Results of Ercp in Sphincter of Oddi Dysfunction

项目摘要 Oddi括约肌功能障碍（sphincter of Oddi dysfunction，SOD）可引起疼痛和急性胰腺炎的发作 通过提高胆管和胰管的管内压力是直观的。每年在美国，数千名患者 被诊断为“疑似SOD”SOD被认为是持续性或 胆囊切除术后复发性胆道疼痛，以及特发性急性胰腺炎患者。 SOD可以在没有任何客观异常的患者中引起胆道疼痛的概念（a.k.a.，III型 SOD）受到EPISOD研究的强烈质疑，EPISOD研究无可辩驳地证明了可比较的结果 进行括约肌切开术和假ERCP的患者之间的差异。根据EPISOD研究的结果， 功能性胆道括约肌Oddi紊乱的最新共识定义（罗马IV）仍然依赖于 血液化学异常和胆囊切除术后胆管直径这些是唯一的 “客观标准”用于区分可能仍然受益于ERCP的患者。类似的情况，功能性的 胰腺Oddi括约肌疾病（FPSD），被认为是特发性，复发性急性 胰腺炎 考虑到ERCP术后胰腺炎的高风险， 是正在进行的支架与吲哚美辛（SVI）试验（U01DK104833）的理想候选者。我们提出了一个 严格的纵向队列研究，由目前入组或考虑入组的患者组成 因为“疑似SOD”的高风险适应症，与SVI不同，SVI终止随访30 在随机化和ERCP后30天，该辅助研究将在ERCP后随访患者12个月。在 在首次ERCP时，患者将接受系统的基线评估，以客观地量化其 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、阿片类药物使用、生活质量， 疼痛相关的残疾，反应的期望，等等）。所有患者将接受系统随访 在首次ERCP后3、6、9和12个月进行评估。使用经验证的工具，患者全局 变化印象，主要结局为患者报告的“改善”或“大幅改善”12 在接受ERCP后3个月。在整个研究期间，将测量其他经确认的仪器， 包括为患者报告结局测量信息系统（PROMIS）开发的那些 以及先前的SOD（复发性腹痛强度和残疾（RAPID））研究。

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).