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临床试验/NCT03117400
NCT03117400已完成不适用

Visible Vessels do Not Predict Clinically Significant Bleeding After EMR - a Systematic Description of the Post EMR Defect

Western Sydney Local Health District1 个研究点 分布在 1 个国家目标入组 482 人开始时间: 2013年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
482
试验地点
1
主要终点
Defect features predicting clinically significant post EMR bleeding

研究概览

简要总结

To date there are no available data on the utility of the endoscopic mucosal resection (EMR) defect in stratifying the risk of immediate or delayed adverse outcomes, particularly clinically significant post EMR bleeding (CSPEB).

The investigators aimed to analyse the data to determine if any of these EMR defect features allow us to estimate the risk of CSPEB. This will help endoscopists to identify defects with a high risk of adverse outcomes and may translate into improved patient outcomes.

详细描述

CSPEB is the most frequent serious complication after wide-field EMR of laterally spreading lesions ≥ 20mm (LSLs). There is no proven therapy for CSPEB and it remains a significant drawback of EMR. Visible vessels within the post EMR defect (PED) present themselves as logical targets for prophylactic treatment to prevent CSPEB. However, the clinical significance of these vessels is largely unknown. In the majority of studies risk factors identified for CSPEB include right colon location, lesion size and aspirin use. The investigators aimed to systematically describe and evaluate the clinical significance of the various endoscopic features of the post EMR defect PED including visible vessels.

A prospective study of LSLs ≥ 20mm referred for EMR at a single tertiary referral center will be performed.

Data collection includes patient, procedural and lesion characteristics. In all cases a systematic description of the PED is undertaken. The data of particular interest to this study includes: use of blood thinners, PED features including size, number and herniation of visible vessels, submucosal haemorrhage, fibrosis, fat and exposed muscle and the rate of CSPEB.These features were analysed for significant association with CSPEB. CSPEB was defined as any bleeding occurring after the completion of the procedure necessitating emergency department presentation, hospitalization or reintervention. CSPEB was compared to features of the PED to detect significant associations, using chi2 or Fisher's exact tests. Significant univariate variables will be taken forward for binomial logistic regression modelling.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients referred for EMR of a LSL 20mm or larger
  • Signed the informed consent

排除标准

  • Clips used during the EMR procedure to close the defect, totally or partially
  • Inadequate images to adequately assess the defect
  • Use of blood thinners which have not been ceased according to the current guidelines for EMR

结局指标

主要结局

Defect features predicting clinically significant post EMR bleeding

时间窗: day of procedure until 2 weeks after the procedure

To assess if any of the defect features can predict clinically significant post EMR bleeding

次要结局

  • Defect features predicting other adverse events(day of procedure until 2 weeks after the procedure)

研究者

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

Professor Michael Bourke

Clinical Professor

Western Sydney Local Health District

研究点 (1)

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