Utility of Intestinal Ultrasound as a Diagnostic Tool for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of Intestinal Ultrasound (IUS) to Evaluate for Pouchitis Findings, Post Ileal Pouch-Anal Anastomosis-Number of Participants With Abnormal Ultrasound Findings
研究概览
简要总结
Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).
详细描述
AIMS:
- Establish normal sonographic parameters in patients with an IPAA and normal pouch function.
- Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (age ≥ 18 years)
- •Diagnosis of ulcerative colitis (UC)
- •Status post ileal pouch anal anastomosis IPAA (completed all stages)
排除标准
- •Pediatric patients
- •Indeterminate colitis
- •Status post IPAA for familial adenomatous polyposis (FAP)
- •BMI > 30 kg/m2
- •Decompensated Cirrhosis
- •Inability to provide informed consent
研究组 & 干预措施
Patients with Pouchitis
Transabdominal and trans perianal ultrasounds of the pouch will be performed by an experienced sonographer for each patient and interpreted by a board-certified radiologist specializing in IUS.
干预措施: Intestinal Ultrasound (Diagnostic Test)
结局指标
主要结局
Diagnostic Accuracy of Intestinal Ultrasound (IUS) to Evaluate for Pouchitis Findings, Post Ileal Pouch-Anal Anastomosis-Number of Participants With Abnormal Ultrasound Findings
时间窗: 2 hours per subject for ultrasound.
Radiologists were blinded to pouchoscopy with biopsy results and evaluated the intestinal ultrasound of the pouch for each patient; assessing whether normal healthy pouch or inflammation was present. Those results were then compared to gold standard of pouchoscopy with biopsies to confirm accuracy. The number (n(%)) of participants with abnormal ultrasound findings confirmed with gold standard are reported.
次要结局
未报告次要终点
研究者
Darrell S. Pardi, M.D.
Principal Investigator
Mayo Clinic