Real-time Diagnosis of Pseudopolyps During Colonoscopy

NCT ID: NCT01557387

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-02-28

Brief 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.

Conditions

Pseudopolyp; Inflammatory Bowel Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with pseudopolyps.

No treatment involved in this study.

Endoscopic techniques

Intervention Type: OTHER

All patients will undergo non-invasive endoscopic techniques considered standard of care in surveillance for dysplasia

Interventions

Endoscopic techniques

All patients will undergo non-invasive endoscopic techniques considered standard of care in surveillance for dysplasia

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Olympus America, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Daniel A. Sussman, MD, MSPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel A Sussman, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami Division of Gastroenterology

Locations

University of Miami Hospital and Clinics

Miami, Florida, United States

University of Miami Hospital

Miami, Florida, United States

Countries

United States

References

Sussman DA, Barkin JA, Martin AM, Varma T, Clarke J, Quintero MA, Barkin HB, Deshpande AR, Barkin JS, Abreu MT. Development of Advanced Imaging Criteria for the Endoscopic Identification of Inflammatory Polyps. Clin Transl Gastroenterol. 2015 Nov 19;6(11):e128. doi: 10.1038/ctg.2015.51.

Reference Type: DERIVED

PMID: 26583503 (View on PubMed)

Other Identifiers

20091017

Identifier Type: -

Identifier Source: org_study_id