Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial

支架与吲哚美辛预防 ERCP 术后胰腺炎：SVI 试验

• 批准号: 9066676
• 负责人: Badih Joseph Elmunzer
• 金额: $ 181.5万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-15 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9066676
• 关键词: Accounting; Anti-Inflammatory Agents; Anti-inflammatory; Biological; Clinical; Complication; Costs and Benefits; Data; Diagnostic; Endoscopic Retrograde Cholangiopancreatography; Feces; Future; Grant; Health; Health Care Costs; Health Expenditures; Indomethacin; Inflammation; Intervention; Liquid substance; Methods; Molecular Genetics; Morbidity - disease rate; Multi-Institutional Clinical Trial; Outcome; Pancreas; Pancreatitis; Participant; Patients; Pharmaceutical Preparations; Plasma; Prevention; Procedures; Prophylactic treatment; Randomized; Randomized Controlled Trials; Reporting; Risk; Secondary to; Serum; Severities; Specimen; Stents; Study Subject; Therapeutic; Time; Translational Research; Urine; Whole Blood; comparative effectiveness; cost; high risk; improved; mortality; prevent; prophylactic; rectal; repository

 DESCRIPTION (provided by applicant): Pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality, and increased health care expenditures. Until recently, the only effective method of preventing post-ERCP pancreatitis (PEP) had been prophylactic pancreatic stent placement (PSP), an intervention that is costly, time consuming, technically challenging, and potentially dangerous. We recently reported the results of a large randomized controlled trial demonstrating that rectal indomethacin, a non-steroidal anti-inflammatory drug, reduced the risk of pancreatitis after ERCP in high-risk patients, most of whom (>80%) had received a pancreatic stent. Secondary analysis of this RCT suggested that subjects who received indomethacin alone were less likely to develop PEP than those who received a pancreatic stent alone or the combination of indomethacin and stent, even after adjusting for underlying differences in subject risk. If indomethacin were to obviate the need for PSP, major clinical and cost benefits in ERCP practice could be realized. Objective: To assess whether rectal indomethacin alone is non-inferior to the combination of rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP pancreatitis in high-risk cases. Methods: We are proposing a comparative effectiveness multi-center non-inferiority study of rectal indomethacin alone vs. the combination of rectal indomethacin and prophylactic pancreatic stent placement for the prevention of post-ERCP pancreatitis in high-risk patients. One thousand four hundred and thirty subjects at elevated risk for PEP who would normally receive a pancreatic stent for prophylaxis will be randomized to indomethacin alone or the combination of indomethacin and PSP. The proportion of patients developing PEP and moderate-severe PEP will be compared. In addition, we will establish a quality-assured central repository of biological specimens obtained from study participants, permitting future translational research elucidating the molecular and genetic mechanisms of PEP, as well as the mechanisms by which non-steroidal anti-inflammatory drugs prevent this complication.

 描述（由申请人提供）：胰腺炎是内镜逆行胰胆管造影术（ERCP）最常见的并发症，导致大量发病率、偶尔死亡率和医疗保健费用增加。直到最近，预防ERCP术后胰腺炎（PEP）的唯一有效方法是预防性胰腺支架置入（PSP），这是一种昂贵、耗时、技术上具有挑战性和潜在危险的干预措施。我们最近报道了一项大型随机对照试验的结果，该试验表明直肠给药吲哚美辛（一种非甾体抗炎药）可降低高危患者ERCP后胰腺炎的风险，其中大多数（>80%）患者接受了胰腺支架。这项随机对照试验的二次分析表明，单独接受吲哚美辛的受试者发生PEP的可能性低于单独接受胰腺支架或吲哚美辛和支架联合治疗的受试者，即使在调整了受试者风险的潜在差异后。如果吲哚美辛能够消除PSP的需要，则ERCP实践中的主要临床和成本效益可以实现。目标：评估在预防高危病例ERCP术后胰腺炎方面，单独使用直肠吲哚美辛是否非劣效于直肠吲哚美辛联合预防性胰腺支架置入。研究方法：我们提出了一项比较有效性的多中心非劣效性研究，比较单独使用直肠吲哚美辛与直肠吲哚美辛联合预防性胰腺支架置入术预防高危患者ERCP术后胰腺炎的效果。将1430例PEP风险升高的受试者随机分配至吲哚美辛单药治疗组或吲哚美辛与PSP联合治疗组，这些受试者通常接受胰腺支架预防。将比较发生PEP和中重度PEP的患者比例。此外，我们将建立一个质量有保证的中央储存库的生物标本从研究参与者，允许未来的翻译研究阐明PEP的分子和遗传机制，以及非甾体抗炎药预防这种并发症的机制。