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

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis; Pouchitis
• Interventions: Diagnostic Test: Intestinal Ultrasound

• Registration Number: NCT06316999
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-19
• Study Start: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 109

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
• Decompensated Cirrhosis
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Pouchitis	Intestinal Ultrasound	Transabdominal and transperineal ultrasounds of the pouch will be performed by an experienced sonographer for each patient and interpreted by a board-certified radiologist specializing in IUS.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis	through study completion, an average of 1 year	compared to gold standard of pouchoscopy with biopsies

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States