Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Clermont-Ferrand

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • MRI

    Procedure/Surgery

    All 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

60 Participants
are divided into 2 treatment groups
Group A: MRI without a distension agentExperimental treatment 1 intervention
Group B: MRI with a distension agentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Clermont score (C-Score)

quantitative variable, whose concordance will be assessed by Lin's coefficient.

Time frame
From enrollement to the end of the follow up at 7th day

Secondary outcomes

1

MaRIA score

quantitative variable, whose concordance will be assessed by Lin's coefficient

Time frame
From enrollement to the end of the follow up at 7th day
2

Transmural inflammatory activity

defined by a C-score \> 0.5, binary variable, whose concordance will be assessed by the kappa coefficient

Time frame
From enrollement to the end of the follow up at 7th day
3

Numerical acceptability scale

Numerical acceptability scale from 0 to 10 (10 = perfect acceptability)

Time frame
From enrollement to the end of the follow up at 7th day
4

Numerical scale for intestinal distension

Numerical scale from 0 to 10 (10 = perfect acceptability)

Time frame
From enrollement to the end of the follow up at 7th day

Other outcomes

Sponsors and contacts

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