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临床试验/NCT01462123
NCT01462123已完成不适用

Resect and Discard Strategy in Clinical Practice

Valduce Hospital1 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
286
试验地点
1
主要终点
The primary outcome of the study was to assess the agreement between "endoscopy-" and "histology-determined" surveillance strategies after small adenoma resection.

研究概览

简要总结

Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and pathologic data. Real-time imaging technologies, have shown promising results in discriminating adenomatous from non-adenomatous polyps.

The "resect and discard strategy" for small polyps (based on real-time assessment of the histology and on the endoscopic resection without pathological examination) has been shown to be cost-effective in simulation models. No data exist about the impact of this strategy in clinical practice.

The aim of present study was to assess whether the systematic use, in the everyday clinical practice, of the "resect and discard strategy" allows to correctly manage patients with small colonic polyps.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • consecutive adult outpatients undergoing colonoscopy for routine clinical indications

排除标准

  • surveillance interval was not necessarily directed by endoscopic findings (history of colorectal cancer, inflammatory bowel disease, hereditary polyposis syndromes, hereditary non-polyposis colorectal cancer)
  • colonoscopy was performed without NBI technology
  • at least one lesion > 10 mm or < 10 mm but with morphologic features suspect for malignancy (depressed or ulcerated lesions) was detected
  • bowel preparation was inadequate
  • caecal intubation was not accomplished
  • polyps could not be resected for concomitant anticoagulation treatment, 7) polyps were resected but not retrieved for pathology.

结局指标

主要结局

The primary outcome of the study was to assess the agreement between "endoscopy-" and "histology-determined" surveillance strategies after small adenoma resection.

次要结局

  • sensitivity of the endoscopic assessment (WL coupled with NBI) of small (<10 mm) adenomas
  • operative characteristics for the diagnosis of diminutive (< 5 mm) adenomas
  • the feasibility of non histologic evaluation, represented by the proportion of polyps in which a in-vivo diagnosis of adenoma can be made with high confidence
  • specificity of the endoscopic assessment
  • accuracy of the endoscopic assessment

研究者

发起方
Valduce Hospital
申办方类型
Other

研究点 (1)

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Resect and Discard Strategy in Clinical Practice | 临床试验