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临床试验/NCT01877525
NCT01877525已完成不适用

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

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 618 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
618
试验地点
1
主要终点
concordance of recommended surveillance intervals

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients were included if diminutive polyps (defined as ≤5 mm) were identified at colonoscopy.

排除标准

  • 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

结局指标

主要结局

concordance of recommended surveillance intervals

时间窗: 30 days

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

次要结局

  • diagnostic performance(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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