TRIAL OF ULCER HEMORRHAGE WITH ENDOSCOPIC HEMOSTASIS

内镜止血治疗溃疡出血的试验

• 批准号: 3231657
• 负责人: DENNIS MICHAEL JENSEN
• 金额: $ 19.59万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 1984
• 资助国家: 美国
• 起止时间: 1984-04-01 至 1989-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3231657
• 关键词: gastrointestinal hemorrhage; gastroscopy; hemostasis; hospital length of stay; human mortality; human subject; human therapy evaluation; peptic ulcer; postoperative complications; prognosis

A controlled, double blind, multi-center trial of endoscopic hemostasis for bleeding benign peptic ulcers will be performed with two portable devices. A total of 150 hospitalized patients with severe UGI hemorrhage and endoscopically documented peptic ulcer active bleeding or non-bleeding visible vessels will be randomized to receive a) endoscopic hemostasis with bipolar electrocoagulation (BP), b) endoscopic hemostasis with heater probe (HP) or c) routine endoscopy management without endoscopic hemostasis (control-C). All patients who meet entry criteria and give informed consent will be randomized. Stratification will be made into good or bad prognosis categories. Randomization will be performed by a therapeutic endoscopist at the time of endoscopy by opening a sealed envelope that designates treatment group or control. A different physician, who is unaware of the endoscopic treatment given by the therapeutic endoscopist will manage the patient before and after the randomization. Intensive care and routine medical-surgical management will be similar for all patients. Data will be collected on standard forms during the hospitalization to determine if patients benefited from the endoscopic therapy. To evaluate the treatments, comparisons of the three groups (BP, HP, C) will be made prospectively at four times during this study: 5 mins, 24 hrs, 72 hrs, discharge or seven days (whichever is earlier). Specific outcomes compared during hospitalization will be: hemostasis rates; rebleeding rates, emergency surgery rates for control of bleeding; number of transfusions before and after randomization; hospitalization duration (including intensive care unit time and regular floor time); elective surgery rates; complications; and mortality. For these comparisons other than mortality, a graded outcome score will be used. Comparisons will be determined for all treatment groups (BP, HP, C); for active bleeders and non-bleeding visible vessels as subgroups; and for good and bad prognosis subgroups. The study will be carried out by four experienced investigators in different study centers and should be completed within 5 years. The advantages of this trial are the protocol and study design; the study's efficient use of financial resources; the likelihood of completing the study; and the investigators who are all experienced therapeutic endoscopists with training in controlled clinical trials and the use of these thermal coagulation devices.

内窥镜下止血的对照、双盲、多中心临床试验 出血的良性消化性溃疡将使用两种便携式设备进行治疗。 共有150名UGI严重出血住院患者和 经内窥镜证实的消化性溃疡活动性出血或非出血 可见血管将随机接受a)内窥镜止血 双极电凝(BP)，b)加温探头内窥镜止血 (HP)或c)常规内窥镜治疗，无需内窥镜止血 (Control-C)。所有符合入院标准并提供知情信息的患者 同意将是随机的。分层将分为好与坏 预后分类。随机化将通过一种治疗性的 内窥镜医生在内窥镜检查时通过打开密封的信封 指定治疗组或对照组。一个不同的医生，他是 不知道治疗性内窥镜医生进行的内窥镜治疗 将在随机化前后管理患者。重症监护 所有患者的常规内外科治疗都将是相似的。 数据将在住院期间以标准表格收集，以 确定患者是否从内窥镜治疗中受益。评估 比较三组(BP、HP、C)的治疗效果 在本研究期间，预期为四次：5分钟、24小时、72小时、 出院或七天(以较早者为准)。比较的具体结果 住院期间将是：止血率；再出血率， 控制出血的急诊手术率.输血次数 随机前后；住院天数(含 重症监护病房时间和常规楼层时间)；择期手术率； 并发症；和死亡率。对于除死亡率以外的这些比较， 将使用分级结果分数。将确定以下各项的比较 所有治疗组(BP、HP、C)；用于活动性出血和非出血 可见血管作为亚组；预后良好和不良亚组。 这项研究将由四名经验丰富的调查人员在 不同的学习中心，并应在5年内完成。这个 这项试验的优点是方案和研究设计；研究的 有效利用财政资源；完成 研究；以及都有治疗经验的调查人员 接受过对照临床试验培训的内窥镜医师 这些热凝设备。