Digestive System Diseases

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Pathological Conditions, Anatomical

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Single arm study to test the feasibility of a new device - the OPTIC imaging probe. All participants enrolled in the study may be imaged using optical spectral reflectance and autofluorescence imaging during their endoscopy procedure.

When a suitable area of tissue is identified by the clinician during a patient's colonoscopy (e.g., a polyp), the imaging probe is inserted into the colonoscope so that it can view the tissue. Optical spectral reflectance and autofluorescence imaging is then performed to collect white light reflected by, and fluorescent light emitted from, the tissue. This is then analysed by hardware and software components in the external analysis unit.

Optical spectral reflectance and autofluorescence imaging

Julian P Teare, MD FRCP

Small growths detected in the colon (polyps) during a colonoscopy may or may not have the potential to develop into cancer. However, since visual inspection alone cannot separate all potentially harmful polyps from harmless ones, the standard approach is to remove them all for histological lab examination, exposing patients to risk of injury and putting a significant demand on hospital resources. An accurate method of determining polyp type during endoscopy would enable the clinician to only remove potentially harmful polyps. A new endoscopic optical imaging probe (OPTIC), which analyses how light interacts with tissue, is proposed to do this. The probe is contained within a normal endoscope and uses white light and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light emitted, along with normal colour pictures of the polyp surface, are measured and recorded to quantify specific characteristics of each type. Optical measurements of polyps detected in endoscopy clinics at Imperial College Healthcare NHS Trust will be analysed to determine if the signal can be used to differentiate different polyp types.

Polyps detected during a colonoscopy may range from benign to precancerous and cancerous. While experienced endoscopists can reliably recognise cancer, the difference between small polyps that have the potential to develop into cancer (adenomas) and those that do not (hyperplastic), is often ambiguous. The standard approach is to simply remove all polyps and analyse them in the histology lab. This means that many patients with hyperplastic polyps (40% of those detected) are unnecessarily exposed to risk of injury (bowel perforation and bleeding) during removal. Furthermore the NHS faces the significant cost of diagnosing this harmless colon tissue. If clinicians were able to accurately determine polyp type during endoscopy, without removal, then hyperplastic tissue could be left alone while potentially harmful tissue is removed.

A pilot study of a new endoscopic optical imaging probe (OPTIC), which analyses how different colours of light interact with tissue, is proposed. Previous research has indicated that these properties differ in hyperplastic and adenomatous polyps. The probe is contained within a normal endoscope and uses white light and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light emitted, along with normal colour pictures of the polyp surface, are measured and recorded to quantify specific characteristics of each type.

Patients attending endoscopy clinics at Imperial College Healthcare NHS Trust will be asked to allow the use of the OPTIC probe during their colonoscopy. If the clinician detects a polyp that he/she intends to remove then this will be analysed using OPTIC before removal. The histology results from the tissue sample will be recorded and correlated to the OPTIC probe measurements. The resulting library of optical data will be used to design software to automatically categorise unknown polyps based on the OPTIC signal. The accuracy of the technique will be compared to the clinicians' visual assessments. The patients' involvement in the study ceases after the colonoscopy.

Optical Polyp Testing for In Vivo Classification

Only anonymised data will be shared. The research team may share findings from the study with non-Imperial College academic collaborators, who will further develop aspects of its imaging capabilities.

Correlation of optical signals from colonic polyps and their histologically-confirmed diagnosis. Quantification of sensitivity, specificity, negative predictive value.

Sensitivity and specificity of measured optical signals in differentiating different grades of adenoma.

Is bowel preparation quality sufficient for endoscopy to proceed? Bowel preparation for some patients may be imperfect and hamper collection of optical data. A measure of the quality and hence, reliability, of the measured data must be obtained for future reference in order to prevent erroneous readings.

An estimate of the time added to an endoscopic examination of the colon due to the need to insert and remove the OPTIC probe

Imperial College London

Herbal and Botanical

All Drugs and Chemicals

Cola

Retrospective study, single blind (patient), allowing a posteriori clinical data collection of 90 patients during their passage to the ambulatory endoscopy circuit, to consider 3 groups and thus to deduce a colonic adenoma detection rate for each arm :

* Colonoscopy Only Group
* Artificial intelligence only group (IA GI GENIUS ™ alone)
* Endoscopic Cap and Artificial Intelligence Group (endoscopy cap associated with the GI GENIUS ™ IA System)

Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies

A Pilot Study: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies During a Colonoscopy: Endoscopy Cap Associated With the Artificial Intelligence GI GENIUS ™ System, the Artificial Intelligence GI GENIUS ™ Alone and Colonoscopy Alone

number of colonoscopies with the discovery of at least 1 colonic adenoma out of the total number of colonoscopies according to the use of colonoscopy alone / artificial intelligence alone / artificial intelligence combined with the endoscopic cap.

Centre Hospitalier Universitaire de Nīmes

medical student

Rectal Neoplasms

Rectal Diseases

Patients undergoing colonoscopy with artificial intelligence.

Patients undergoing colonoscopy with standard colonscopy

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.

CADe colonoscopy using GI Genius device

Sebastian Manuel Milluzzo, MD

Paola Cesaro, MD, PhD

Paola Cesaro, MD, Phd

Cristiano Spada, MD, PhD

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).

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.

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

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

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.

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.

The percentage of adenomas, polyps (in general), flat adenoma and serrated polyps/adenoma detected will be recorded and compared between the groups.

The size of lesion detected will be measured in millimiters and compared between the groups.

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.

the time interval, expressed in years, to the next suggested follow-up colonoscopy will be assessed and compared between the groups.

The time to reach the cecum will be measured in minutes, recorded and compared between the groups.

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.

The above-mentioned outcomes will be calculated for each endoscopist at 3, 6, 9 and 12 months.

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.

Proportion of patients diagnosed with polyps which were detected only by Artificial intelligence

Fondazione Poliambulanza Istituto Ospedaliero

stent placement for colorectal cancer obstruction

stent

Bertrand L MILLAT, MD-PhD

To evaluate wether colorectal stenting carry a significant clinical advantage

Randomized controlled comparison between stents and primary surgery in obstructive left colonic obstructive carcinoma outside palliative situations.

Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study

Etude Prospective Multicentrique randomisée Comparant Deux stratégies thérapeutiques Pour Les Cancers Coliques en Occlusion : stratégie Chirurgicale Exclusive Versus stratégie thérapeutique Avec Stent Colique Initial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optical Polyp Testing for In Vivo Classification	NCT03139942	Colonic Polyp Colonic Disease... Colonic Neoplas... Colonic Adenoma Colonic Adenoca... Colonic Dysplas... Colonic Carcino... Colonic Cancer Colon Hyperplas...	Optical spectra...	18 Years -	Imperial College London
Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies	NCT05080088	Adenoma Colon Colorectal Canc... Colorectal Poly... Colonic Adenoca...		18 Years - 85 Years	Centre Hospitalier Universitaire de Nīmes
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting	NCT04441580	Colonic Neoplas... Colonic Adenoca... Polyps of Colon Rectal Neoplasm... Rectal Adenocar...	CADe colonoscop...	50 Years - 69 Years	Fondazione Poliambulanza Istituto Ospedaliero
Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study	NCT00514332	Colorectal Obst... Left Colonic Ad...	stent	18 Years -	University Hospital, Montpellier
Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over	NCT02355379	Colonic Adenoca...	LV5FU2 or capec... FOLFOX4 or XELO... Observation LV5FU2 or capec...	75 Years -	Federation Francophone de Cancerologie Digestive
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting	NCT04441580	Colonic Neoplas... Colonic Adenoca... Polyps of Colon Rectal Neoplasm... Rectal Adenocar...	CADe colonoscop...	50 Years - 69 Years	Fondazione Poliambulanza Istituto Ospedaliero

Spots Global Cancer Trial Database for colonic adenocarcinoma