Resect and Discard Approach to Diminutive Colonic Polyps
- Conditions
- Benign Polyps of Large Intestine
- Interventions
- Procedure: Colonoscopy
- Registration Number
- NCT01877525
- Lead Sponsor
- Washington University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 618
- Patients were included if diminutive polyps (defined as ≤5 mm) were identified at colonoscopy.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All patients in one cohort Colonoscopy Consecutive adult patients undergoing colonoscopy for colorectal cancer screening or routine surveillance indications were prospectively enrolled between October 2011 and October 2012.
- Primary Outcome Measures
Name Time Method concordance of recommended surveillance intervals 30 days concordance of recommended surveillance intervals based on endoscopic optical diagnosis compared to histopathological diagnosis
- Secondary Outcome Measures
Name Time Method diagnostic performance 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.
Trial Locations
- Locations (1)
Washington University Center for Advanced Medicine
🇺🇸St. Louis, Missouri, United States