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

项目概要/摘要： 背景：胰腺炎是内镜逆行胰胆管造影术最常见的并发症 胰胆管造影术（ERCP），占相当大的发病率，偶尔死亡，并增加 医疗保健支出。直到最近，预防ERCP术后胰腺炎（PEP）的唯一有效方法 一直是预防性胰腺支架置入术（PSP），这是一种昂贵，耗时， 技术上具有挑战性，并且具有潜在的危险。我们最近报道了一项大型随机 一项对照试验表明，直肠消炎痛，一种非甾体抗炎药， 高危患者ERCP后胰腺炎的发生率为10.0%，其中大多数（>80%）接受了胰腺支架。 这项随机对照试验的次要分析表明，单独接受吲哚美辛的受试者不太可能 与单独接受胰腺支架或接受吲哚美辛和支架联合治疗的患者相比， 即使在调整了受试者风险的潜在差异之后。如果吲哚美辛能够减少 PSP，主要的临床和成本效益在ERCP实践中可以实现。 目的：评估直肠给药吲哚美辛是否非劣效于直肠给药吲哚美辛联合直肠给药。 消炎痛联合预防性胰腺支架置入预防高危ERCP术后胰腺炎 例 方法：我们提出了一个比较有效的多中心非劣效性研究直肠癌 吲哚美辛单独与直肠吲哚美辛和预防性胰腺支架置入联合治疗 高危患者ERCP术后胰腺炎的预防。1430例受试者 通常接受胰腺支架预防的PEP风险升高的患者将随机分配至 单独的吲哚美辛或吲哚美辛和PSP的组合。发生PEP的患者比例 和中重度PEP进行比较。此外，我们会设立一个有质素保证的中央资料库 从研究参与者获得的生物标本，允许未来的转化研究阐明 PEP的分子和遗传机制，以及非甾体抗- 消炎药可以预防这种并发症。

Project Summary/Abstract: Background: 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.