Diagnostic Accuracy of Capsule Endoscopy in Small Bowel Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective study to compare in a blinded fashion four different diagnostic modalities to
      detect active small bowel Crohn's disease: a) colonoscopy with ileoscopy; b) small bowel
      follow through; c) capsule endoscopy; and d) computed tomography enterography.
    

Detailed description: 
      Aims:

      The aims of this study are as follows: 1) to describe the spectrum of small intestinal
      lesions demonstrated by capsule endoscopy (CE) in patients with Crohn's disease; 2) to
      determine the inter-observer agreement for recognizing these small intestinal lesions; 3) to
      determine the sensitivity, positive predictive value, and accuracy of CE, CT enterography,
      small bowel follow-through, colonoscopy with ileoscopy, and all pairwise combinations of
      these examinations with a consensus clinical diagnosis for the diagnosis and evaluation of
      the extent and severity of small intestinal Crohn's disease; 4) to establish a Crohn's
      Disease Capsule Endoscopy Index of Severity (CDCEIS); 5) to describe the spectrum of right
      colon lesions demonstrated by CE in patients with Crohn's disease.

      Study Design and Methods:

      Consecutive adult patients with suspected or definite Crohn's disease seen in the
      Inflammatory Bowel Disease Clinic at Mayo Clinic Rochester will be offered enrollment in a
      prospective observational trial comparing CE with CT enterography, small bowel
      follow-through, colonoscopy, and a consensus clinical diagnosis of Crohn's disease. Seventy
      patients will be enrolled, according to the inclusion and exclusion criteria, and written
      informed consent will be obtained. Co-investigators in the Inflammatory Bowel Disease (IBD)
      Clinic will clinically evaluate all patients, including a history and limited physical
      examination. Patients will undergo clinically indicated laboratory tests. Serum will be
      stored on all patients for other potential laboratory studies. Patients will complete a
      retrospective symptom diary for the week prior to their evaluation at Mayo, and a Crohn's
      Disease Activity Index (CDAI) will be calculated.

      All patients will have a CT enterography with peroral contrast interpreted by a
      co-investigator radiologist. All patients will undergo a clinically indicated colonoscopy
      with ileoscopy by a staff co-investigator (not by C.A.S. or the staff co-investigator
      interpreting the CE), and a Crohn's Disease Endoscopic Index of Severity (CDEIS) will be
      calculated. If no significant small bowel strictures are identified by CT enterography or
      colonoscopy with ileoscopy, then patients will subsequently undergo CE. All CE studies will
      be read separately by C.A.S. (gastroenterology fellow) and a supervising staff
      gastroenterologist co-investigator, each blinded to the other's interpretation. The
      interobserver agreement between C.A.S. and the co-investigator staff will be determined.
      Patients will lastly have a clinically indicated small bowel follow-through interpreted by a
      co-investigator radiologist. All co-investigators will be blinded to the results of the other
      imaging modalities until after interpreting their respective studies.

      Following each imaging procedure, the interpreting physician will complete both small
      intestine and colon anatomy forms. The physician will identify all types of lesions present
      and also give both a global evaluation of the severity of lesions found and a global Crohn's
      disease activity score indicating one of the following: active Crohn's disease, suspicious
      for Crohn's disease, inactive Crohn's disease, or no evidence of Crohn's disease.
      Co-investigators representing each of the diagnostic modalities will meet periodically to
      review those cases where there is disagreement among the imaging procedures with respect to
      the extent and severity of small intestinal Crohn's disease in order to reach a consensus
      clinical diagnosis. This consensus clinical diagnosis will serve as the gold standard against
      which each of the individual imaging modalities is evaluated. Sensitivity, positive
      predictive value, and accuracy of all diagnostic modalities compared to the consensus
      clinical diagnosis will be determined. A Crohn's disease capsule endoscopy index of severity
      (CDCEIS) will be created after the CE studies have been reviewed by investigators from other
      referral centers both inside and outside the United States to determine the inter-observer
      agreement (reproducibility) for each type of small bowel lesion identified by CE. Logistic
      regression analysis with step-wise deletion will then be utilized to create the CDCEIS using
      only those lesions that are reproducible, with the global Crohn's disease endoscopic activity
      score from the CE as the dependent variable.
    

Intervention name(s): Capsule endoscopy, CT enterography, colonoscopy, small bowel follow-through
Intervention type(s): Device
Intervention description(s): Each patient undergoes each of the 4 diagnostic modalities, but the readers are blinded to results of the other 3.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Crohn's disease; capsule endoscopy; computed tomography enterography; colonoscopy; small bowel follow-through