Clinical trial NCT03515343: Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps
Official title: Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colo-rectal Cancer
Polyps of Colon
Keywords: Cancer prevention
Endoscopy
Gastroenterology
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Pentax Medical
First posted: 2018-05-03
Enrollment: 411
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited at the endoscopy unit at the CHUM, before undergoing an elective colonoscopy.

Brief summary: This prospective randomized clinical trial aims to evaluate the new Optivista system compared to the iScan for his optical diagnosis and interval agreement monitoring with pathology. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan, and all polyps detected during the procedure, their size, location and morphology will be recorded according to the Paris classification after which all polyps will be resected per standard practices and sent for histopathologic evaluation. Further optical assessments will be performed for all polyps of 1-10 mm in size (WASP, NICE, SANO and SIMPLE classification) after with an analysis of comparison between optical diagnosis and pathology results will be performed.

Detailed description: The benefit of colonoscopy screening is based on the detection and removal of polyps neoplastic. However, the vast majority of found polyps do not harbor any risk of non-cancer neoplastic. The resection evaluation and histopathology of these polyps are associated with costs while the contribution to cancer prevention is limited. A new technique (Pentax Optivista) based on visual diagnosis of polyps has been introduced to reduce the costs associated with over-screening, and seems to be more efficient than the Pentax iScan technique.

This research project aims to evaluate the new Optivista system compared to the iScan for his optical biopsy performance and interval agreement monitoring with pathology.

This is a prospective clinical trial for which participants are recruited directly from the colonoscopy clinic. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan. Endoscope withdrawal will be done in iScan 1 mode for patients randomized to iSan and in Optivista OE2 mode for patients randomized to Optivista.

For all polyps detected during the procedure, their size, location and morphology will be recorded according to the Paris classification after which all polyps will be resected per standard practices and sent for histopathologic evaluation.

Polyps that are between 1-10mm in size (diminutive and small polyps), there will be further assessed according to WASP, NICE, SANO and SIMPLE classifications using white light imaging and using an image-enhancing endoscopy technology that enhances visualisation of the polyp surface and vascular patterns.

Concordance between optical diagnosis and pathology monitoring according to recommendations will be presented as proportions with a 95% CI. The features optical polyp diagnostic test for overall diminutive (1-5mm) polyps and by location in the colon (proximal, distal, colon and rectosigmoid segments) will be presented. For outcome measures secondary factors, including factors that may influence the optical diagnosis, proportional estimates with a 95% confidence interval (CI) will be presented. Concordance between strategies is examined using a marginal homogeneity test (Stuart-Maxwell test). For the comparison of proportions, a chi square test or a Fisher's exact two-sided test will be used, as appropriate.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Aged 45 to 80 years
* Indication for full colonoscopy

Exclusion Criteria:

* Known inflammatory bowel disease
* Active colitis
* Coagulopathy
* Familial polyposis syndrome
* Poor general health defined as an ASA class \> 3
* Emergency colonoscopies

Primary outcomes:
measure: Concordance of Optical diagnosis with the pathology based reference standard
timeFrame: 12 months
measure: Rate of polyps detected of both of the technologies (Optivista and iScan) for Optical diagnosis
timeFrame: 12 months
Secondary outcomes:
measure: Negative predictive value of rectosigmoid neoplastic polyps.
timeFrame: 12 months
measure: Concordance of biopsies with WASP classification
timeFrame: 12 months
measure: Concordance of biopsies and SIMPLE classification
timeFrame: 12 months
measure: Concordance of biopsies and SANO classification
timeFrame: 12 months
measure: Concordance of biopsies and NICE classification
timeFrame: 12 months
measure: Surveillance recommendation following the colonoscopy
timeFrame: 12 months
measure: Evaluate Polyp-Based Resect and Discard model
timeFrame: 12 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre Hospitalier Universitaire de Montréal, Research Center (CRCHUM)
name: Daniel von Renteln, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Djinbachian R, Marchand E, Pohl H, Aguilera-Fish A, Bouin M, Deslandres E, Weber A, Bouchard S, Panzini B, von Renteln D. Optical diagnosis of colorectal polyps: a randomized controlled trial comparing endoscopic image-enhancing modalities. Gastrointest Endosc. 2021 Mar;93(3):712-719.e1. doi: 10.1016/j.gie.2020.11.023. Epub 2020 Dec 2.