Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis (DESTIN)

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status: Completed

Conditions: Crohn's Disease

Treatments: Procedure: Pelvic MRI; Procedure: Upper endoscopy; Procedure: Abdominal MRI; Procedure: Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02549976

2015-4

Details and patient eligibility

About

The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.

Full description

Background: Crohn's disease (CD) is a chronic inflammatory disorder of the bowel that is characterized by periods of clinical remission alternating with periods of recurrence. Persistent inflammation is believed to lead to progressive bowel damage that, over time, will manifest in the development of strictures, fistulae, and abscesses. The recent development of the Lemann index allows us to precisely assess digestive damage in CD. The aim of the present study is to evaluate digestive damage and associated predictive factors in CD 5 to 10 years after diagnosis.

Methods: Prospective, multicenter, international, transversal, observational study. Patients who completed the RAPID trial (evaluating the benefits on the course of CD of an early prescription of azathioprine compared with conventional step-care therapy) will be eligible. Digestive damage will be assessed using methods described in the Lemann index protocol, dependent on CD location (abdominal MRI obligatory). The total duration of study participation for 1patient will be ≤4 months.

Aims: The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients over 18 years old
• Active or Inactive Crohn's Disease
• Previously enrolled in RAPID clinical trial

Exclusion criteria

• Pregnant or nursing woman
• Patient with a contraindication or who decline to have study exams (MRI and endoscopy)
• Other medical or psychiatric or serious chronic conditions or according to the physician's discretion that could affect the patient's cooperation or the capacity to follow study procedures.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Evaluation group

Experimental group

Description:

Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations. All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations : * Upper tract location : upper endoscopy * Colorectal location : colonoscopy * Perianal location : pelvic MRI * All patients : abdominal MRI

Treatment:

Procedure: Abdominal MRI

Procedure: Colonoscopy

Procedure: Pelvic MRI

Procedure: Upper endoscopy