Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (EPISOD)

描述（由申请人提供）： Oddi括约肌功能障碍（SOD）包括一系列的疾病，其中胆道和/或胰腺括约肌功能障碍导致腹痛。诊断通常是考虑在病人的胆汁型疼痛谁以前做过胆囊切除术。评价Oddi括约肌功能障碍的预测因素和干预措施（EPISOD）试验是一项前瞻性、双盲、随机、假对照多中心试验，最多有214名随机受试者，这些受试者既往接受过胆囊切除术，并被诊断为SOD临床综合征（根据罗马III标准定义）。将选择患有重度疼痛相关残疾（RAPID仪器上的3级或4级）、无胆道或胰腺疾病客观体征（即SOD III型）的受试者。总体目标是评估内镜下括约肌切开术作为治疗胆囊切除术后疼痛分类为SOD III的成人受试者的价值。成功定义为术后9个月和12个月RAPID上的1级疼痛相关残疾（90天内很少或没有残疾）。受试者和研究团队成员将对治疗分配设盲。将采用有利于括约肌切开术的2：1随机分配，并根据括约肌测压结果（SOM -异常/正常）和中心进行分层。本研究的次要目的为：1）评估SOM结果与（异常/正常）和主要结局（成功/失败）; 2）在经测压证实的PSH患者亚组中，评价单独接受胆道括约肌切开术的受试者与接受双重括约肌切开术的受试者的成功率; 3）评估预先指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局的关系;评价SOD III和内镜下括约肌切开术对SOD III患者的经济影响。此外，对于拒绝随机化的合格患者子集，将进行一项标准治疗的仔细随访研究（EPISOD 2），以帮助解释和评估EPISOD主要目的以及几个次要目的的普遍性。

DESCRIPTION (provided by applicant): 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.