Resect and Discard Approach to Diminutive Colonic Polyps (RD)

"Resect and Discard" Approach to Diminutive Colonic Polyps: Real World Applicability Amongst Both Academic and Community Gastroenterologists

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.

Study Overview

• Status: Completed
• Conditions: Benign Polyps of Large Intestine
• Intervention / Treatment: Procedure: Colonoscopy

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.

• Study Type: Observational
• Enrollment (Actual): 618

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University Center for Advanced Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients in one cohort; Consecutive adult patients undergoing colonoscopy for colorectal cancer screening or routine surveillance indications were prospectively enrolled between October 2011 and October 2012.	Procedure: Colonoscopy; The location, size, and morphology of all lesions detected during colonoscopy were recorded. The size of each identified polyp was visually estimated . All diminutive polyps (defined as ≤5 mm) were endoscopically imaged and histology predictions (adenoma vs. non-adenomatous polyp) were made using HDWL with/without NBI at the discretion of the endoscopist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concordance of recommended surveillance intervals	concordance of recommended surveillance intervals based on endoscopic optical diagnosis compared to histopathological diagnosis	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic performance	Diagnostic performance [accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)] of adenomatous and non-adenomatous polyps by optical diagnosis using HDWL with/without NBI Subgroup analyses were also planned to evaluate diagnostic performance by level of confidence in prediction, type of endoscopist (academic vs. community), and use of NBI.	30 days

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Dayna Early, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 11, 2013
• First Posted (ESTIMATE): June 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 13, 2013
• Last Update Submitted That Met QC Criteria: June 11, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: narrow band imaging; colorectal polyps; resect and discard; endoscopic prediction; histological diagnosis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: 201105473