Clinical Trial: Resect and Discard Approach to Diminutive Colonic Polyps

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: Washington University School of Medicine

Current Primary Outcome: concordance of recommended surveillance intervals [ Time Frame: 30 days ]

concordance of recommended surveillance intervals based on endoscopic optical diagnosis compared to histopathological diagnosis


Original Primary Outcome: Same as current

Current Secondary Outcome: diagnostic performance [ Time Frame: 30 days ]

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.



Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: June 11, 2013
Date Started: October 2011
Date Completion:
Last Updated: June 11, 2013
Last Verified: June 2013