BLEEDING ESOPHAGEAL VARICES

食管静脉曲张出血

• 批准号: 2141994
• 负责人: MARSHALL J ORLOFF
• 金额: $ 34.72万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-07-15 至 1995-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2141994
• 关键词: esophageal varices; health care cost /financing; human subject; liver cirrhosis; regional medical planning

Bleeding esophageal varices (BEV) due to cirrhosis is a common and highly lethal condition that is characterized by recurrent hemorrhage and early death in the majority of patients. Many types of therapy have been used for BEV, but it is not known which one is best and none has been shown unequivocally to improve long-term survival. The objective of the proposed study is to compare two widely used therapeutic modalities, emergency portacaval shunt (EPCS) and emergency and longterm endoscopic sclerotherapy (EST), with regard to (a) mortality rate, (b) duration of life, (c) quality of life, (d) direct and indirect economic costs, and (e) treatment failure, defined precisely in terms of number of blood transfusions required because of recurrent BEV. Unselected patients ("all comers") with BEV due to cirrhosis will be randomized to either EPCS or EST. The diagnostic workup will be completed rapidly, EPCS or EST will be done within 8 hours of initial contact, and lifelong follow-up will be conducted in a special clinic. Treatment crossover (EPCS to EST, and EST to PCS) will be done only after primary treatment failure has been declared. The study will be monitored by an external Advisory Committee of senior scientists, and the data will be processed and analyzed by an external biostatistical firm with widely-recognized expertise in clinical trials. The study is unique in that it will be a community-vide endeavor in which 65 San Diego area physicians and two governmental hospitals will promptly refer patients with BEV to UCSD Medical Center for inclusion in the study. By clearly determining the most effective treatment of BEV, the results of this study should have substantial impact on the survival and quality of life of the bleeding cirrhotic population, and should provide important information on the economic costs and benefits of these two forms of therapy.

肝硬化引起的食管静脉曲张出血（BEV）是一种常见且高度严重的疾病。 致命状况，其特征是反复出血和早期 大多数患者死亡。许多类型的疗法已被用于 BEV，但不知道哪一种最好，也没有展示过 明确地提高长期生存率。拟议的目标 该研究旨在比较两种广泛使用的治疗方式：紧急治疗 门腔静脉分流术 (EPCS) 以及紧急和长期内镜硬化治疗 (EST)，关于 (a) 死亡率、(b) 生命持续时间、(c) 质量 生命的损失，(d) 直接和间接的经济成本，以及 (e) 治疗失败， 精确定义为所需的输血次数，因为 复发性 BEV。未选择的 BEV 患者（“所有参与者”）由于 肝硬化将被随机分配至 EPCS 或 EST。诊断检查 将快速完成，EPCS或EST将在8小时内完成 初步接触和终身随访将在一个特殊的环境中进行 诊所。仅进行治疗交叉（EPCS 至 EST，以及 EST 至 PCS） 宣布主要治疗失败后。该研究将是 由资深科学家组成的外部咨询委员会监督，并且 数据将由外部生物统计公司进行处理和分析 临床试验领域广泛认可的专业知识。这项研究的独特之处在于 这将是一项社区视频活动，由 65 名圣地亚哥地区医生参与 两家政府医院将立即将 BEV 患者转介至 加州大学圣地亚哥分校医学中心纳入研究。通过明确确定 BEV 最有效的治疗方法，这项研究的结果应该是 出血对生存和生活质量产生重大影响 肝硬化人群，并应提供有关肝硬化的重要信息 这两种治疗形式的经济成本和效益。