Real-time Diagnosis of Pseudopolyps During Colonoscopy

NCT01557387 | Completed

• 1 other identifier: 20091017
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Pseudopolyp; Inflammatory Bowel Disease

Keywords

Pseudopolyp; Inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Patients with pseudopolyps.

No treatment involved in this study.

Other: Endoscopic techniques

Interventions

Endoscopic techniques OTHER

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

Patients with pseudopolyps.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients under 18 years of age.
• Patient unwilling or unable to undergo colonoscopy with biopsies or preparation for colonoscopy.

Sponsors & Collaborators

• University of Miami: lead
• Olympus America, Inc.: collaborator

Study Sites (2)

University of Miami Hospital and Clinics

Miami, Florida, 33136, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 26583503 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Daniel A Sussman, MD, MSPH

  University of Miami Division of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: March 19, 2012
• Study Start: September 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

US (2)