Real-time Diagnosis of Pseudopolyps During Colonoscopy
Condition: Pseudopolyp; Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Significance: Biopsy of potentially benign pseudopolyps and the surrounding mucosa adds
      expense and prolongs the time of endoscopic procedures. Use of endoscopic technologies could
      decrease the need and expense of endoscopic biopsy for these lesions.

      Hypothesis: Pseudopolyps will have a distinctive pattern with the specialized imaging
      techniques of high definition imaging, narrow band imaging, and endoscopic dye-spraying
      techniques using indigo carmine which will predict diagnosis without biopsy.

      100 patients with inflammatory bowel disease will be enrolled in the study. Following a
      standard bowel preparation, each patient will be evaluated using standard endoscopic
      equipment. All patients will receive a standard bowel preparation (sodium phosphate,
      PEG-3350, or magnesium citrate based preparations). All colonoscopic evaluations will be
      performed for indications unrelated to the present study, including evaluation of response to
      medical treatment, routine surveillance exams for dysplasia, diarrhea, or rectal bleeding.
      Polypoid lesions will be examined using four consecutive methods: (a) high definition white
      light, (b) narrow band imaging, (c) chromoendoscopy (high definition white light with indigo
      carmine dye-spraying), and (d) histologic examination following biopsy. The flat mucosa
      surrounding the polypoid lesions will also be examined using theses four techniques in an
      effort to identify dysplastic tissue associated with these polypoid growths.

      High definition white light is the standard imaging modality used for colonoscopy. Narrow
      band imaging (blue wavelength of light) is also used routinely and is available on all
      current generation colonoscopes with the press of a button. Our division routinely uses
      chromoendoscopy as part of surveillance for dysplasia in patients with inflammatory bowel
      disease. Dye spraying catheters or flushing will be utilized for dye application to mucosa.
      The dye used will be indigo carmine.

      Directed biopsy specimens will then be performed using a multibite forceps for targeted
      biopsies. Routine biopsies will be performed as clinically indicated. Pathology slides will
      be reviewed by the gastrointestinal pathologists at the University of Miami. The
      gastroenterologist's interpretation based on each of the three successive endoscopic methods
      will then be compared to the histologic evaluation with each individual lesion serving as its
      own control.
    

Detailed description: 
      The colonoscopy with biopsies will be done as standard of care; additional biopsies will be
      taken for research purposes as detailed above. All of the imaging techniques are part of the
      accepted standard of care as follows: high definition white light, narrow band imaging,
      chromoendoscopy, and histologic examination following biopsy. Comparison of the predictive
      values of the imaging modalities in predicting histology from biopsy underlies the primary
      question of this research protocol. Cost analysis of modalities versus histology will also be
      performed. Time for use of the individual modalities will be recorded.

      Subjects will be identified by one of the investigators during their outpatient clinic visits
      or while inpatient at University of Miami Hospital. Subjects who meet the inclusion/exclusion
      criteria and are scheduled to undergo a colonoscopy for standard of care purposes will be
      asked to participate in the study. Patients over 18 years of age with a confirmed diagnosis
      of inflammatory bowel disease with plans for routine colonoscopic evaluation and able to
      provide informed consent will be included.
    

Intervention name(s): Endoscopic techniques
Intervention type(s): Other
Intervention description(s): All patients will undergo non-invasive endoscopic techniques considered standard of care in surveillance for dysplasia
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 100 patients with inflammatory bowel disease (IBD) will be enrolled in the
        study. They will be identified from a population of patients undergoing colonoscopy for
        diagnostic purposes with IBD.
      
Keywords: Pseudopolyp; Inflammatory bowel disease