Inflammatory Bowel Disease Clinical Trial
Official title:
Real-time Diagnosis of Pseudopolyps During Colonoscopy Using Noninvasive Advanced Endoscopic Techniques - a Prospective Study
NCT number | NCT01557387 |
Other study ID # | 20091017 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2011 |
Est. completion date | February 2013 |
Verified date | August 2018 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients equal to or 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. Exclusion Criteria: - Patients under 18 years of age. - Patient unwilling or unable to undergo colonoscopy with biopsies or preparation for colonoscopy. |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Hospital | Miami | Florida |
United States | University of Miami Hospital and Clinics | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | Olympus America, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis | 2 years or until 100 patients enrolled, whichever comes first | ||
Secondary | Cost of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis | 2 years or until 100 patients enrolled, whichever comes first |
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