Real-time Diagnosis of Pseudopolyps During Colonoscopy

This study has been completed.
Sponsor:
Collaborator:
Olympus America
Information provided by (Responsible Party):
Daniel A. Sussman, MD, MSPH, University of Miami
ClinicalTrials.gov Identifier:
NCT01557387
First received: August 11, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Pseudopolyp
Inflammatory Bowel Disease
Other: Endoscopic techniques

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Real-time Diagnosis of Pseudopolyps During Colonoscopy Using Noninvasive Advanced Endoscopic Techniques - a Prospective Study

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Accuracy of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis [ Time Frame: 2 years or until 100 patients enrolled, whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis [ Time Frame: 2 years or until 100 patients enrolled, whichever comes first ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: September 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with pseudopolyps.
No treatment involved in this study.
Other: Endoscopic techniques
All patients will undergo non-invasive endoscopic techniques considered standard of care in surveillance for dysplasia

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557387

Locations
United States, Florida
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
University of Miami Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Olympus America
Investigators
Principal Investigator: Daniel A Sussman, MD, MSPH University of Miami Division of Gastroenterology
  More Information

No publications provided

Responsible Party: Daniel A. Sussman, MD, MSPH, Principal Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT01557387     History of Changes
Other Study ID Numbers: 20091017
Study First Received: August 11, 2011
Last Updated: April 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Pseudopolyp
Inflammatory bowel disease

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014