Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Colonic Polyps

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

Fujinon high-definition + virtual chromoendoscopy

Olympus high-definition + virtual chromoendoscopy

Pentax high-definition + virtual chromoendoscopy

High-definition

Virtual chromoendoscopy

Standard

Raf Bisschops, MD PhD

Over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy.

High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps

Percentage of colonoscopies with detection of 1 or more adenomas. ADR is a well-established quality indicator in colonoscopy in the prevalence of adenomas detected (ADR) as recommended by American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Task Force (ACGTF) and European Society of Gastrointestinal Endoscopy (ESGE). Guidelines stipulate to use ADR as main quality indicator in colonoscopy.

Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas

Universitaire Ziekenhuizen KU Leuven

Intestinal Polyps

Pathological Conditions, Anatomical

Patient ≥18 years old, with capacity to consent, scheduled for diagnostic colonoscopy

GIG is an artificial intelligence unit that assists human colonoscopist in real-time to detect polyps during colonoscopy.

Four months collection period prior to activating GIG, then four months with GIG, and Four months afterwards without GIG

GI Genius (GIG)

Prof Bu'Hussain B Hayee, PHD FRCP

Dr Olaolu Olabintan, MBBS MRCP

Alena B Marynina

Olaolu Olabintan

Bu'Hussain B Hayee, MBBS, PhD

Prof Bu'Hussain B Hayee

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

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.

Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

The primary outcome measure will be adenoma detection rate. This will be studied across three phases: prior to use of CADe (baseline practice), while using CADe (study period) and finally after CADe (without the device in situ: "washout" phase).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps	NCT03243669	Colonic Adenoma	High-definition Virtual chromoe... Standard	18 Years -	Universitaire Ziekenhuizen KU Leuven
High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps	NCT03243669	Colonic Adenoma	High-definition Virtual chromoe... Standard	18 Years -	Universitaire Ziekenhuizen KU Leuven
High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps	NCT03243669	Colonic Adenoma	High-definition Virtual chromoe... Standard	18 Years -	Universitaire Ziekenhuizen KU Leuven
Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy	NCT05870332	Colonic Polyp Colonic Adenoma Colo-rectal Can...	GI Genius (GIG)	18 Years - 85 Years	King's College Hospital NHS Trust

Spots Global Cancer Trial Database for adenoma detection rate (adr)