployment, collecting data for four months prior to this. In this way, all sites will have the active intervention and will provide their own case-control data. (4 months collection prior to activating GIG, 4 months with GIG, 4 months afterwards without GIG)

The study will concentrate on non-expert colonoscopists, to determine whether GIG can increase ADR. Patients will undergo the same colonoscopy that they would have had in any case, with no additional trial visits or interventions. There will be no alteration to the usual care pathway from the patient's perspective.

If the investigator can prove GIG increases ADR in this way, it will provide support to roll out this technology routinely to improve the quality of colonoscopy nationwide.

Eligibility criteria: Inclusion Criteria:

* Any patient aged 18-85 scheduled for colonoscopy by current NHSE / British Society of Gastroenterology criteria

Exclusion Criteria:

* Colonoscopy being performed for polyp surveillance
* Unable to provide informed, written consent

Primary outcomes:
measure: CADe-ADR in real world practice
timeFrame: 24 months
Secondary outcomes:
measure: APC
timeFrame: 24 months
measure: Polyp characteristics
timeFrame: 24 months
measure: Procedure time
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: King's College Hospital NHS Trust
name: Prof Bu'Hussain B Hayee
role: PRINCIPAL_INVESTIGATOR
References: