Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps

Colo-rectal Cancer Clinical Trial

— Optivista  

Official title:

Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515343
• Other study ID #: 17.135
• Status: Completed
• Start date: March 9, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: March 2018
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colonic Polyps
• Polyps
• Polyps of Colon

Intervention

Diagnostic Test:
• Screening colonoscopy according to resect-and-discard strategy
This strategy uses image enhancing techniques and optical diagnosis instead of histopathology assessment with 2 Pentax optical imaging systems (either Optivista or iScan).

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Montréal (CHUM)	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Pentax Medical

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance of Optical diagnosis with the pathology based reference standard	The Optical diagnosis of polyps using Optivista or iScan will be compared with the pathology based reference standard.	12 months
Primary	Rate of polyps detected of both of the technologies (Optivista and iScan) for Optical diagnosis		12 months
Secondary	Negative predictive value of rectosigmoid neoplastic polyps.	Secondary outcomes and data collection include test characteristics, particularly the negative predictive value of rectosigmoid neoplastic polyps.	12 months
Secondary	Concordance of biopsies with WASP classification	Verification of concordance (yes/no) between histopathological results (biopsies) and WASP classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).	12 months
Secondary	Concordance of biopsies and SIMPLE classification	Verification of concordance (yes/no) between histopathological results (biopsies) and SIMPLE classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).	12 months
Secondary	Concordance of biopsies and SANO classification	Verification of concordance (yes/no) between histopathological results (biopsies) and SANO classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).	12 months
Secondary	Concordance of biopsies and NICE classification	Verification of concordance (yes/no) between histopathological results (biopsies) and NICE classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).	12 months
Secondary	Surveillance recommendation following the colonoscopy	The proportion of patients for whom an immediate surveillance recommendation following the colonoscopy can be directly provided for each approach and how often histopathology polyp examination would have been avoided when using each strategy will be examined.	12 months
Secondary	Evaluate Polyp-Based Resect and Discard model	Surveillance interval agreement of the PBRD strategy compared with pathology-based management according to the 2020 USMSTF guidelines.	12 months