Objective Sphincter of Oddi disorders (SOD) are contentious conditions in patients whose abdominal pain, idiopathic acute pancreatitis (iAP) might arise from pressurisation at the sphincter of Oddi. The present study aimed to measure the benefit of sphincterotomy for suspected SOD. Design Prospective cohort conducted at 14 US centres with 12 months follow-up. Patients undergoing first-time endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy for suspected SOD were eligible: pancreatobiliary-type pain with or without iAP. The primary outcome was defined as the composite of improvement by Patient Global Impression of Change (PGIC), no new or increased opioids and no repeat intervention. Missing data were addressed by hierarchal, multiple imputation scheme. Results Of 316 screened, 213 were enrolled with 190 (89.2%) of these having a dilated bile duct, abnormal labs, iAP or some combination. By imputation, an average of 122/213 (57.4% (95% CI 50.4% to 64.4%)) improved; response rate was similar for those with complete follow-up (99/161, 61.5% (54.0% to 69.0%)); of these, 118 (73.3%) improved by PGIC alone. Duct size, elevated labs and patient characteristics were not associated with response. AP occurred in 37/213 (17.4%) at a median of 6 months post ERCP and was more likely in those with a history of AP (30.9% vs 2.9%, p<0.0001). Conclusion Nearly 60% of patients undergoing ERCP for suspected SOD improve, although the contribution of a placebo response is unknown. Contrary to prevailing belief, duct size and labs are poor response predictors. AP recurrence was common and like observations from prior non-intervention cohorts, suggesting no benefit of sphincterotomy in mitigating future AP episodes. Data are available upon reasonable request.

中文翻译：

---

Oddi 疾病胆道括约肌切开术和特发性急性复发性胰腺炎：RESPOnD 纵向队列


目的 Oddi 括约肌疾病 （SOD） 是腹痛、特发性急性胰腺炎 （iAP） 可能由 Oddi 括约肌加压引起的患者的争议性疾病。本研究旨在衡量括约肌切开术对疑似 SOD 的益处。设计 在 14 个美国中心进行的前瞻性队列，随访 12 个月。因疑似 SOD 而首次接受内窥镜逆行胰胆管造影术 （ERCP） 联合括约肌切开术的患者符合条件：胰胆型疼痛伴或不伴 iAP。主要结局定义为患者总体印象变化 （PGIC） 改善、无新阿片类药物或增加阿片类药物且无重复干预的综合结果。缺失数据通过分层多重插补方案解决。结果 在筛选的 316 例中，纳入 213 例，其中 190 例 （89.2%） 患有胆管扩张、实验室异常、iAP 或某种组合。通过插补，平均 122/213 （57.4% （95% CI [50.4%， 64.4]））改善;完全随访患者的缓解率相似 （99/161， 61.5% （54.0%， 69.0%））;其中，118 例 （73.3%） 单独使用 PGIC 得到改善。导管大小、升高的实验室和患者特征与反应无关。AP 发生率为 37/213 （17.4%），中位时间为 ERCP 后 6 个月，并且在有 AP 病史的患者中发生的可能性更大 （30.9% vs 2.9%，p<0.0001）。结论 近 60% 因疑似 SOD 而接受 ERCP 的患者有所改善，尽管安慰剂反应的贡献尚不清楚。与普遍的看法相反，导管大小和实验室是反应不佳的预测因子。AP 复发很常见，与先前非干预队列的观察结果类似，表明括约肌切开术在减轻未来的 AP 发作方面没有益处。数据可根据合理要求提供。