Trial document




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  DRKS00011727

Trial Description

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Title

Evaluation of small bowel MRI findings for the prediction of the course of Crohn's disease

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Trial Acronym

Prediction of CD course by MRI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Crohn’s disease is a chronic inflammatory disease that can involve the whole gastrointestinal tract. The inflammation can progress to complications like stenoses fistulas that might require surgery. In order to predict the individual course of the disease the knowledge of prognostic parameters is helpful. The involvement of the small bowel seems to be such a predictor.

Magnetic resonance imaging (MRI) is used for the assessment of the small bowel. The planned study evaluates whether small bowel MRI is able to predict the course of Crohn’s disease thereafter. To this, the MRI findings are correlated to clinical endpoints.

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Brief Summary in Scientific Language

Crohn’s disease is a chronic inflammatory bowel disease that runs a disabling course in subset of patients. There is increasing evidence that immunosuppressive therapy can change the course and improve prognosis.
Since particular drugs can induce adverse events and / or produce high costs, only patients at risk should receive those drugs.The inflammatory involvement of the small bowel is discussed as predictor of the course, but diagnostic of the small bowel is difficult and mainly relies on ultrasound and magnetic resonance imaging (MRI).
In a previous study we were able to show that small bowel MRI improves the detection of inflammation and complications.
The planned study is designed to evaluate whether the pattern of small bowel involvement as seen in MRI scan gives a clue for the clinical course thereafter. For this, the MRI scan is correlated with clinical course and endpoints like development of stenoses, fistulas, need for immunosuppressive therapy or surgery.

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Organizational Data

  •   DRKS00011727
  •   2017/03/07
  •   [---]*
  •   yes
  •   Approved
  •   5185-14, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Crohn's disease
  •   K50 -  Crohn disease [regional enteritis]
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Interventions/Observational Groups

  •   Data request (interview) after MRI of the small bowel (e.g. development of stenoses, fistulas, need for immunosuppressive therapy or surgery)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Determination of a prognostic relevant pattern of small bowel involvement
Prognostic relevance of small bowel MRI after 2 years
- Crohn’s disease associated surgery
- Existence of a stenosis
- Existence of a fistula
- Existence of immunosuppressive therapy

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Secondary Outcome

Prognostic relevance of small bowel MRI after 5 years
- Crohn’s disease associated surgery
- Existence of a stenosis
- Existence of a fistula
- Existence of immunosuppressive therapy

Prognostic relevance of small bowel MRI at any time
- Crohn’s disease associated surgery
- Existence of a stenosis
- Existence of a fistula
- Existence of immunosuppressive therapy

Co-morbidities
Extraintestinal manifestations
Perianal disease
Quality of life
Age

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/03/15
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Diagnosis of Crohn's disease
Small bowel MRI from 01/2003 to 12/2014

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Exclusion Criteria

Contact to patient not possible
Lack of informed consent

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Addresses

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    • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil gGmbHAbteilung für Gastroenterologie und Hepatologie
    • Mr.  Prof. Dr.  Wolff  Schmiegel 
    • Bürkle-de-la-Capm-Platz 1
    • 44789  Bochum
    • Germany
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    • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil gGmbH,Medizinische Klinik - Abteilung für Gastroenterologie und Hepatologie
    • Mr.  Dr.  Thorsten  Brechmann 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil gGmbH,Medizinische Klinik - Abteilung für Gastroenterologie und Hepatologie
    • Mr.  Dr.  Thorsten  Brechmann 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil gGmbH
    • Mr.  Prof.  Wolff  Schmiegel 
    • Bürkle-de-la-Capm-Platz 1
    • 44789  Bochum
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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