ENDOSCOPIC TREATMENT FOR ULCER BLEEDING (USING CORI)
ENDOSCOPIC TREATMENT FOR ULCER BLEEDING (USING CORI)
批准号:
6177438
负责人:
David E Fleischer
金额:
$7.76万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-09-30 至 2001-08-31
中文摘要
在美国,尚未在多个实践环境中研究内镜治疗非出血可见血管(NBVV)溃疡的有效性。 美国胃肠内窥镜学会(ASGE)-临床结局研究倡议(科里)项目-是一个全国性的胃肠专家联盟,利用计算机化的内窥镜数据库收集内窥镜数据,以研究内窥镜检查的结局。 本初探性/可行性研究的主要目的是证明临床实践者组成的一个联合会收集对比两种内窥镜检查方法治疗溃疡伴NBVV的耐受性数据的能力。 将比较单独双极电凝(BP)与注射肾上腺素后双极电凝(BP/E)的有效性和安全性。 通过合并和测试试验数据收集,这将允许在多中心研究中扩展数据收集,该研究涉及多个地理位置的执业医生和各种实践环境。 这项研究的一个独特之处在于,它是第一项在美国多个实践场所进行的上消化道出血(UGIB)的有效性和安全性研究。 将在16个研究中心输入数据,并以电子方式传输用于分析。 通过实施本试点研究测试扩展的数据库结构,将为更大规模的研究奠定基础,在该研究中,将利用科里数据收集基础设施研究临床、安全性和经济结局。
英文摘要
The effectiveness of endoscopic therapy for ulcers with non-bleeding visible vessels (NBVV) has not been studied in multiple practice settings throughout the United States. The American Society for Gastrointestinal Endoscopy (ASGE) - Clinical Outcomes Research Initiative (CORI) Project - is a national consortium of gastrointestinal specialists that collects endoscopic data utilizing a computerized endoscopic database to study outcomes in endoscopy. THE PRIMARY AIM OF THIS PILOT/FEASIBILITY STUDY IS TO DEMONSTRATE THE ABILITY OF A NATIONAL CONSORTIUM OF CLINICAL PRACTITIONERS TO COLLECT EFFECTIVENESS DATA COMPARING TWO ENDOSCOPIC TREATMENTS FOR ULCERS WITH NBVV. The efficacy and safety of bipolar coagulation (BP) alone will be compared to bipolar coagulation after injection with epinephrine (BP/E). By incorporating and testing trial data collection this will permit the expansion of data collection in a multicenter study involving practicing physicians in multiple geographic sites in a variety o practice settings. A unique aspect of this study is that it is the first effectiveness and safety study of upper gastrointestinal bleeding (UGIB) performed in multiple practice sites across the United States. Data will be entered at 16 sites and transmitted electronically for analysis. By testing the expanded database structure by implementing this pilot study, the groundwork will be lain for a larger study in which clinical, safety, and economic outcomes will be investigated making use of the CORI data collection infrastructure.
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