Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

I-Scan Versus High-definition White Light

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Robert Hilsden, University of Calgary
ClinicalTrials.gov Identifier:
NCT01617278
First received: June 4, 2012
Last updated: July 3, 2013
Last verified: July 2013

June 4, 2012
July 3, 2013
January 2012
July 2012   (final data collection date for primary outcome measure)
Mean number of adenomas per colonoscopy [ Time Frame: Colonoscopy report form provided to the physician will be filled out and collected after the procedure (1 hour). All polyps reviewed by pathologist (1 week). ] [ Designated as safety issue: No ]
The "Colonoscopy Report Form" completed by the Physician helps to assess the number of polyps and a endoscopic description (location, size, shape) of these lesions including. Following formal review by the pathologist the polyp classification (e.g. whether it is an adenoma) is determined.
Same as current
Complete list of historical versions of study NCT01617278 on ClinicalTrials.gov Archive Site
  • Number of adenomas detected in the right colon during the second look [ Time Frame: Second look in the right colon and finally withdrawing through the entire colon (approximately 5 min) ] [ Designated as safety issue: No ]
    The planned "Second Look" of the right colon will involve withdrawing from the cecum to hepatic flexure, then re-inserting to the cecum and finally withdrawing through the entire colon. This is to determine if a "Second Look" in the right colon increases the mean number of adenomas detected compared with a single inspection irrespective of the imaging modality.
  • To estimate the recruitment rate [ Time Frame: Upto 8 months ] [ Designated as safety issue: No ]

    Recruitment rates will be reported as follows:

    1. No. of patients given the study invitation letter
    2. No. of patients who return the form as interested
    3. No. of patients who provided informed consent
    4. No. of patients who complete the study protocol
Same as current
Not Provided
Not Provided
 
I-Scan Versus High-definition White Light
A Randomized Controlled Trial Comparing High-definition White Light Colonoscopy to I-Scan Enhanced Colonoscopy for Adenoma Detection in a Population at Increased Risk of Colorectal Cancer. (A Pilot Study)

The purpose of the study is to assess whether the use of I-scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.

Primary Outcome:

To estimate the mean number of adenomas per colonoscopy for both high definition white light colonoscopy and I-scan enhanced colonoscopy

Secondary Outcomes:

  1. To estimate the recruitment rate
  2. Number of adenomas detected in the right colon during the second look

Colorectal Cancer is the third most common cause of cancer in Canada with an estimated lifetime risk of developing the disease of 6-7%. Each year there are approximately 21,000 new cases and 9,100 deaths attributable to this disease. Colonoscopy is one of several methods recommended for CRC screening by current guidelines. While colonoscopy is the most invasive, it offers high diagnostic accuracy and ability for therapy (biopsy and removal of adenomas) compared to other modalities. The emerging evidence regarding missed neoplastic lesions with colonoscopy has resulted in quality initiatives designed to improve colonoscopy performance. I-Scan (Pentax, Montvale, NJ) is a new method that uses post processing computer algorithms to revise the standard white light to highlight pit patterns and vascular surface patterns.The relevant I-scan settings in the colon are I-scan 1 and I-scan 2. The primary objective of the study is to compare the adenoma detection rate in the right colon using High-definition white light colonoscopy versus I-scan enhanced colonoscopy.

All patients referred for a screening colonoscopy at Forzani and MacPhail Colon Cancer Centre will be considered for enrollment.All eligible patients that are not part of another research study will be approached for enrollment into the study. During the pre-assessment at the clinic a study assistant will contact all the eligible patients to describe the study and provide an "Invitation to participate in a Research study" form. The study assistant will obtain a final consent if they agree. Those not interested will simply receive the Centre's standard protocol. There will be no coercion of any sort. Following Informed Consent, treatment allocation through computer generated randomization will be revealed. Patients will be allocated to one of the three study arms (HD Colon, I-scan 1 and I-Scan 2). Patients will receive a standard bowel preparation: Split dose Polyethylene Glycol (PEG) (2L at noon + 2L at 8 PM the day before) for morning procedures or (2L at 8Pm the day before and 2L at five hours before the procedure on the day of colonoscopy) for afternoon procedure. certified gastroenterologists will perform all of the procedures with the assistance of a nurse. The planned "second look" of the right colon will involve withdrawing from the Cecum to Hepatic flexure, then re-inserting to Cecum and finally withdrawing through the entire colon. The physician performing the procedure will then fill a "Colonoscopy Report Form" including the number of polyps detected, size, shape, polypectomy method and cleanliness of the bowel.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Colorectal Cancer
  • Device: I-Scan 1
    I-Scan 1 has contrast enhancement (CE)and surface enhancement (SE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail.CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.
  • Device: HD Colon
    High definition white light
  • Device: I-Scan 2
    I-Scan 2 has contrast enhancement (CE), surface enhancement (SE) and tone enhancement (TE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail.CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.TE provides a uniform colour image and is intended for detailed inspection of distinct lesions.
  • Experimental: I-Scan 1
    I-Scan 1 modality will be used by the endoscopist for the entire procedure
    Intervention: Device: I-Scan 1
  • Experimental: HD Colon
    High definition white light modality will be used by the endoscopist for the entire procedure
    Intervention: Device: HD Colon
  • Experimental: I-scan 2
    I-Scan 2 modality will be used by th endoscopist through out the procedure
    Intervention: Device: I-Scan 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All increased risk patients (Patients with family history or personal history of Colon Polyps or Colon Cancer and FOBT positive) referred for a screening colonoscopy at the Forzani and MacPhail Colon Cancer Centre will be considered for enrollment

Exclusion Criteria:

  • Average risk patients
  • Previous Colon surgery
  • Hereditary Polyposis syndromes
  • Suspected polyps or CRC before colonoscopy that have been suggested by another modality (Barium enema, Virtual colonoscopy, Flexible Sigmoidoscopy)
Both
18 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01617278
23474-P
No
Dr. Robert Hilsden, University of Calgary
University of Calgary
Not Provided
Principal Investigator: Robert Hilsden, MD Faculty of Medicine, University of Calgary
University of Calgary
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP