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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ulcerative Colitis
- Sponsor
- Mayo Clinic
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
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).
Detailed Description
AIMS: 1. Establish normal sonographic parameters in patients with an IPAA and normal pouch function. 2. Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.
Investigators
Darrell S. Pardi, M.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Adults (age ≥ 18 years)
- •Diagnosis of ulcerative colitis (UC)
- •Status post ileal pouch anal anastomosis IPAA (completed all stages)
Exclusion Criteria
- •Pediatric patients
- •Indeterminate colitis
- •Status post IPAA for familial adenomatous polyposis (FAP)
- •BMI \> 30 kg/m2
- •Decompensated Cirrhosis
- •Inability to provide informed consent
Outcomes
Primary Outcomes
Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis
Time Frame: through study completion, an average of 1 year
compared to gold standard of pouchoscopy with biopsies