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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation group | Experimental | 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 :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal MRI | Procedure | Abdominal MRI to realize within 4 months following inclusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Digestive damage | Evaluate digestive damage in Crohn's Disease by using Lemann Index | 5 to 10 years after diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive factors of the digestive damage evolution | Evaluate digestive damage per organ (upper intestinal tract, small bowel, colon or rectum, anal or perianal) by using Lemann Index | 5 to 10 years after diagnosis |
| Predictive factors of the digestive damage evolution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Pariente, MD, PhD | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Principal Investigator |
| Jacques Cosnes, MD | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Clermont-Ferrand | Clermont-Ferrand | 63003 | France | |||
| Hopital Beaujon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25241327 | Background | Pariente B, Mary JY, Danese S, Chowers Y, De Cruz P, D'Haens G, Loftus EV Jr, Louis E, Panes J, Scholmerich J, Schreiber S, Vecchi M, Branche J, Bruining D, Fiorino G, Herzog M, Kamm MA, Klein A, Lewin M, Meunier P, Ordas I, Strauch U, Tontini GE, Zagdanski AM, Bonifacio C, Rimola J, Nachury M, Leroy C, Sandborn W, Colombel JF, Cosnes J. Development of the Lemann index to assess digestive tract damage in patients with Crohn's disease. Gastroenterology. 2015 Jan;148(1):52-63.e3. doi: 10.1053/j.gastro.2014.09.015. Epub 2014 Sep 21. | |
| 23644079 |
| Label | URL |
|---|---|
| Related Info | View source |
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| Upper endoscopy |
| Procedure |
Upper endoscopy to realize within 4 months following inclusion |
|
| Colonoscopy | Procedure | Colonoscopy to realize within 4 months following inclusion |
|
| Pelvic MRI | Procedure | Pelvic MRI to realize within 4 months following inclusion |
|
Determine correlation between Lemann Index and factors measured at diagnosis and then 5 to 10 years after diagnosis. |
| 5 to 10 years after diagnosis |
| Variation of Lemann Index | Variation of Lemann Index 5 to 10 years after diagnosis | 5 to 10 years after diagnosis |
| Clichy |
| 92110 |
| France |
| CHRU Lille | Lille | France |
| CHU NICE | Nice | 06202 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hopital Saint-Antoine | Paris | 75012 | France |
| IMM | Paris | 75014 | France |
| CHU Bordeaux - Pessac | Pessac | 33700 | France |
| Chu Toulouse | Toulouse | 31403 | France |
| Background |
| Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30. |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D005773 | Gastroscopy |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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