Endoluminal Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

胰管腔内注射利多卡因预防 ERCP 术后胰腺炎

• 批准号: 8098887
• 负责人: Abraham Mathew
• 金额: $ 23.03万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8098887
• 关键词: Abdominal Pain; Amylases; Anesthetics; Animal Model; Attenuated; Cholangiography; Complication; Control Groups; Development; Double-Blind Method; Dyes; Endoscopic Retrograde Cholangiopancreatography; Goals; Hour; Human; Incidence; Inflammation; Inflammatory; Lidocaine; Light; Malpractice; Medical center; Morbidity - disease rate; Normal saline; Pancreatic duct; Pancreatic enzyme; Pancreatitis; Pathway interactions; Patients; Phospholipase A2; Prevention; Procedures; Randomized; Reflex action; Risk; Safety; Serum; Sphincter of Oddi structure; Surrogate Markers; Time; acute pancreatitis; arm; control trial; interest; mortality; prevent; primary outcome; prospective; public health relevance; relating to nervous system; secondary outcome; standard of care

DESCRIPTION (provided by applicant): Acute pancreatitis is the most common serious complication of endoscopic retrograde cholangiopancreatography (ERCP) and occurs with an incidence between 5 and 15%. Approximately 55% of these occurrences are moderate to severe in magnitude, representing an enormous burden of morbidity, mortality and malpractice claims. The mechanisms of post- ERCP pancreatitis are multifactorial and involve activation of local neural arc pathways, pancreatic enzymes, and the inflammatory cascade. Lidocaine, a commonly used and inexpensive anesthetic and antiarrhythmic, has an inhibitory effect on these neural arc pathways as well as on phospholipase A2, and has been shown to attenuate or prevent acute pancreatitis in animal models. Although it has been suggested, to date there have been no studies performed using intraductal lidocaine for the specific indication of preventing post-ERCP pancreatitis in humans. We hypothesize that lidocaine, when added to the contrast material and infused into the pancreatic duct at the time of ERCP, can reduce the incidence of ERCP-induced pancreatitis by inhibiting local neural reflex arcs and phospholipase A2, both of which are activated by manipulation and inflammation of the pancreatic duct. The goal of this project is to launch a randomized, double-blind, controlled trial of patients referred to Penn State Hershey Medical Center for ERCP with a goal of 570 patients in each arm for a study power of 80%. Patients will be randomized in a 1:1 ratio to control or study group. The control arm will receive contrast dye diluted to 50% with normal saline (standard of care) and the study arm will have contrast dye diluted to 50% with lidocaine (100mg). The primary outcome will be the incidence of acute pancreatitis, defined clinically and biochemically, within 24 hours post procedure with a secondary outcome of serum amylase levels 2 hours post procedure. A safety trial of 10 patients has recently been completed without complication or incident pancreatitis. The results of this study will elucidate if lidocaine is useful in preventing pancreatitis and may shed additional light onto its mechanisms. PUBLIC HEALTH RELEVANCE: Pancreatitis is the most common serious complication of endoscopic retrograde pancreato- cholangiography (ERCP), occurring in 5-15% of patients, with 55% of these cases being considered moderate to severe in magnitude. The goal of this study is to determine if lidocaine is effective in diminishing the risk of post-ERCP pancreatitis, and to further the understanding of the safety and usefulness of lidocaine when used in ERCP.

描述(申请人提供)：急性胰腺炎是内窥镜逆行胰胆管造影术(ERCP)最常见的严重并发症，发生率在5%至15%之间。这些事件中约有55%是中等到严重的，这是发病率、死亡率和医疗事故索赔的巨大负担。ERCP术后胰腺炎的发病机制是多因素的，涉及局部神经弧通路的激活、胰酶的激活和炎症级联反应。利多卡因是一种常用的廉价麻醉剂和抗心律失常药，对这些神经弧通路和磷脂酶A2都有抑制作用，并已被证明可以减轻或预防动物模型中的急性胰腺炎。尽管有人建议，到目前为止，还没有关于使用导管内利多卡因预防人类ERCP后胰腺炎的具体适应症的研究。我们推测，当在ERCP时加入造影剂并注入胰管时，利多卡因可以通过抑制局部神经反射弧和磷脂酶A2来减少ERCP诱导的胰腺炎的发生率，这两种酶都是由操作和胰管炎症激活的。该项目的目标是启动一项随机、双盲、对照试验，将转诊至宾夕法尼亚州立好时医疗中心进行ERCP的患者进行研究，目标是每组570名患者，研究功率为80%。患者将以1：1的比例随机分为对照组或研究组。对照组将接受用生理盐水稀释到50%的对比剂(标准护理)，研究组将接受用利多卡因(100 Mg)稀释到50%的对比剂。主要结果是术后24小时内临床和生化指标确定的急性胰腺炎的发生率，次要结果是术后2小时的血清淀粉酶水平。最近完成了一项对10名患者的安全性试验，没有出现并发症或胰腺炎。这项研究的结果将阐明利多卡因在预防胰腺炎方面是否有效，并可能进一步阐明其机制。 公共卫生相关性：胰腺炎是内窥镜逆行胰胆管造影术(ERCP)最常见的严重并发症，发生在5%-15%的患者中，其中55%的患者被认为是中到重度。本研究的目的是确定利多卡因在降低ERCP术后胰腺炎风险方面是否有效，并进一步了解利多卡因在ERCP中使用的安全性和有效性。