Clinical trial NCT03744130: Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease
Official title: Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Disease
Keywords: Contrast-enhanced Ultrasound
Inflammatory Bowel Disease
CD
UC
SonoVue
Endoscopic activity
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2018-11-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between contrast-enhanced ultrasound time-intensity curves and endoscopic disease activity
timeFrame: [7 days]
Secondary outcomes:
measure: 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
timeFrame: [14 days]
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
affiliation: State Scientific Centre of Coloproctology, Russian Federation
name: Larisa P Orlova, M.D.
role: PRINCIPAL_INVESTIGATOR
References: