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Ultrasound Stiffness Imaging in Crohn's Disease

This study is not yet open for participant recruitment.
Verified August 2012 by University of Michigan
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Ryan W. Stidham, University of Michigan
ClinicalTrials.gov Identifier:
NCT01666626
First received: August 7, 2012
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  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:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in CDAI Score Over 90 days from Hospital Admission [ Time Frame: CDAI Score measured over 90 days ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Telephone follow up with subjects 90 days following index hospitalization to assess need for re-hospitalization or surgery


Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666626

Contacts
Contact: Carrie Bergmans, BS 734-615-2457 bergmans@umich.edu
Contact: Kay Sauder, BS 734-615-2457

Locations
United States, Michigan
University of Michigan Health System Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Carrie Bergmans, BS     734-615-2457     bergmans@umich.edu    
Principal Investigator: Ryan Stidham, MD            
Sponsors and Collaborators
University of Michigan
Crohn's and Colitis Foundation
Investigators
Principal Investigator: Ryan W Stidham, MD University of Michigan
  More Information

No publications provided

Responsible Party: Ryan W. Stidham, Principle Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01666626     History of Changes
Other Study ID Numbers: HUM64431
Study First Received: August 7, 2012
Last Updated: August 10, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013