TRIAL OF ULCER HEMORRHAGE WITH ENDOSCOPIC HEMOSTASIS

内镜止血治疗溃疡出血的试验

• 批准号: 3231661
• 负责人: DENNIS MICHAEL JENSEN
• 金额: $ 17.47万
• 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 1994-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3231661
• 关键词: clinical trials; gastrointestinal disorder chemotherapy; gastrointestinal hemorrhage; gastroscopy; health care cost /financing; hemostasis; histopathology; hospital patient care; human mortality; human subject; human therapy evaluation; longitudinal human study; peptic ulcer; relapse /recurrence

Four related research studies will evaluate patients with bleeding peptic ulcer disease (PUD). All are multicenter studies & include prospective data collection, entry onto CURE computer files & comprehensive data analysis of different treatment outcomes. Study I is a blinded, multicenter randomized controlled trial (RCT) of endoscopic hemostasis (endostasis) for bleeding PUD. Hospitalized pts with severe UGI hemorrhage & endoscopically documented PUD active bleeding (active) or non-bleeding visible vessels (VV) will be randomized to receive a) endostasis with heater probe (HP), b) endostasis with infection (INJ), or c) routine medical-surgical management (MED-SURG) without endostasis. Specific aims are to determine: 1) whether INJ stops active ulcer bleeding or prevents rebleeding from ulcers with VV during hospitalization more often than HP or MED-SURG therapy. 2) If outcomes of a bleeding episode are affected favorably or unfavorably by INJ compared to MED-SURG or HP therapy. 3) Whether there are characteristic profiles of pts who are affected most & least by INJ compared to HP or MED-SURG. Study II (LONG F/U) will prospectively evaluate the outcome of the RCT pts whenever they rebleed, every 4-6 months with clinical & laboratory examinations, & annually with endoscopies. Specific aims are to determine ulcer recurrence rates & patterns, rates of UGIB, side effects & mortality of MED, SURG, INJ or HP pts & 2) whether Surg or Med maintenance prevents recurrent PUD or rebleeding compared to no maintenance. Both new pts & those previously randomized will be followed up to five more years. Specific aims of Study III (HEALING) are 1) to evaluate the histopathology of bleeding PUD & injury patterns after HP or INJ in the ulcers that have bled & been resected & 2) to characterize the endoscopic healing patterns of bleeding PUD. The specific aim of Study IV (COST) is to prospectively evaluate and compare the direct & indirect costs of short term (RCT) & long-term management (LONG F/U) for the different treatments (MED, SURG, INJ, HP). These studies will be performed by 5 experienced CURE investigators with two study nurses, a statistician, and a data assistant. These studies will significantly expand our knowledge of the natural history of PUD hemorrhage; the role of MED, surgical, & endoscopic management; the bleeding PUD histopathology & patterns of recurrence; & the cost & economic impact of different treatments of bleeding PUD.

四项相关研究将评估出血患者 消化性溃疡(PUD)。所有研究都是多中心研究，包括 预期数据收集，录入CURE计算机文件和 不同治疗结果的综合数据分析。学习 I是一项多中心随机对照的盲法试验 PUD出血的内窥镜止血(内止血)。住院治疗 伴有严重UGI出血和内窥镜记录的PUD的患者 活动性出血(活动性)或非出血可见血管(VV)将 随机接受a)使用加热器探头(HP)止血，b) 感染性内凝血(INJ)，或c)常规内外科手术 无内凝的管理(MED-SURG)。具体目标是 确定：1)INJ是止住活动性溃疡出血还是预防 VV溃疡住院期间再出血更频繁 而不是HP或MED-SURG疗法。2)如果出血事件的结果 与MED-SURG相比，INJ的影响是有利的还是不利的 或者惠普疗法。3)PTS是否有特征档案 与惠普或MED-SURG相比，受INJ影响最大和最小的人群。 第二项研究(长尾/长尾)将前瞻性地评估 RCT患者每次再次出血时，每4-6个月临床和 实验室检查&每年进行内窥镜检查。特定的 目的是确定溃疡复发率和类型， UGIB，MED、SURG、INJ或HP PTS的副作用和死亡率&2) 外科或内科维护可防止PUD复发或 再出血与没有维持性相比。两个新的PTS&那些 之前的随机化将被追踪到五年以上。 研究III(康复)的具体目标是1)评估 HP或INJ后出血性PUD的组织病理学及损伤类型 在已经出血和切除的溃疡中&2)来描述 出血的PUD的内窥镜愈合模式。具体目标 研究IV(成本)的目的是前瞻性地评估和比较 短期(RCT)和长期管理的直接和间接成本 (Long F/U)，用于不同的治疗(MED、SURG、INJ、HP)。 这些研究将由5名有经验的治愈研究人员进行 有两名学习护士、一名统计员和一名数据助理。这些 研究将极大地扩展我们对自然界的认识 PUD出血史；MED、手术和内窥镜的作用 出血性PUD的组织病理学及分型 复发；&不同治疗方法的成本和经济影响 流血的PUD。