TRIAL OF ULCER HEMORRHAGE WITH ENDOSCOPIC HEMOSTASIS

内镜止血治疗溃疡出血的试验

• 批准号: 3231662
• 负责人: DENNIS MICHAEL JENSEN
• 金额: $ 18.65万
• 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/3231662
• 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 消化性溃疡病（PUD）。 所有研究均为多中心研究，包括 前瞻性数据收集，输入CURE计算机文件， 不同治疗结果的综合数据分析。 研究 I是一项盲法、多中心随机对照试验（RCT）， 内镜止血（内止血）治疗PUD出血。 住院 重度UGI出血和内镜检查证实的PUD患者 活动性出血（活动性）或非出血可见血管（VV）将 随机分配接受a）使用加热探头（HP）的内止血，B） 感染性内凝血（INJ），或c）常规内科-外科 管理（MED-SURG）无内分泌。 具体的目标是 确定：1）INJ是否停止活动性溃疡出血或预防 住院期间VV溃疡再出血更常见 HP或MED-SURG治疗。 2)如果出血事件的结局 与MED-SURG相比，INJ对患者的影响有利或不利 或HP疗法。 3)是否有患者的特征性特征 与HP或MED-SURG相比，受INJ影响最大和最小的患者。 研究II（LONG F/U）将前瞻性评价 RCT患者，每当他们再出血，每4-6个月与临床& 实验室检查和每年的内窥镜检查。 具体 目的是确定溃疡复发率和模式， UGIB、MED、SURG、INJ或HP患者的副作用和死亡率和2） 外科或内科维护是否可预防PUD复发， 再出血与未进行维护相比。 新患者和那些 之前随机分配的患者将再随访5年。 研究III（愈合）的具体目的是：1）评价 HP或INJ后PUD出血和损伤模式的组织病理学 在流血的和切除的溃疡中， 出血性PUD的内镜愈合模式。 具体目标 研究IV（COST）的目的是前瞻性地评估和比较 短期和长期管理的直接和间接成本 (LONG F/U）的不同治疗（MED、SURG、INJ、HP）。 这些研究将由5名经验丰富的CURE研究者进行 两名研究护士、一名统计学家和一名数据助理。 这些 研究将大大扩展我们对自然的认识， PUD出血史; MED、手术和内镜的作用 管理;出血PUD组织病理学和模式 复发;以及不同治疗方法的成本和经济影响 流血的PUD