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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02549976

Acronym

DESTIN

Enrollment

Registered

2015-09-15

Start date

2015-12-31

Completion date

2018-02-28

Last updated

2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's Disease, Digestive Damage, Lemann Index

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREAbdominal MRI

Abdominal MRI to realize within 4 months following inclusion

PROCEDUREUpper endoscopy

Upper endoscopy to realize within 4 months following inclusion

PROCEDUREColonoscopy

Colonoscopy to realize within 4 months following inclusion

PROCEDUREPelvic MRI

Pelvic MRI to realize within 4 months following inclusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Digestive damage	5 to 10 years after diagnosis	Evaluate digestive damage in Crohn's Disease by using Lemann Index

Secondary

Measure	Time frame	Description
Predictive factors of the digestive damage evolution	5 to 10 years after diagnosis	Evaluate digestive damage per organ (upper intestinal tract, small bowel, colon or rectum, anal or perianal) by using Lemann Index
Variation of Lemann Index	5 to 10 years after diagnosis	Variation of Lemann Index 5 to 10 years after diagnosis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026