Ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Subjects diagnosed with UC. - Subjects who plan to take endoscopic examinations for assessing the disease activity of UC in daily practice. - Subjects who are 16 years old or older when providing written consent. - Subjects who understand, decide to take part in this study and provide written consent by themselves. Minors need consent from themselves as well as their guardians.
Exclusion criteria
Exclusion criteria: - Subjects who had total or partial colectomy or plan to take such surgery when providing written consent. - Subjects diagnosed with proctitis or an undetermined disease type. - Subjects with suspected concomitant colitis, e.g. infections enteritis, diverticulitis, and ischemic colitis (taking colonoscopy for examining other etiologies). - Subjects with an emergent, critical condition of UC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimation accuracy of a scoring system based on IUS findings developed in this study (SOLID-UC index) for endoscopic remission at 6 months after starting the remission induction therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Intra-/inter-observer agreement rates of each sonographic parameter in each segment of the colon and in the most severely affected part of the colon - Minimal important change of SOLID-UC index - Correlation between changes in SOLID-UC index, in its parameters, and in endoscopic scores - Assessment of reliability and measurement error of SOLID-UC index - Comparison of the predictive accuracy of SOLID-UC index, partial Mayo score, Lichtiger index, and biomarkers for endoscopic remission at 6 months after remission induction treatment | — |
Countries
Japan
Contacts
Kyorin University School of Medicine Department of Gastroenterology and Hepatology