Results of Ercp in Sphincter of Oddi Dysfunction

奥迪括约肌功能障碍的 Ercp 结果

• 批准号: 10173281
• 负责人: PETER B COTTON
• 金额: $ 1.86万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-20 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10173281
• 关键词: Abdominal Pain; Ancillary Study; Biliary; Blood Chemical Analysis; Caliber; Characteristics; Chemistry; Cholecystectomy; Clinical; Clinical Trials; Cohort Studies; Common bile duct structure; Consensus; Data; Development; Diagnosis; Diagnostic; Disease; Duct (organ) structure; Endoscopic Retrograde Cholangiopancreatography; Enrollment; Etiology; Evaluation; Future; Goals; Guidelines; Incidence; Indomethacin; Information Systems; Intervention; Intuition; Laboratories; Lesion; Liver; Longitudinal cohort study; Measurement; Measures; Methodology; Methods; Modeling; Monitor; Operative Surgical Procedures; Opioid; Outcome; Pain; Pain intensity; Pancreas; Pancreatic duct; Pancreatitis; Parents; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Pattern; Perceived quality of life; Population; Probability; Procedures; Quality of life; Randomized; Recording of previous events; Recurrence; Reporting; Research Design; Risk; Rome; Severities; Smoking Status; Societies; Sphincter of Oddi Dysfunction; Sphincter of Oddi structure; Stents; Subgroup; Symptoms; Testing; Time; acute pancreatitis; base; bile duct; burden of illness; disability; emotional abuse; expectation; follow up assessment; follow-up; high risk; impression; improved; indexing; instrument; physical abuse; predicting response; predictive modeling; pressure; prevent; primary outcome; prospective; response; risk minimization; tool

Project summary The concept that sphincter of Oddi dysfunction (SOD) can cause pain and attacks of acute pancreatitis by raising bile and pancreatic duct intraductal pressure is intuitive. Each year in the U.S., thousands of patients are assigned a diagnosis of “suspected SOD.” SOD has been considered in patients with persistent or recurrent biliary pains after undergoing cholecystectomy, and also in patients with idiopathic acute pancreatitis. The concept that SOD can cause biliary pain in patients without any objective abnormalities (a.k.a., type III SOD) was strongly contested by the EPISOD study, which irrefutably demonstrated comparable outcomes between patients who underwent sphincterotomy or sham ERCP. Following the results of the EPISOD study, the most recent consensus definition for Functional biliary sphincter of Oddi disorder (Rome IV) still relies heavily on abnormal blood chemistries and post-cholecystectomy bile duct diameter. These are the only “objective criteria” used to distinguish patients who might still benefit from ERCP. A similar condition, functional pancreatic sphincter of Oddi disorder (FPSD), is considered for patients with idiopathic, recurrent acute pancreatitis. Given their high risk for post-ERCP pancreatitis, patients undergoing ERCP for suspected SOD are among the ideal candidates for the ongoing Stent vs. Indomethacin (SVI) trial (U01DK104833). We propose a stringent, longitudinal cohort study that is comprised of patients currently enrolled in or being considered for the parent study because of the high-risk indication of “suspected SOD.” Unlike SVI, which terminates follow-up 30 days after randomization and ERCP, this ancillary study will follow patients for 12 months after ERCP. At the time of index ERCP, patients will undergo a systematic baseline assessment to objectively quantify their disease burden and measure potential covariates associated with response to ERCP (including pain characteristics, prior surgical history, history of emotional and physical abuse, opiate utilization, quality of life, pain-related disability, expectation of response, among others). All patients will undergo a systematic follow-up assessment at 3, 6, 9, and 12 months after their index ERCP. Using a validated tool, Patient Global Impression of Change, the primary outcome is “improved” or “much improved” as reported by the patient 12 months after undergoing ERCP. Additional validated instruments will be measured throughout the study period, including those developed for the Patient-Reported Outcomes Measurement Information System (PROMIS) and a prior study of SOD (Recurrent Abdominal Pain Intensity and Disability (RAPID).

项目总结 Oddi括约肌功能障碍(SOD)可导致急性胰腺炎的疼痛和发作 通过提高胆管和胰管内压力是直观的。每年在美国，数以千计的患者 被诊断为“疑似超氧化物歧化酶”。曾考虑在患有持续性或慢性阻塞性肺疾病的患者中 接受胆囊切除术后的反复胆道疼痛，以及特发性急性胰腺炎患者。 超氧化物歧化酶可以在没有任何客观异常(也称为III型)的患者中引起胆道疼痛的概念 Sod)受到了episod研究的强烈质疑，该研究无可辩驳地证明了可比的结果。 在接受括约肌切开术或假ERCP的患者之间。根据episod研究的结果， Oddi功能障碍胆道括约肌的最新共识定义(罗马四世)仍然依赖于 严重的血液化学异常和胆囊切除术后的胆管直径。这是唯一的 “客观标准”用于区分仍可能受益于ERCP的患者。类似的情况，功能性的 胰腺Oddi括约肌紊乱(Fpsd)，被认为是特发性、复发性急性胰腺炎的患者。 胰腺炎。 鉴于ERCP术后胰腺炎的高风险，因疑似SOD而接受ERCP的患者如下 正在进行的支架与吲哚美辛(SVI)试验(U01DK104833)的理想候选者之一。我们提出了一个 一项严格的纵向队列研究，由目前参加或正在考虑参加 家长研究是因为“疑似超氧化物歧化酶”的高危指征。与SVI不同，SVI终止了30个后续行动 在随机和ERCP后几天，这项辅助研究将在ERCP后对患者进行为期12个月的跟踪研究。在 指标ERCP的时间，患者将接受系统的基线评估，以客观量化他们的 疾病负担和测量与ERCP反应相关的潜在协变量(包括疼痛 特征，既往手术史，情感和身体虐待史，鸦片使用情况，生活质量， 与疼痛相关的残疾、对反应的期望等)。所有患者都将接受系统的随访 分别在指标ERCP后3、6、9、12个月进行评估。使用经过验证的工具Patient Global 改变的印象，主要结果是如患者12所报告的“改善”或“大大改善” 在接受ERCP治疗几个月后。在整个研究期间将测量其他经过验证的仪器， 包括为患者报告的结果测量信息系统(PROIS)开发的那些 以及先前的SOD(再发性腹痛强度和残疾(快速))研究。