Resect and Discard Approach to Diminutive Colonic Polyps

Benign Polyps of Large Intestine Clinical Trial

— RD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877525
• Other study ID #: 201105473
• Status: Completed
• Phase: N/A
• First received: June 11, 2013
• Last updated: June 11, 2013
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: June 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Polyps of Large Intestine
• Colonic Polyps
• Polyps

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University Center for Advanced Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concordance of recommended surveillance intervals	concordance of recommended surveillance intervals based on endoscopic optical diagnosis compared to histopathological diagnosis	30 days	No
Secondary	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	No