Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding.

血流监测可预防息肉切除术后引起的溃疡出血。

• 批准号: 10417016
• 负责人: DENNIS MICHAEL JENSEN
• 金额: --
• 依托单位: VA GREATER LOS ANGELES HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-01-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10417016
• 关键词: Abdominal Pain; Academic Medical Centers; Anticoagulants; Antiplatelet Drugs; Applications Grants; Arteries; Benign; Blood Platelets; Blood flow; Caring; Cessation of life; Clinical; Clinical Trials; Clip; Colon Carcinoma; Colonic Polyps; Colonoscopy; Complication; Data; Data Files; Detection; Enrollment; Excision; Female; Guidelines; Habits; Health Care Visit; Hemorrhage; Hemostatic function; Hospitalization; Informed Consent; Intestines; Legal patent; Length of Stay; Medical; Medical center; Methods; Monitor; Natural History; Outpatients; Patients; Pharmaceutical Preparations; Physicians; Polypectomy; Polyps; Population; Practice Guidelines; Prevention; Prophylactic treatment; Publishing; Randomized; Randomized Controlled Trials; Research; Research Personnel; Resources; Risk Factors; Sample Size; Schedule; Testing; Time; Ulcer; Veterans; base; colon cancer prevention; follow-up; high risk; high risk population; hospitalization rates; prevent; prospective; public health relevance; risk stratification; screening; standard care; treatment arm; treatment group

 DESCRIPTION (provided by applicant): Severe delayed post-polypectomy induced ulcer (PPIU) bleeding is a common problem with increased numbers of colonoscopies being performed and with more patients taking anti-coagulants or anti-platelet drugs. Current medical guidelines are not effective for prevention of delayed bleeding nor is empiric closure of PPIU's with clips because the underlying artery is still patent in the ulcer base as shown by our recent Doppler endoscopic probe (DEP) studies. Specific Aims: The primary aim is to perform a randomized controlled trial (RCT) to compare rates of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for prevention of delayed bleeding in high risk patients after snare resection of benign colon polyps. Secondary specific aims are quantitate hospitalization rates and hospital days for delayed PPIU bleeding and study the natural history and risk factors. Methods: This is a RCT performed by the CURE Hemostasis Research Group for high risk patients - those with PPIU's 15 mm in size with or without drugs associated with bleeding; or patients who require anti-coagulants or anti-platelet drugs and have PPIU's 10 mm or larger. Outpatients, scheduled for screening or surveillance colonoscopies, who give written informed consent and meet entry criteria will be randomized to control/no DEP (medical treatment without PPIU closure) or DEP (as a guide to arterial blood flow detection and focal obliteration of it with hemoclips and/or low power MPEC probe). Patients will be prospectively followed at 7, 14, and 30 days for bleeding, hospitalization complications, or unscheduled visits for healthcare after polypectomies. Data will be prospectively collected, checked for completeness, de-identified, entered onto data files, and managed with SAS. Univariable and multivariable analyses will be performed to evaluate the clinical, endoscopic, and blood flow risk factors for delayed PPIU hemorrhage. Based upon recent results, our sample size estimate is for 330 patients, 165 in each treatment group. With the numbers of colonoscopies done here for screening surveillance, abdominal pain, or change in bowel habits in high risk patients and the referral of large polyps for removal, we anticipate completion of enrollment and follow-up in 4 1/2 years and the RCT in 5 years. To increase the generalizability of results to the US population and the scientific scope, we plan to enroll patients at both WLA VA medical center (primary center) and additional Veterans and many more females in a secondary center - UCLA which is a closely affiliated, university medical center where the investigators also attend.

 描述（由申请人提供）： 严重的延迟型后切除术引起的溃疡（PPIU）出血是一个普遍的问题，即进行结肠镜检查数量增加，更多的患者服用抗凝血剂或抗血域药物。当前的医疗指南对于预防延迟出血并不有效，也没有夹子的经验封闭，因为基础文物仍然是 如我们最近的多普勒内窥镜探针（DEP）研究所示，在溃疡基础中的专利。具体目的：主要目的是进行一项随机对照试验（RCT），以比较PPIU（治疗组）在Dep检测动脉血流和局灶性治疗后使用标准治疗（单独使用医疗指南）（对照）预防良性良性结肠策略后高风险患者的延迟出血患者的延迟出血率。次要的特定目的是定量住院率和医院天数，用于延迟PPIU出血并研究自然病史和危险因素。方法：这是由治疗止血研究组针对高风险患者进行的RCT - 患有PPIU的15毫米的患者的RCT，有或没有与出血有关的药物；或需要抗凝剂或抗血清药物并且具有PPIU 10毫米或更大的患者。安排筛查或监视结肠镜检查的门诊病人，给予书面知情同意书并符合入境标准，将随机分配给控制/无PPIU（如果没有PPIU封闭的医疗治疗）或DEP（作为伪影检测和使用Hemoclips和/或低功率MPEC MPEC探测器的人工制品检测和局灶性固定）。预计患者将在7、14和30天内进行出血，住院并发症或多型治疗后的医疗保健访问。预计将收集数据，检查完整性，取消识别，输入数据文件并使用SAS管理。将进行单变量和多变量分析，以评估延迟PPIU出血的临床，内窥镜和血流风险因素。根据最近的结果，我们的样本量估计值是330例患者，每个治疗组为165例。在此处进行的结肠镜检查数量用于筛查监测，腹痛或高风险患者的肠习惯的变化以及转介质息肉的转诊，我们预计在4 1/2年内完成了入学率和随访，并在5年内完成RCT。为了提高结果对美国人口和科学范围的普遍性，我们计划在WLA VA医疗中心（小学中心）和其他退伍军人和更多女性中招募患者，该中心是一个密切相关的UCLA，这是一个密切相关的大学医学中心，调查人员也参加了研究人员。