Study of Narrow Band Imaging in the Characterization of Residual Neoplasia After Endoscopic Piecemeal Mucosal Resection

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2016
• Main ID: NCT02448693
• Date of registration: 15/05/2015
• Prospective Registration: No
• Primary sponsor: Parc de Salut Mar
• Public title: Study of Narrow Band Imaging in the Characterization of Residual Neoplasia After Endoscopic Piecemeal Mucosal Resection CROMOPIE
• Scientific title: Randomised Tandem Colonoscopy of Narrow Band Imaging (NBI) and White Light Endoscopy in Patients With Endoscopic Piecemeal Mucosal Resection
• Date of first enrolment: May 2015
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02448693
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Fausto Riu, MD
• Affiliation: Parc de Salut Mar

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients over 18 years old who underwent a colonoscopy for any reason in the last 12
month

- Patients with a basal colonoscopy findings: =1 polyp removed in a piecemeal fashion
regardless of the size

Exclusion Criteria:

- Diagnosis of a CRC in the basal colonoscopy

- Subjects who neglect to follow-up

- Subjects who do not accept informed consent

- Subjects with high risk of perforation or complications due to sedation, including
patients with comorbidities (ASA IV-V)

- Inadequate bowel preparation for colonoscopy (defined by Boston Bowel Preparation
Score (BBPS): = 5 total points; or 0-1 points in any of the 3 segments of the colon)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Colorectal Neoplasms

Intervention(s)

Device: NBI

Device: WLE

Primary Outcome(s)

Number of residual neoplastic tissue detected with both techniques (NBI versus WLE) [Time Frame: less than 1 year after the basal colonoscopy]

Secondary Outcome(s)

Number of accurate detection of residual neoplastic tissue with morphologic features in both groups (NBI and WLE) compared with histopathology [Time Frame: less than 1 year after the basal colonoscopy]

Number of missed lesions on basal colonoscopy [Time Frame: less than 1 year after the basal colonoscopy]

Secondary ID(s)

CROMOPIE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors