CLINICAL COORDINATING CENTER

临床协调中心

• 批准号: 7426153
• 负责人: PETER B COTTON
• 金额: $ 99.19万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7426153
• 关键词: Abdominal Pain; Adult; Affect; Age; Anxiety; Biliary; Body mass index; Caring; Cholecystectomy; Clinical; Condition; Data; Diagnosis; Digestive System Disorders; Disease; Double-Blind Method; Early treatment; Economics; Effectiveness; Endoscopic Retrograde Cholangiopancreatography; Endoscopic Sphincterotomy; Failure; Follow-Up Studies; Functional disorder; Gender; Goals; Health Care Costs; Hypertension; Intervention; Irritable Bowel Syndrome; Literature; Manometry; Mediator of activation protein; Medical; Mental Depression; Mental disorders; Numbers; Operative Surgical Procedures; Outcome; Outcome Measure; Outcome Study; Pain; Pancreas; Pancreatic Diseases; Patients; Pattern; Persons; Placebos; Procedures; Prognostic Factor; Psychopathology; Quality of life; Randomized; Range; Rate; Recording of previous events; Recurrence; Research Personnel; Risk; Rome; Score; Specific qualifier value; Sphincter; Sphincter of Oddi Dysfunction; Standards of Weights and Measures; Study Subject; Subgroup; Symptoms; Syndrome; Time; Treatment Failure; Treatment outcome; aged; base; blind; cost; day; depressive symptoms; disability; follow-up; instrument; member; neurochemistry; pressure; prospective; success

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.

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。这种诊断通常被认为是胆源性疼痛的患者，这些患者以前曾接受过胆囊切除术。评估Oddi括约肌功能障碍的预测器和干预措施(EPISOD)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名随机受试者参加，这些受试者之前接受过胆囊切除术，并被诊断出患有超氧化物歧化酶的临床综合征(如罗马III标准所定义)。受试者将被选为与疼痛相关的严重残疾(在快速仪器上为3级或4级)，没有胆道或胰腺疾病的客观体征(即超氧化物歧化酶III型)。总体目标是评估内窥镜括约肌切开术作为治疗胆囊癌术后疼痛的SODIII级成人受试者的价值。成功定义为术后9个月和12个月时疼痛相关的1级残疾(90天内很少或没有残疾)。受试者和研究团队成员将对治疗任务视而不见。采用赞成括约肌切开的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。以下次级目标将被评估：1)评估SOM结果(异常/正常)和主要结果(成功/失败)之间的关系；2)在经测量证实的PSH患者亚组中，评估单独接受胆管括约肌切开术的受试者与接受双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果的影响；4)评估随着时间的推移焦虑和抑郁评分及其与学习结果的关系；以及5)评估SODIII和内窥镜括约肌切开术对SODIII患者的经济影响。此外，对于拒绝随机分组的部分符合条件的患者，将进行仔细的护理治疗标准随访研究(EPISOD2)，以帮助解释和评估EPISOD主要目标和几个次要目标的概括性。