Results of Ercp in Sphincter of Oddi Dysfunction

奥迪括约肌功能障碍的 Ercp 结果

• 批准号: 10473039
• 负责人: PETER B COTTON
• 金额: $ 22.54万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10473039
• 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).

项目概要 Oddi括约肌功能障碍（SOD）可引起疼痛和急性胰腺炎发作的概念 在美国，每年有数千名患者通过直观地提高胆管和胰管内压力。 被指定为“疑似 SOD”的诊断。 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（又称 III 型 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 根据EPISOD研究的结果，在接受括约肌切开术或假ERCP的患者之间进行比较。 功能性胆道括约肌 Oddi 障碍（罗马 IV）的最新共识定义仍然依赖于 严重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”用于区分仍可能从 ERCP 中受益的患者。类似的情况，功能性的。 胰腺 Oddi 括约肌疾病 (FPSD) 被考虑用于患有特发性、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 是正在进行的支架与吲哚美辛 (SVI) 试验 (U01DK104833) 的理想候选者之一。 严格的纵向队列研究，由目前入组或正在考虑参加的患者组成 与 SVI 不同，SVI 终止了随访 30 随机分组和 ERCP 后几天，这项辅助研究将在 ERCP 后对患者进行 12 个月的跟踪。 在进行 ERCP 时，患者将接受系统的基线评估，以客观地量化他们的病情 疾病负担并测量与 ERCP 反应相关的潜在协变量（包括疼痛 特征、既往手术史、精神和身体虐待史、阿片类药物使用、生活质量、 所有患者都将接受系统的随访。 使用经过验证的工具 Patient Global 在 ERCP 术后 3、6、9 和 12 个月进行评估。 变化印象，主要结果是患者报告的“改善”或“大大改善”12 接受 ERCP 后几个月，将在整个研究期间测量其他经过验证的仪器， 包括为患者报告结果测量信息系统 (PROMIS) 开发的系统 以及之前对 SOD（复发性腹痛强度和残疾（RAPID））的研究。

项目成果

Characteristics of Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Sphincter of Oddi Disorders.

接受内镜逆行胰胆管造影治疗 Oddi 括约肌疾病的患者特征。

• 发表时间: 2022-03
• 作者: Coté, Gregory A;Nitchie, Haley;Elmunzer, B Joseph;Kwon, Richard S;Willingham, Field F;Wani, Sachin;Mullady, Daniel;Chak, Amitabh;Singh, Vikesh;Slivka, Adam;Varadarajulu, Shyam;Freeman, Martin;Gaddam, Srinivas;Jamidar, Priya;Tarnasky, Paul;F
• 通讯作者: F