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)： 随着结肠镜检查次数的增加和更多的患者服用抗凝剂或抗血小板药物，息肉切除术后严重延迟性溃疡(PPIU)出血是一个常见的问题。目前的医学指南不能有效预防迟发性出血，也不能用夹子经验性关闭PPIU，因为潜在的动脉仍然 我们最新的多普勒内窥镜探头(DEP)研究显示，溃疡底部有专利。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检测动脉血流和局部治疗后的迟发性出血率，以及仅使用药物指南的标准治疗(对照组)，以预防高危患者良性结肠息肉圈套切除术后的迟发性出血。次要目标是量化延迟性PPIU出血的住院率和住院天数，并研究自然病史和危险因素。方法：这是由治愈止血研究小组为高危患者进行的RCT--那些PPIU大小为15 mm的患者，有或没有出血相关药物；或者需要抗凝剂或抗血小板药物的患者，PPIU‘s 10 mm或更大的患者。计划进行筛查或监视结肠镜检查的门诊患者，如果给予书面知情同意，并符合入选标准，将被随机分为对照组/非DEP组(不关闭PPIU的内科治疗)或DEP组(作为动脉血流检测和使用血液夹和/或低功率MPEC探头局部阻断动脉血流的指南)。患者将在7天、14天和30天接受前瞻性跟踪，观察是否有出血、住院并发症或息肉切除术后意外就诊。将前瞻性地收集数据、检查完整性、识别身份、输入数据文件并使用SAS进行管理。将进行单变量和多变量分析，以评估延迟性PPIU出血的临床、内窥镜和血流危险因素。根据最近的结果，我们的样本量估计为330名患者，每组165人。考虑到高危患者因监测、腹痛或改变排便习惯而接受结肠镜检查的次数，以及转介大息肉切除的次数，我们预计在4年半内完成登记和随访，在5年内完成随机对照试验。为了增加结果对美国人群的普适性和科学范围，我们计划在WLA VA医疗中心(主要中心)招募患者和更多的退伍军人和更多的女性进入辅助中心-UCLA，这是一个密切关联的大学医疗中心，研究人员也参加了该中心。