Shear-Wave Elastography in Intestinal Fibrosis Evaluation in Crohn's Disease
EL-CHIR
Prospective Study to Evaluate the Role of Shear-Wave Elastography in Predicting the Degree of Intestinal Fibrosis in Patients With Crohn's Disease Who Are Candidates for Surgery - ElChir Study
1 other identifier
interventional
18
1 country
1
Brief Summary
The choice of the optimal timing for surgery in Crohn's disease is a challenging issue and diagnostic tools able to estimate the degree of fibrosis are of great interest in this context. Indeed, inflammatory intestinal loops are more likely to respond to medical therapies, wheareas fibrotic loops need to be treated surgically. Shear-wave elastography, which is a non-invasive and largely available technique for the study of tissue elasticity, is very promising and a recent meta-analysis has evaluated its diagnostic accuracy vs histologic examination in patients with stenosing Crohn's disease, showing encouraging results. Aim of this study is to evaluate the diagnostic agreement between elastographic parameters (mean, median, stability index) and the degree of intestinal fibrosis evaluated on the surgical specimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
June 18, 2020
CompletedFirst Submitted
Initial submission to the registry
March 16, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedSeptember 28, 2023
September 1, 2023
3.5 years
March 16, 2023
September 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
liver stiffness values useful for assessing intestinal fibrosis and inflammation
to identify liver stiffness values (kPa) measured with shear-wave elastography that may predict the degree of bowel wall fibrosis or inflammation
3 months after surgery
Study Arms (1)
Patients
EXPERIMENTALChron's disease patients scheduled for ileo-colonic resection
Interventions
Dynamic contrast-enhanced ultrasound and shear wave elastography are perfomed on target intestinal loop
Eligibility Criteria
You may qualify if:
- diagnosis of ileal or ileo-colonic Crohn's disease
- patients scheduled for elective intestinal resection for Crohn's disease within 30 days from enrollment
- affected intestinal segment detectable in B-mode ultrasound
You may not qualify if:
- diagnosis of IBD other than Crohn's disease
- Crohn's disease without ileal involment
- lack of visualization of affected intestinal tract (eg. obesity)
- hearth failure
- known allergy to ultrasound contrast agents
- pregnancy
- lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Gemelli IRCCS
Roma, 00168, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
March 16, 2023
First Posted
September 28, 2023
Study Start
June 18, 2020
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
September 28, 2023
Record last verified: 2023-09