ACTRN12621000450819招募中3 期
TRA Pain Study - Investigating the effectiveness of Ursodeoxycholic acid on Recurrent Abdominal Pain in adults with Low Phospholipid Associated Cholelithiasis (LPAC)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1)Patients aged greater than 18 years with a previous cholecystectomy with more than 2 episodes of biliary pain in the last 12 months.
- •Characteristics of biliary pain as defined by the Rome IV criteria:
- •Pain located in the epigastrium and/or right upper quadrant and all of the following:
- •o1. Builds up to a steady level and lasting 30 minutes or longer.
- •o2. Occurring at different intervals (not daily).
- •o3. Severe enough to interrupt daily activities or lead to an emergency department visit.
- •o4. Not significantly (<20%) related to bowel movements.
- •o5. Not significantly (<20%) relieved by postural change or acid suppression.
- •Supportive Criteria
- •The pain may be associated with:
- •o1. Nausea and vomiting.
- •o2. Radiation to the back and/or right infrasubscapular region.
- •o3. Waking from sleep.
- •2)At least 2 additional features of:
- •a)Age less than 40 years at onset of biliary symptoms.
- •b)Imaging features consistent with LPAC:
- •oIntrahepatic echogenic foci in a position consistent with biliary tree, with either comet tail artefact, acoustic shadowing, or twinkle artefact. Echoes that have an appearance consistent with biliary gas will not qualify under this inclusion definition.
- •oIntrahepatic gallstones evidenced by US, CT, including CT-intravenous cholangiography, direct cholangiography, or MRCP.
- •oIntrahepatic strictures and dilatation typical of LPAC
- •c)Familial history of cholecystectomy in first-degree relatives age <40 years
- •d)Evidence of transiently abnormal liver function tests corresponding with episodes of biliary pain
排除标准
- •Stone in the common bile duct on imaging.
- •Known history of primary sclerosing cholangitis, primary biliary cholangitis, colitis, Crohn’s disease, cystic fibrosis, chronic liver disease.
- •Presence of significant psychiatric disorders:
- •oLifetime psychotic disorders, bipolar disorder;
- •oSubstance use disorders within 6 months;
- •oEating disorders within 2 years;
- •oModerate & severe depression defined BDI cutoff scores >22 (unless receiving stable psychiatric therapy for six weeks); and/or,
- •oSuicidal risk - a score of greater than 0 on question 9 of the BDI.
- •Pregnancy: Women who are pregnant or are planning a pregnancy within 2 years at the time of screening will be excluded from the study.
- •Upper endoscopy examination with significant findings to explain the pain.
- •Any functional bowel disorders.
- •Cholecystectomy less than 90 days before enrollment.
- •Any use of regular narcotics.
- •Inability to comply with study procedures and agents.
- •Any significant medical illness that would interfere with study participation.
- •Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
研究者
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