Real-time Diagnosis of Pseudopolyps During Colonoscopy
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/5/2018 |
| Start Date: | September 2011 |
| End Date: | February 2013 |
Real-time Diagnosis of Pseudopolyps During Colonoscopy Using Noninvasive Advanced Endoscopic Techniques - a Prospective Study
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.
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.
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.
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.
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.
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