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EL-CHIRProspective 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

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What is being tested

multimodal ultrasound

Diagnostic Test
Who is being recruted

Crohn Disease+3

+ Digestive System Diseases

+ Gastroenteritis

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: June 2020
See protocol details

Summary

Principal SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ContactMaria Assunta Zocco
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 18, 2020

Actual date on which the first participant was enrolled.

This study aims to explore a new way to determine the right time for surgery in patients with Crohn's disease, specifically those with ileal or ileo-colonic involvement. In Crohn's disease, some parts of the intestine may become inflamed or fibrotic (hardened), and knowing the degree of fibrosis can help decide if surgery is needed. Shear-wave elastography, a non-invasive technique that measures tissue stiffness, might be a useful tool for this purpose. The study seeks to compare the results from shear-wave elastography with the actual level of fibrosis found during surgery. This could lead to better decision-making about when surgery should happen, potentially improving patient outcomes. Participants in this study will include patients who are scheduled for ileo-cecal resection surgery due to Crohn's disease. The study involves several steps: first, patients will undergo an ultrasound to locate the affected intestinal loop, followed by a shear-wave elastography test using different machines and methods. After surgery, the fibrosis in the removed tissue will be assessed by a pathologist. Additional tests will include blood samples and the collection of fecal and urine samples for further analysis before and after surgery. These procedures are part of regular clinical practice, with the exception of the additional sample collections, which aim to investigate potential biomarkers related to fibrosis. By comparing these results, researchers hope to find reliable elastography measurements that can predict the presence and severity of intestinal fibrosis.

Official TitleProspective 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
Principal SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ContactMaria Assunta Zocco
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Crohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

3 inclusion criteria required to participate
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

7 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Chron's disease patients scheduled for ileo-colonic resection

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fondazione Policlinico Gemelli IRCCS

Roma, ItalyOpen Fondazione Policlinico Gemelli IRCCS in Google Maps
SuspendedOne Study Center