Inflammatory Bowel Disease
Conditions
Keywords
Contrast-enhanced Ultrasound, Inflammatory Bowel Disease, CD, UC, SonoVue, Endoscopic activity
Brief summary
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.
Detailed description
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: * 12h fasting period * exploratory scanning with the use of convex C5-1 probe * detailed scanning with the use of linear L 12-5 probe with Power Doppler * choosing a bowel segment with the most prominent changes * Contrast-enhanced Ultrasound (CEUS) CEUS is performed according to the following protocol: * administration of drotaverine hydrochloride (No-Spa ®) to reduse excessive peristaltic movement * visualization of the previously chosen affected bowel segment with the use of DCE-US (Dynamic Contrast-Enhanced Ultrasound) technology * administration of 2.4 ml SonoVue® intravenously with a bolus injection through a peripheric venous line (left antecubital vein), followed by a 10ml 0.9% Natrium Chloride bolus * the video-loop is acquired during contrast agent administration and wash-out (preferable loop duration - 3 min) * the original DICOM loop is sent to a work station Philips QLab platform is used to acquire a fitted Local Density Random Walk Wash-in Wash-out algorithm (LDRWIWO algorhithm) time-intensity curve of contrast agent wash-in and wash-out. Qualitative and quantitative (Time to peak, Rise time, Mean transit time, Wash-in Slope, Peak intensity, Area under curve, Time from peak to one half) parameters are calculated for each region of interest (ROI).
Interventions
DIAGNOSTIC_TESTContrast-enhanced Ultrasound
1. administration of drotaverine hydrochloride (No-Spa ®) to reduse excessive peristaltic movement 2. visualization of the previously chosen affected bowel segment with the use of DCE-US (Dynamic Contrast-Enhanced Ultrasound) technology 3. administration of 2.4 ml SonoVue® intravenously with a bolus injection through a peripheric venous line (left antecubital vein), followed by a 10ml 0.9% Natrium Chloride bolus 4. the video-loop is acquired during contrast agent administration and wash-out (preferable loop duration - 3 min) 5. the original DICOM loop is sent to a work station
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patient with verified UC/CD aged from 18 to 60y * signed informed consent form for the study
Exclusion criteria
* pregnancy * known allergy or history of adverse reaction to sulfur hexafluoride preparations * marked pulmonary hypertension * uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between contrast-enhanced ultrasound time-intensity curves and endoscopic disease activity | [7 days] | Particular time-intensity curve characteristics (AUC, Peak intensity etc.) could correlate with endoscopic activity of ulcerative colitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | [14 days] | Particular time-intensity curve characteristics could correlate with grade of fibrosis in the resected bowel segment |
Countries
Russia
Contacts
Primary ContactLarisa P Orlova, M.D.
Outcome results
None listed