Comparing standard colonoscopy versus colonoscopy associated to a special technique of virtual chromoendoscopy named Fuji Intelligent Colour Enhancement (FICE) in the endoscopic surveillance of ulcerative colitis for neoplasia

Not Applicable

Completed

• Conditions: Oral and Gastrointestinal - Inflammatory bowel disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; ulcerative colitis

• Registration Number: ACTRN12618001712291
• Lead Sponsor: ASST Fatebenefratelli Sacco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-17
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

a previous confirmed diagnosis of UC according to clinical, endoscopic and histological data
- disease duration of at least 8 years since onset of symptoms
- no or mild clinical activity according to a maximum Mayo score of 4 points
- at least one visible, polypoid or non-polypoid lesion during the surveillance colonoscopy, according to the Paris classification

Exclusion Criteria

- proctitis
- coagulopathy
- pregnancy
- melanosis coli
- previous colorectal surgery
- a previous colonoscopy in the last 3 months with unresected neoplasia
- massive pseudopolyposis (set as more than 30 polyps).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To analyze the rate of true positive lesions in the FICE arm compared with the WLE arm, defined as the number of lesions suspected for neoplasia according to the FICE or WLE criteria and confirmed as neoplastic by histology.[after histological evaluation (using histology as reference test for both arms) performed within 72 hours of colonoscopy];To analyze the rate of false negative lesions in the FICE arm compared with the WLE arm, defined as the number of lesions not suspected for neoplasia according to the FICE or WLE criteria but which were diagnosed as neoplastic by histology.[after histological evaluation (using histology as reference test for both arms) performed within 72 hours of colonoscopy]

Secondary Outcome Measures

Name	Time	Method
nil[nil]