跳至主要内容
临床试验/NCT02617992
NCT02617992已完成不适用

Systematic Wide-Field EMR Scar Assessment and Therapy Audit

Western Sydney Local Health District1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年9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
200
试验地点
1
主要终点
Presence of post-EMR recurrence

研究概览

简要总结

The development of a standardised imaging protocol to detect post endoscopic mucosal resection (EMR) recurrence or residual adenoma through the comparison of biopsies of the post EMR scar with endoscopic findings.

详细描述

Removal of colonic polyps reduces colon cancer and although most polyps found are small, removal of large polyps can now be safely and effectively removed with wide field EMR. Residual polyp tissue is found at follow up colonoscopy in approximately 15% of cases however and remains a focus of attempts to improve EMR efficacy. All patients undergoing surveillance colonoscopy after EMR at Westmead Hospital Endoscopy unit will have steps of assessment and therapy of the scar recorded. Data will be entered into the large prospective audit database and also analysed separately. Data will be stored in coded format. The individual steps and the outcome of the scar interrogation and therapy will also be assessed and analysed. It is expected that these results will help guide the optimal approach to assessment and confirm the efficacy of therapy of recurrence further aiding the endoscopic approach to large colonic 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 undergoing surveillance colonoscopy of a previously resected large sessile colonic polyp or laterally spreading tumour ≥20mm in size.
  • Age > 18 years
  • Able to give informed consent to involvement in the clinical study

排除标准

  • Unable to provide informed consent for involvement

结局指标

主要结局

Presence of post-EMR recurrence

时间窗: one year

Presence of post-EMR recurrence

次要结局

  • Histological characteristics of post-EMR scar biopsies(one year)
  • Presence of post EMR scar with clip artifact(one year)
  • Number of sites of recurrence(one year)
  • Kudo pit pattern assessment(one year)
  • NICE classification(one year)
  • Scar size(one year)
  • Location of recurrence(one year)
  • Morphology of recurrence(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Western Sydney Local Health District

研究点 (1)

Loading locations...

相似试验