Systematic Wide-Field EMR Scar Assessment and Therapy Audit
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
- 否
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
Professor Michael Bourke
Director of Gastrointestinal Endoscopy
Western Sydney Local Health District
