Clinical trial NCT01877525: Resect and Discard Approach to Diminutive Colonic Polyps
Official title: "Resect and Discard" Approach to Diminutive Colonic Polyps: Real World Applicability Amongst Both Academic and Community Gastroenterologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Polyps of Large Intestine
Keywords: colorectal polyps
resect and discard
endoscopic prediction
histological diagnosis
narrow band imaging
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients undergoing colonoscopy for colorectal cancer screening or routine surveillance indications were prospectively enrolled between October 2011 and October 2012. Written informed consent was obtained from all patients.

Brief summary: Resect and discard (RD) is a new paradigm for management of diminutive colorectal polyps wherein histology is determined by real-time endoscopic imaging; polyps are then resected and discarded rather than sent for histopathological review. The aims of this study were to compare the surveillance recommendations between RD and the standard of care where polyps are sent for histopathological review in a mixed setting of academic and community gastroenterologists and to evaluate the diagnostic performance of an RD program for management of diminutive polyps.

Detailed description: Introduction: Diminutive (≤5 mm) colorectal polyps are prevalent in the screening population but have low risk for harboring advanced villous or dysplastic components and for developing into colorectal cancer. "Resect and discard" (RD) is a new paradigm for management of these diminutive polyps wherein histology is determined by real-time endoscopic imaging; polyps are then resected and discarded rather than sent for histopathological review.

Aim: The aim of this study were to compare the surveillance recommendations between RD and the standard of care where polyps are sent for histopathological review in a mixed setting of academic and community gastroenterologists and to evaluate the diagnostic performance of an RD program for management of diminutive polyps.

Methods: This is a prospective, observational study conducted in a single outpatient endoscopy center over 12 months. Screening and surveillance colonoscopies were performed by four academic and two community gastroenterologists. All diminutive polyps (defined as ≤5 mm) were endoscopically imaged and histology predictions (adenoma vs. non-adenomatous polyp) were made using high-definition white light (HDWL) with/without narrow band imaging (NBI) at the discretion of the endoscopist. Diagnostic performance and accordance of recommended surveillance intervals from endoscopic imaging were compared to histopathological review of the polyps.

Eligibility criteria: Inclusion Criteria:

* Patients were included if diminutive polyps (defined as ≤5 mm) were identified at colonoscopy.

Exclusion Criteria:

* indication other than screening or surveillance
* no diminutive polyps were found
* an optical or histopathological diagnosis of the diminutive polyp could not be made
* the polyp was resected but not retrieved for histopathology
* a synchronous colorectal cancer was identified at the time of the colonoscopy
* polyposis syndrome
* inflammatory bowel disease
* colonoscopies not complete to cecum
* fair or poor bowel preparation

Primary outcomes:
measure: concordance of recommended surveillance intervals
timeFrame: 30 days
Secondary outcomes:
measure: diagnostic performance
timeFrame: 30 days
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University Center for Advanced Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Dayna Early, MD
role: PRINCIPAL_INVESTIGATOR
References: