Resect and Discard Approach to Diminutive Colonic Polyps

NCT ID: NCT01877525

Last Updated: 2013-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 618 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Benign Polyps of Large Intestine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Colonoscopy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dayna Early, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University Center for Advanced Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201105473

Identifier Type: -

Identifier Source: org_study_id