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NCT06316999 Clinical Trial

Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis

Ulcerative Colitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06316999
Other study ID # 23-012169
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date June 2025

Study information
Verified date March 2024
Source Mayo Clinic
Contact Patricia Kammer, CCRP
Phone (507)538-1827
Email kammer.patricia@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 - Pregnant - Cirrhosis - Inability to provide informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Intestinal Ultrasound
Transabdominal and trans perineal ultrasound of the pouch

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis compared to gold standard of pouchoscopy with biopsies through study completion, an average of 1 year
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