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.

奥迪括约肌功能障碍 (SOD) 涵盖一系列因胆管和/或胰腺括约肌功能障碍导致腹痛的疾病。对于既往接受过胆囊切除术的胆道型疼痛患者，通常会考虑该诊断。奥迪括约肌功能障碍评估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，他们之前接受过胆囊切除术，并被诊断患有临床疾病。 SOD 综合征（根据罗马 III 标准定义）。将选择患有严重疼痛相关残疾（RAPID 仪器上的 3 级或 4 级）、没有胆道或胰腺疾病（即 SOD III 型）客观体征的受试者。总体目标是评估内镜下乳头括约肌切开术作为治疗胆囊切除术后疼痛的 SOD III 成人受试者的价值。成功定义为术后 9 个月和 12 个月时 RAPID 出现 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不知道治疗分配。将使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。将评估以下次要目标： 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) 在测压证明 PSH 的患者亚组中，评估单独接受胆道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局的影响； 4) 评估一段时间内的焦虑和抑郁评分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，对于拒绝随机分组的符合条件的患者子集，将进行护理标准治疗的仔细随访研究 (EPISOD2)，以协助解释和评估 EISOD 主要目标以及几个主要目标的普遍性。次要目标。