CLINICAL COORDINATING CENTER

Oddi括约肌功能障碍（SOD）包括一系列疾病，其中胆道和/或胰腺括约肌功能障碍导致腹痛。胆道型疼痛患者若曾行胆囊切除术，常考虑此诊断。评估Oddi括约肌功能障碍（EPISOD）的预测因素和干预措施试验是一项前瞻性、双盲、随机、假对照的多中心试验，最多有214名随机受试者，他们之前接受过胆囊切除术，并被诊断为SOD临床综合征（根据Rome III标准定义）。受试者将被选择为严重疼痛相关残疾（RAPID评分为3级或4级），无胆道或胰腺疾病的客观体征（即SOD III型）。总的目标是评估内镜下括约肌切开术作为治疗胆囊切除术后SOD III型成人患者疼痛的价值。成功的定义是在手术后9个月和12个月的RAPID测试中，疼痛相关的1级残疾（90天内几乎没有残疾）。受试者和研究小组成员将对治疗分配不知情。采用2:1随机分配，支持括约肌切开术，并根据括约肌测压结果（SOM -异常/正常）和中心分层。以下次要目标将被评估：1)评估SOM结果（异常/正常）与主要结果（成功/失败）之间的关系；2)在经压力测量证实的PSH患者亚组中，评估单独行胆道括约肌切开术与双行括约肌切开术的成功率；3)评估预先设定的临床预后因素对主要结局的影响；4)评估焦虑和抑郁评分随时间的变化及其与研究结果的关系；5)评估SOD III和内镜下括约肌切开术对SOD III患者的经济影响。此外，对于拒绝随机化的一部分符合条件的患者，将进行标准护理治疗的仔细随访研究（EPISOD2），以协助解释和评估EPISOD主要目标以及几个次要目标的可泛化性。

Sphincter of Oddi dysfunction (SOD) encompasses a spectrum of disorders in which dysfunction of the biliary and/or pancreatic sphincters result in abdominal pain. The diagnosis is often considered in patients with biliary-type pain who have previously undergone cholecystectomy. The Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (EPISOD) trial is a prospective, double-blind, randomized, sham-controlled multi-center trial with a maximum of 214 randomized subjects who have received a prior cholecystectomy and are diagnosed with the clinical syndrome of SOD (as defined by the Rome III criteria). Subjects will be selected with severe pain-related disability (Grade 3 or 4 on the RAPID instrument), with no objective signs of biliary or pancreatic disease (i.e. SOD type III). The overall goal is to assess the value of endoscopic sphincterotomy as a treatment for adult subjects categorized as SOD III suffering from pain after cholecystectomy. Success is defined as Grade 1 pain-related disability (little or no disability during a 90-day period) on the RAPID at 9 and 12 months post-procedure. Subjects and study team members will be blind to treatment assignment. A 2:1 randomization allocation in favor of sphincterotomy and stratified by results of sphincter manometry (SOM - abnormal/normal) and center will be used. The following secondary aims will be assessed: 1) evaluate the relationship between the results of SOM (abnormal/normal), and the primary outcome (success/failure); 2) in the sub group of patients with manometrically proven PSH, evaluate the success rate of subjects who receive biliary sphincterotomy alone versus subjects who receive dual sphincterotomy; 3) evaluate the effects of pre-specified clinical prognostic factors on the primary outcome; 4) evaluate anxiety and depression scores over time and their relation to study outcomes; and 5) evaluate the economic impact of SOD III and endoscopic sphincterotomy in patients with SOD III. In addition, for a subset of eligible patients who decline randomization, a careful follow-up study (EPISOD2) of standard of care treatment will be conducted to assist in the interpretation and assessment of generalizability of the EPISOD primary aim as well as several of the secondary aims.