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
multimodal ultrasound
Crohn Disease+3
+ Digestive System Diseases
+ Gastroenteritis
Diagnostic Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Fondazione Policlinico Gemelli IRCCS
Roma, ItalyOpen Fondazione Policlinico Gemelli IRCCS in Google Maps