Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the efficacy of SonoVue® in participants with Crohn's disease and ulcerative colitis to various aspects including type of Inflammatory Bowel Disease, disease activity, the need for surgical treatment.
Each patient is subjected to clinical, laboratory and endoscopic evaluation, each eligible patient is assigned to one of the arms:
Arm 1: patients with ulcerative colitis (50 patients) Arm 2: patients with Crohn's disease (50 patients) In each arm, patients are classified according to clinical an endoscopic activity of the disease.
Each patient is subjected to ultrasound examination of the bowel using a Philips iU 22 machine according to a standardized protocol:
CEUS is performed according to the following protocol:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with UC | Experimental | Patients with endoscopically proven UC with various extents of disease activity. Diagnostic Test: Contrast-enhanced Ultrasound |
|
| patients with CD | Experimental | Patients with proven CD with various extents of disease activity Diagnostic Test: Contrast-enhanced Ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-enhanced Ultrasound | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between contrast-enhanced ultrasound time-intensity curves and endoscopic disease activity | Particular time-intensity curve characteristics (AUC, Peak intensity etc.) could correlate with endoscopic activity of ulcerative colitis | [7 days] |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between contrast-enhanced ultrasound time-intensity curves in patients with Crohn disease and fibrosis grade according to morphologic analysis of the resected bowel segment | Particular time-intensity curve characteristics could correlate with grade of fibrosis in the resected bowel segment | [14 days] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larisa P Orlova, M.D. | Contact | +7 499 199 66 86 | lporlova2013@yandex.ru |
| Name | Affiliation | Role |
|---|---|---|
| Larisa P Orlova, M.D. | State Scientific Centre of Coloproctology, Russian Federation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Scientific Centre of Coloproctology | Recruiting | Moscow | 123423 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|