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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients with UC

Patients with endoscopically proven UC with various extents of disease activity.

Diagnostic Test: Contrast-enhanced Ultrasound

Group Type EXPERIMENTAL

Contrast-enhanced Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

patients with CD

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

Group Type EXPERIMENTAL

Contrast-enhanced Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Contrast-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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No