The Non-Optical Resect and Discard Study (NORD)

Polyp of Colon Clinical Trial

— NORD  

Official title:

Eliminating the Need for Conventional Histopathological Assessment of Diminutive Colon Polyps - The Non-Optical Resect and Discard Study (NORD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032912
• Other study ID #: 16.367
• Status: Completed
• Start date: May 12, 2017
• Est. completion date: May 31, 2019

Study information

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

Clinical Trial Summary

Eliminating the need for conventional histopathological assessment of diminutive colon polyps - The Non-Optical Resect and Discard (NORD) study

Description:

Implementation of this approach by community-based gastroenterologists has failed to reach the required quality benchmarks and studies evaluating optical biopsy have not shown diagnostic test performance results that meet standards set by society guidelines in order to promote its widespread clinical adoption. Optical polyp diagnosis and the current resect and discard approach are too complex for clinical adoption. Thus, clinical implementation of this valuable concept has not been achieved to date and its cost-saving potential has not been realized. In order to effectively operationalize a resect and discard strategy, one must find a different way to distinguish neoplastic from non-neoplastic polyps. There exist differences in the proportion of polyps found to be adenomatous in the left and right colon. One recent study reported that 30% of left-sided polyps and 76% of right-sided polyps were found to be adenomas on histology. Since polyps located in the proximal colon are more likely to be adenomas and polyps in the recto-sigmoid colon are more likely hyperplastic we hypothesized that a model based on polyp location might be able to replace optical biopsy and histopathology. Such an approach would be very simple to adopt by every clinician and would allow for easy adoption into clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Signed informed consent form

• Age 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

• Colonic Polyps
• Polyp of Colon
• Polyps

Intervention

Diagnostic Test:
• iScan
this instrument provides extra confidence for in vivo diagnosis through improved vessel and mucosal pattern characterization.

Locations

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

Sponsors (1)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine concordance with the pathology-based surveillance recommendation of two new resect and discard models	Our aim is to examine and to make a comparison of these models with the currently endorsed resect and discard approach that is based on optical polyp diagnosis and we will also obtain histopathology for all polyps as a reference gold-standard to which all models are compared.	24 months
Secondary	Assess for how many patients each model will theoretically reduce the need for histopathologic assessment and follow-up consultations to discuss pathology results and surveillance interval recommendations	Assess for how many patients each model will theoretically reduce the need for histopathologic assessment and follow-up consultations to discuss pathology results and surveillance interval recommendations	24 months
Secondary	Re-evaluate classical optical biopsy criteria (NICE and SANO classifications)	We will assess this in conjunction with different digital chromoendoscopy methods (NBI, iScan and Optivista) and assess concordance between these imaging methods and classification systems to differentiate neoplastic from non-neoplastic polyps.	24 months
Secondary	Assess which factors are associated with accuracy and negative predictive value (NPV) of optical polyp diagnosis	Assess which factors are associated with accuracy and negative predictive value (NPV) of optical polyp diagnosis	24 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.	24 months