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Ultrasound Stiffness Imaging in Crohn's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666626
First Posted: August 16, 2012
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Ryan W. Stidham, University of Michigan
  Purpose
The purpose of this study is to determine whether ultrasound-based assessment of intestinal stiffness in patients with Crohn's disease predicts the effectiveness of medical therapy or the need for surgical resection.

Condition Intervention
Crohn's Disease Ultrasound Intestinal Fibrosis Shear Wave Imaging Acoustic Radiation Force Impulse Procedure: Ultrasound stiffness imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Ultrasound Stiffness Imaging for Predicting Outcomes in Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Ryan W. Stidham, University of Michigan:

Primary Outcome Measures:
  • Change in CDAI Score Over 90 days from Hospital Admission [ Time Frame: CDAI Score measured over 90 days ]

    CDAI score will be assessed at 3 time points:

    Hospital Admission Hospital Discharge 90-day follow-up


  • Shear Wave Velocity [ Time Frame: Day 0,3,5,7 of Hospitalization ]
    Ultrasound shear wave velocity measurements in bowel wall


Secondary Outcome Measures:
  • Need for Re-hospitalization or Surgery within 90 days of discharge [ Time Frame: 90 days post discharge ]
    Telephone follow up with subjects 90 days following index hospitalization to assess need for re-hospitalization or surgery


Enrollment: 30
Study Start Date: September 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Crohn's Inpatients
Crohn's Inpatients, with clinical small bowel obstruction All undergo ultrasound stiffness imaging (USI) of distal affected ileum.
Procedure: Ultrasound stiffness imaging
Subjects will undergo transabdominal ultrasound of the distal intestine. Distal intestine motion capture will be used for off-line stiffness assessment by two-dimensional speckle tracking. In addition, shear wave imaging will be used for real-time stiffness assessment.
Crohn's Outpatients
Crohn's Outpatients, starting anti-TNF therapy All undergo ultrasound stiffness imaging (USI) at week 0, 6, 14
Procedure: Ultrasound stiffness imaging
Subjects will undergo transabdominal ultrasound of the distal intestine. Distal intestine motion capture will be used for off-line stiffness assessment by two-dimensional speckle tracking. In addition, shear wave imaging will be used for real-time stiffness assessment.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with Crohn's disease, either:

  • hospitalized for small bowel obstruction, OR,
  • undergoing outpatient start of anti-tumor necrosis factor alpha
Criteria

Inclusion Criteria:

  • CDAI score >220
  • if INPATIENT: admission for small bowel obstruction.
  • if OUTPATIENT: start of anti-tumor necrosis alpha therapy

Exclusion Criteria:

  • Active Clostridium difficile colitis/enteritis
  • Presence of abdominal enterocutaneous fistulas in the ultrasound path
  • Prior abdominal hernia repair with mesh placement in the ultrasound path
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666626


Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Crohn's and Colitis Foundation
Investigators
Principal Investigator: Ryan W Stidham, MD University of Michigan
  More Information

Responsible Party: Ryan W. Stidham, Principle Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01666626     History of Changes
Other Study ID Numbers: HUM64431
First Submitted: August 7, 2012
First Posted: August 16, 2012
Last Update Posted: July 30, 2015
Last Verified: July 2015

Keywords provided by Ryan W. Stidham, University of Michigan:
crohn's disease
ultrasound
intestinal fibrosis
shear wave imaging
acoustic radiation force impulse

Additional relevant MeSH terms:
Fibrosis
Crohn Disease
Pathologic Processes
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases