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: 7977508
• 负责人: Abraham Mathew
• 金额: $ 19.39万
• 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 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7977508
• 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（由申请人提供）：急性胰腺炎是内镜逆行胰胆管造影术（ERCP）最常见的严重并发症，发生率为5 - 15%。这些事件中约有55%的程度为中度至重度，代表了发病率、死亡率和医疗事故索赔的巨大负担。ERCP术后胰腺炎的机制是多因素的，涉及局部神经弧通路、胰腺酶和炎症级联反应的激活。利多卡因是一种常用且廉价的麻醉剂和抗胰腺炎药，对这些神经弧通路以及磷脂酶A2具有抑制作用，并已在动物模型中显示出减轻或预防急性胰腺炎。尽管已经提出，但迄今为止还没有研究使用导管内利多卡因预防人类ERCP术后胰腺炎的特定适应症。我们假设，利多卡因，当添加到造影剂和灌注到胰管的时候，ERCP，可以通过抑制局部神经反射弧和磷脂酶A2，这两者都被激活的操纵和炎症的胰管，降低ERCP诱导的胰腺炎的发病率。本项目的目标是对转诊至宾夕法尼亚州立好时医疗中心进行ERCP的患者进行随机、双盲、对照试验，每组目标为570例患者，研究把握度为80%。患者将以1：1的比例随机分配至对照组或研究组。对照组将接受用生理盐水稀释至50%的造影剂（标准治疗），研究组将接受用利多卡因（100 mg）稀释至50%的造影剂。主要结局将是术后24小时内急性胰腺炎（临床和生化定义）的发生率，次要结局是术后2小时血清淀粉酶水平。最近完成了10例患者的安全性试验，未发生并发症或胰腺炎事件。这项研究的结果将阐明利多卡因是否有助于预防胰腺炎，并可能进一步阐明其机制。 公共卫生关系：胰腺炎是内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%的病例被认为是中度至重度。本研究的目的是确定利多卡因是否能有效降低ERCP术后胰腺炎的风险，并进一步了解利多卡因用于ERCP的安全性和有效性。