Clinical trial NCT04032912: The Non-Optical Resect and Discard Study (NORD)
Official title: Eliminating the Need for Conventional Histopathological Assessment of Diminutive Colon Polyps - The Non-Optical Resect and Discard Study (NORD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyp of Colon
Keywords: Polyp resection
Colorectal cancer
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 1200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Examine concordance with the pathology-based surveillance recommendation of two new resect and discard models
timeFrame: 24 months
Secondary outcomes:
measure: 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
timeFrame: 24 months
measure: Re-evaluate classical optical biopsy criteria (NICE and SANO classifications)
timeFrame: 24 months
measure: Assess which factors are associated with accuracy and negative predictive value (NPV) of optical polyp diagnosis
timeFrame: 24 months
measure: Evaluate Polyp-Based Resect and Discard model
timeFrame: 24 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Daniel von Renteln, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.