TRIAL OF ULCER HEMORRHAGE WITH ENDOSCOPIC HEMOSTASIS

一项关于内镜止血的对照、双盲、多中心试验， 良性消化性溃疡出血将使用两种便携式设备进行。 共150例严重UGI出血住院患者， 内镜检查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）内镜止血， 双极电凝（BP），B）使用加热探头的内镜止血 (HP)或c）常规内镜治疗，无内镜止血 （对照-C）。 所有符合入选标准并告知 同意将被随机化。 分层将被制成好或坏 预后分类。 随机化将由治疗人员进行， 在内窥镜检查时，通过打开密封的信封， 表示治疗组或对照组。 另一位医生， 不知道治疗内窥镜医师给予的内窥镜治疗 将在随机化前后管理患者。 重症监护 所有患者的常规内科-外科治疗都是相似的。 在住院期间，将以标准表格收集数据， 确定患者是否受益于内镜治疗。 评价 将三组（BP、HP、C）的治疗效果进行比较 在本研究期间的四个时间点：5分钟，24小时，72小时， 七日或七日（以较早者为准）。 具体结果比较 住院期间的指标为：止血率;再出血率， 控制出血的急诊手术率;输血次数 随机化前后;住院时间（包括 重症监护室时间和常规楼层时间）;择期手术率; 并发症和死亡率。 对于死亡率以外的这些比较， 将使用分级结果评分。 将确定以下各项的比较： 所有治疗组（BP、HP、C）;活动性出血和非出血 可见血管为亚组;预后良好和不良亚组。 这项研究将由四名经验丰富的研究人员进行， 不同的研究中心，并应在5年内完成。 的 这项试验的优点是方案和研究设计;这项研究的 有效利用财政资源;完成 研究;和研究者谁都是经验丰富的治疗 接受过对照临床试验和使用 这些热凝固装置

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.