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
  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 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.

  Hide Detailed Description

Detailed Description:

Modern medical therapy in Crohn's disease, including immunomodulators and biologic compounds, has revolutionized disease treatment. However, a significant portion of individuals will not respond to medications, most often due to the development of intestinal fibrosis. Over the course of Crohn's disease repeated episodes of inflammation and abnormal wound healing lead to progressive intestinal fibrosis, strictures, and bowel obstruction. While inflammatory Crohn's disease often responds to medical therapy, predominantly fibrostenotic intestinal disease is unresponsive and requires surgery. Our inability to accurately distinguish intestinal inflammation from fibrosis frequently leads to empiric trials of steroids and immunosuppressive therapies. This often proves futile, delays inevitable surgery, and unnecessarily exposes the patient to medication-related risks for months and sometimes years. At present there are no available means to distinguish medically responsive inflammatory disease from predominately fibrotic intestinal disease. The unmet need in this field is an accurate diagnostic technology to determine which patients will benefit from anti-inflammatory therapy, and which patients should go directly to surgery. Non-invasive ultrasound stiffness imaging (USI) may be a surrogate marker of underlying bowel wall fibrosis that aids in predicting if Crohn's disease will be responsive to medical therapy.

Two USI methods have recently been developed: Ultrasound elasticity imaging (UEI) uses 2D speckle-tracking to measure tissue strain, a surrogate of fibrosis. The second, shear wave imaging (SWI), is a commercially available technology that measures the speed of ultrasonic shear waves through tissue. Shear waves travel more rapidly through stiff tissue. The central hypothesis of this proposal is that ultrasound stiffness imaging (USI) quantitatively distinguishes predominately inflammatory from fibrotic bowel wall thickening, and therefore is predictive of the likelihood of response to medical therapy or the need for surgery.

We plan to objectively test our central hypothesis and attain the objective of this application by pursuing the following three specific aims:

Specific Aim 1 (SA-1): Determine if USI stiffness measurements of intestinal strictures in Crohn's patients admitted with small bowel obstruction predicts response or failure of medical therapy based on CDAI and objective inflammatory biomarkers during index hospitalization and at 90 day follow-up.

Inpatient Inclusion Criteria:

  • Subjects must be 18 years of age or older
  • Previous diagnosis of Crohn's disease with imaging demonstrating involvement of the ileum
  • Hospital admission imaging demonstrating small bowel dilation (to > 3.5 cm)
  • CDAI score of >220.

Inpatient 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.

Specific Aim 2 (SA-2): Determine if USI stiffness measurements of diseased ileum in Crohn's outpatients starting Anti-Tumor Necrosis Factor-Alpha therapy predicts response to medical therapy based on CDAI and objective inflammatory biomarkers.

Outpatient Inclusion Criteria

  • Crohn's patients age 18 and over starting anti-TNF therapy
  • CDAI score > 220 to denote clinical disease activity.

Outpatient 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
  • Current use of prednisone or budesonide
  • Changing anti-TNF due to allergy (including a TNF-induced lupus-like arthritis).
  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 April 23, 2014