Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease

State Scientific Centre of Coloproctology, Russian Federation

Status: Unknown

Conditions: Inflammatory Bowel Disease

Treatments: Diagnostic Test: Contrast-enhanced Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03744130

34A

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

patients with UC

Experimental group

Description:

Patients with endoscopically proven UC with various extents of disease activity. Diagnostic Test: Contrast-enhanced Ultrasound

Treatment:

Diagnostic Test: Contrast-enhanced Ultrasound

patients with CD

Experimental group

Description:

Patients with proven CD with various extents of disease activity Diagnostic Test: Contrast-enhanced Ultrasound

Treatment:

Diagnostic Test: Contrast-enhanced Ultrasound