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Junior / Senior Concordance in Ultrasound Assessment of Crohn's Disease (ECHOCROHN)

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ClinicalTrials.gov Identifier: NCT03439826
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Observational study

Condition or disease
Crohn Disease

Detailed Description:

Crohn's disease is a chronic inflammatory disease of the intestine (IBD), evolving with varying periods of remissions and relapses, characterized by segmental inflammation of the digestive tract, which can be complicated by stenosis, fistulas or even digestive cancers.

The emergence of effective therapeutic strategies has led to the adoption of more ambitious therapeutic objectives that have no longer the improvement of symptoms but a complete cicatrization of the intestinal mucosa as an objective.

The disadvantage of the latter is the need for its evaluation by ilo-colonoscopy, "gold-standard", invasive, not without risks (perforation, anesthesia, hemorrhage), requiring colonic preparation and hospitalization.

In this context, the use of non-invasive markers performed in routine practice (hemogram, VS, CRP, fibrinogen, fecal calprotectin, abdominal ultrasound), predictive of this endoscopic mucosal healing, is a necessity to improve the tolerance of follow-up and allow better adherence by the patient of the therapeutic project. A decrease in health costs could also be associated with the use of these markers.

Abdominal ultrasound is an accessible, inexpensive, non-invasive and non-irradiating imaging medium. It is very useful and has proved its effectiveness in monitoring Crohn's disease to evaluate the activity of the disease in order to predict mucosal healing and to detect complications (stenosis, fistula, abscess) (1, 2, 3). However, especially for the study of the small intestine this act is known to be very dependent on the operator and the conditions of examination (echogenicity of the patient). In addition, few objective criteria have been described in the literature for the study of Crohn's disease (2, 3).

A recent study under submission has developed an ultrasound score of Crohn's disease activity, which through the study of each segment (distal ileum, right colon / transverse / left, sigmoid) using 14 criteria , allowed to rule on the activity of the disease and thus to predict mucosal healing. In this study, which concerned 48 patients, ultrasound scans were performed by radiologists experienced in abdominal pathology. This score was very easy to use and powerful to study the disease activity of each segment with 2 parameters in particular: parietal thickness and changes in fat.

It therefore seems necessary to confirm the simplicity of this ultrasound score in a validation cohort to: in particular to study the inter-observer reproducibility so as to be able to extend the use of this score to non-specialist radiologists.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Junior / Senior Concordance in Ultrasound Assessment of Crohn's Disease (ECHOCROHN)
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Inter-observer reproducibility (junior / senior) of an ultrasound score of Crohn's disease activity [ Time Frame: Baseline ]

    These criteria are to be found on each segment: terminal ileum, right colon, transverse colon, left colon and sigmoid.

    • Normal appearance: yes / no
    • Maximum parietal wall thickness (mm)
    • parietal differentiation: yes / no
    • Ulceration: yes / no
    • Fistula: yes / no
    • Infiltration of peripheral fat: yes / no
    • Sclerolipomatosis: yes / no
    • Stenosis: yes / no

    Criterion for the entire abdominal cavity :

    • Mesangular ganglion> 5mm: yes / no
    • Intraperitoneal fluid effusion: yes / no Abdominal abscess: yes / no
    • dilated handles: yes / no
    • Total length of reach (in mm)
    • Distance to the valve



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed for Crohn's disease
Criteria

Inclusion Criteria:

  • Patients followed for Crohn's disease;
  • Crohn's disease diagnosed in accordance with the criteria of the European Crohn's and Colitis Organization (ECCO);
  • Benefiting from an abdominal ultrasound as part of their usual follow-up;
  • Not having expressed his opposition to participate in the study.

Exclusion Criteria:

  • Persons of legal age subject to legal protection (protection of justice, guardianship, tutorship), persons deprived of their liberty.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439826


Contacts
Contact: Guillaume Bouguen 2 99 28 99 72 ext +33 guillaume.bouguen@chu-rennes.fr
Contact: Alexandre Nevot alexandre.nevot@chu-rennes.fr

Locations
France
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Guillaume Bouguen    2 99 28 99 72 ext +33    guillaume.bouguen@chu-rennes.fr   
Contact: Alexandre Nevot       alexandre.nevot@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Guillaume Bouguen Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03439826     History of Changes
Other Study ID Numbers: 35RC18_3094_ECHOCROHN
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases