Accuracy of Modified Milan Ultrasound Criteria in Assessing Disease Activity and Severity in Moderate-to-Severe Ulcerative Colitis: a Pilot Study

N/ANot Yet RecruitingNCT07358923

IRCCS San Raffaele25 enrolled

Overview

Longitudinal prospective monocentric observational study in which patients to start Mirikizumab for normal clinical practice will be followed for 24 weeks. Based on the findings in the comparison between US (IUS and TPUS) and endoscopy, the study aim is to build up a modified MUC (Milan Ultrasound Criteria) scoring system taking each colonic segment and the rectum into account, developing non-invasive quantitative ultrasound-based criteria to identify patients with active UC and assess its severity.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ulcerative Colitis (UC)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Confirmed diagnosis of UC according to ECCO guidelines * Patients with active moderate-to-severe disease defined as MES ≥ 2 * Patients undergoing advanced therapies with mirikizumab according to clinical judgement * Patients who provide written informed consent Exclusion Criteria: * Age \< 18 years * Patients with unclassified colitis or other gastrointestinal conditions * Patients with current infections or other severe comorbidity, including liver, kidney or cardiac failure, which contraindicate the initiation of advanced therapy * Patients unable or unwilling to provide consent

Outcomes

Primary Outcomes

To prospectively compare the diagnostic accuracy of modified MUC versus endoscopy (reference standard), in assessing disease activity and severity in UC.