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ISRCTN
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ISRCTN66817054
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DOI
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10.1186/ISRCTN66817054
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Study on narrow band imaging versus conventional colonoscopy for polyps detection in patients with positive fecal occult blood test undergoing colonoscopy screening
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Scientific title
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Narrow band imaging versus high definition white light colonoscopy for the detection of colorectal polyps in patients with positive fecal occult blood test undergoing colonoscopy screening: results of a prospective randomized controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The use of Narrow Band Imaging (NBI) increases the detection rate of advanced adenomas compared with High Definition White Light colonoscopy (HD-WL)
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Lay summary
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Lay summary under review 2
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Ethics approval
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Ethical Committee: Ethics Committee Intercompany A.O.U.(Comitato etico Interaziendale A.O.U.) San Giovanni Battista di Torino, Corso Bramante 88 10126 Torino (Italy), April 21, 2008, ref - Protocol: CEI/231
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Study design
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Interventional multicentre randomized controlled study
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Patients with positive FOBT harbour a risk of colorectal cancer of about 5% and of advanced adenomas of about 40%
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Participants - inclusion criteria
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All consecutive patients aged 55-64 years, either sex, referred to the Endoscopic Units of Torino and Novara for screening colonoscopy due to positive fecal occult blood test (FOBT)
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Participants - exclusion criteria
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1. Use of antiplatelet agents or anticoagulants that preclude removal of polyps
2. Refusal to participate or inability to give informed consent
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Anticipated start date
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01/05/2008
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Anticipated end date
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01/06/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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600
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Interventions
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A total of six experienced endoscopists each having performed > 5000 standard colonoscopies and > 50 NBI colonoscopies participate in the study. For all the study procedures, high-resolution wide-angle (170 degrees) video colonoscopes with push button switch from WL to NBI (Olympus HD 180 series, Olympus Corp., Hamburg, Germany) will be used.
Patients will be randomized to undergo colonoscopy with either HD-WL or NBI by a computer-generated randomization sequence.
Procedures will be performed with conscious sedation if not refused by the patient. The colonoscope will be inserted into the rectum and advanced to the cecum by using HD-WL modality in each patient and no attempt will be made to detect polyps during insertion. The success of cecal intubation will be assessed by the endoscopist by the identification of the ileocecal valve and the appendix orifice. In patients randomized to the NBI arm, the NBI mode will be switched on at the start of the withdrawal phase. During the withdrawal phase, the endoscopist will carefully explore the whole colon from the cecum to the rectum with the assigned light; the entire procedure time and the withdrawal phase will be timed by the endoscopist by using a stopwatch, which will be blocked whenever a polyp will be found and removed. Bowel preparation will be evaluated and graded as: optimal (minimal amount of liquid stools), sub-optimal (mainly liquid stools, no limitation of the examination), fair (liquid and semisolid stools), inadequate (impossibility to perform a reliable examination, repetition of procedure required).
Polyps detected during each procedure will be documented for their size, location and morphology (pedunculated, sessile, and non-polypoid). Non-polypoid (flat and depressed) lesions are defined as the lesions endoscopically high less than half wide, according to Paris classification.
Polyps will be removed and sent in separate jars for histopathological diagnosis by histopathologist who will be blinded to the coloscopy findings.
The definition of advanced adenoma includes all adenomas with a diameter ≥ 1 cm and/or villous component of at least 25%, and/or high-grade dysplasia.
Diminutive adenomas are defined as those with a diameter ≤ 5 mm.
Cancer is defined as the invasion of malignant cells beyond the muscolaris mucosa. Patients with intramucosal carcinoma or carcinoma in situ will be classified as having high-grade dysplasia.
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Primary outcome measure(s)
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To evaluate whether the use of NBI might increase the detection rate of advanced adenomas compared with High Definition White Light colonoscopy (HD-WL); so, the primary outcome measures will be the overall number of advanced adenomas detected in both groups and the number of advanced adenomas per patient. The definition of advanced adenoma includes all adenomas with a diameter ≥ 1 cm and/or villous component of at least 25%, and/or high-grade dysplasia.
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Secondary outcome measure(s)
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To compare the ADR, defined as the percentage of patients with ≥1 adenomas, and the total number of adenomas. So, the secondary outcome measures will be the overall number of patients with at least one adenoma in both groups and total number of adenomas found in the patients according to their group.
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Sources of funding
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University of Turin, Molinette Hospital, Torino (Italy) - Department of Gastroenterology and Hepatology
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Trial website
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Publications
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Contact name
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Prof
Giorgio
Saracco
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Address
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Department of Gastroenterology
San Luigi Hospital
Regione Gonzole 10
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City/town
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Orbassano
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Zip/Postcode
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10100
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Country
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Italy
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Tel
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+39 011 902 6600
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Fax
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+39 011 902 6799
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Email
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g.saracco@tin.it
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Sponsor
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University of Turin (Italy)
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Address
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Department of Gastroenterology and Hepatology
Molinette Hospital
Corso Bramante 88
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City/town
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Torino
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Zip/Postcode
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10126
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Country
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Italy
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Tel
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+39 011 633 6397
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Fax
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+39 011 633 5927
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Email
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mario.rizzetto@unito.it
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Sponsor website:
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http://www.unito.it
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Date applied
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22/01/2013
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Last edited
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12/03/2013
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Date ISRCTN assigned
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12/03/2013
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