About this trial
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can significantly impair patients' quality of life. Due to its transmural nature (affecting the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula), requiring intestinal resection in approximately half of patients during follow-up. The long-term goal for patients is to maintain a normal life, i.e., without symptoms and without intestinal destruction. To this end, short- and medium-term therapeutic goals have evolved in recent years. Clinical remission is not a sufficient goal, as it has not changed the natural history of the disease. The current goal is to achieve a combination of clinical remission and endoscopic mucosal healing, as this is associated with a reduced risk of adverse outcomes (recurrence of symptoms, hospitalization, intestinal resection).
Transmural healing assessed by MRI is also a promising goal associated with a reduced risk of adverse outcomes (recurrence of symptoms, hospitalization, intestinal resection). Furthermore, it is associated with a lower risk of progression to intestinal destruction, unlike endoscopic remission. In this context, transmural healing could soon become the benchmark in terms of therapeutic objectives for Crohn's disease, particularly in the ileum. Although enteric MRI is better accepted than colonoscopy by patients with Crohn's disease, in the ACCEPT1 study, nearly half of patients (48.6%) reported the need to use an intestinal distension product (PEG, mannitol, etc.) as a significant obstacle to repeating entero-MRI, while more than a third complained of vomiting (33.7%) or severe diarrhea (35.0%) induced by these same products. Being able to do without the use of distension products would significantly improve the acceptability of entero-MRI.
The investigators hypothesize that an enteric MRI without distension would lead to poorer ileal distension but would allow inflammatory activity scores to be assessed on MRI in a manner similar to an examination with distension, and thus would not impact the need for therapeutic intensification.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with Crohn's disease according to European recommendations (ECCO) ≥ 18 years of age
With known or suspected ileal ± colonic involvement
Requiring reassessment of disease inflammatory activity according to the clinician
Able to give informed consent to participate in the research.
Disqualifiers
Isolated colonic Crohn's disease
Resection > 1 m of small intestine
Severe obstructive symptoms defined according to CDOS (Crohn's disease obstructive symptoms score)
Uncontrolled intra-abdominal abscess
Trial design
Crossover
Treatments tested in this trial
MRI
Procedure/SurgeryAll patients included in the study will undergo an MRI without contrast medium in order to compare the inflammatory damage visible on an MRI with contrast agent.
Treatment groups
Trial outcomes
Primary outcomes
Modified Clermont score (C-Score)
quantitative variable, whose concordance will be assessed by Lin's coefficient.
Secondary outcomes
MaRIA score
quantitative variable, whose concordance will be assessed by Lin's coefficient
Transmural inflammatory activity
defined by a C-score \> 0.5, binary variable, whose concordance will be assessed by the kappa coefficient
Numerical acceptability scale
Numerical acceptability scale from 0 to 10 (10 = perfect acceptability)
Numerical scale for intestinal distension
Numerical scale from 0 to 10 (10 = perfect acceptability)
Sponsors and contacts
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