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）： 严重的延迟性息肉切除术后溃疡（PPIU）出血是一个常见的问题，结肠镜检查的数量增加，更多的患者服用抗凝剂或抗血小板药物。目前的医疗指南对于预防迟发性出血无效，使用夹子经验性闭合PPIU也无效，因为下方动脉仍然 我们最近的多普勒内窥镜探头（DEP）研究显示，在溃疡基底中存在专利。具体目标：主要目的是进行一项随机对照试验（RCT），比较PPIU（治疗组）中动脉血流量DEP检测和局灶性治疗后延迟出血的发生率，与仅使用医疗指南的标准治疗（对照组）来预防高危患者的延迟出血良性结肠息肉圈套切除术后。次要的具体目标是量化延迟性PPIU出血的住院率和住院天数，并研究自然病史和风险因素。研究方法：这是一项由CURE止血研究小组针对高风险患者进行的RCT-PPIU尺寸15 mm，使用或不使用与出血相关的药物;或需要抗凝剂或抗血小板药物且PPIU尺寸10 mm或更大的患者。计划进行筛选或监测结肠镜检查的门诊患者，如果提供了书面知情同意书并符合入选标准，将被随机分配至对照/无DEP（未进行PPIU闭合的药物治疗）或DEP（作为动脉血流检测和使用止血夹和/或低功率MPEC探头进行局灶性闭塞的指南）组。将在息肉切除术后第7、14和30天前瞻性随访患者的出血、住院并发症或计划外医疗访视。将前瞻性收集数据，检查完整性，去识别，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，以评价迟发性PPIU出血的临床、内镜和血流风险因素。根据最近的结果，我们的样本量估计为330例患者，每个治疗组165例。随着结肠镜检查筛查监测、腹痛或高危患者排便习惯改变以及大息肉切除的转诊数量的增加，我们预计在4年半内完成招募和随访，5年内完成RCT。为了增加结果对美国人群和科学范围的普遍性，我们计划在WLA VA医学中心（主要中心）招募患者，并在二级中心- UCLA招募更多退伍军人和更多女性，UCLA是一个密切相关的大学医学中心，研究者也参加。