Ultrasound Stiffness Imaging in Crohn's Disease
Investigating Ultrasound Stiffness Imaging for Predicting Outcomes in Crohn's Disease
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJuly 30, 2015
July 1, 2015
2.8 years
August 7, 2012
July 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in CDAI Score Over 90 days from Hospital Admission
CDAI score will be assessed at 3 time points: Hospital Admission Hospital Discharge 90-day follow-up
CDAI Score measured over 90 days
Shear Wave Velocity
Ultrasound shear wave velocity measurements in bowel wall
Day 0,3,5,7 of Hospitalization
Secondary Outcomes (1)
Need for Re-hospitalization or Surgery within 90 days of discharge
90 days post discharge
Study Arms (2)
Crohn's Inpatients
Crohn's Inpatients, with clinical small bowel obstruction All undergo ultrasound stiffness imaging (USI) of distal affected ileum.
Crohn's Outpatients
Crohn's Outpatients, starting anti-TNF therapy All undergo ultrasound stiffness imaging (USI) at week 0, 6, 14
Interventions
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.
Eligibility Criteria
Adult patients with Crohn's disease, either: * hospitalized for small bowel obstruction, OR, * undergoing outpatient start of anti-tumor necrosis factor alpha
You may qualify if:
- CDAI score \>220
- if INPATIENT: admission for small bowel obstruction.
- if OUTPATIENT: start of anti-tumor necrosis alpha therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Crohn's and Colitis Foundationcollaborator
Study Sites (1)
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan W Stidham, MD
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 7, 2012
First Posted
August 16, 2012
Study Start
September 1, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
July 30, 2015
Record last verified: 2015-07