The Non-Optical Resect and Discard Study (NORD) (NORD)

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

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

Study Overview

• Status: Completed
• Conditions: Polyp of Colon
• Intervention / Treatment: Diagnostic test: iScan

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Centre Hospitalier Universitaire de Montréal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All 45-80 year old patients scheduled for an elective colonoscopy with the potential of a polyp removal will be considered for the study. This includes patients hospitalized that do not require an emergency colonoscopy (defined as colonoscopy in the emergency or intensive care unit or patients with active upper or lower gastrointestinal bleeding). Potential study subjects are approached to participate: 1) during an outpatient clinic; 2) at their arrival at the endoscopy clinic on the day of the colonoscopy; or 3) on the hospital ward (for patients hospitalized).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Daniel von Renteln, MD, PhD, Centre hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

General Publications

• Taghiakbari M, Pohl H, Djinbachian R, Barkun A, Marques P, Bouin M, Deslandres E, Panzini B, Bouchard S, Weber A, von Renteln D. The location-based resect and discard strategy for diminutive colorectal polyps: a prospective clinical study. Endoscopy. 2022 Apr;54(4):354-363. doi: 10.1055/a-1546-9169. Epub 2021 Aug 26.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2017
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 20, 2021
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Colorectal cancer; Polyp resection
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: 16.367

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No