Assessing the additional benefit of an innovative imaging system for colonoscopy

• Register: ISRCTN
• Last refreshed on: 4 March 2019
• Main ID: ISRCTN10357435
• Date of registration: 18/09/2015
• Prospective Registration: No
• Primary sponsor: CPO Piemonte
• Public title: Assessing the additional benefit of an innovative imaging system for colonoscopy
• Scientific title: Assessing the additional neoplasia yield of FUll Spectrum Endoscopy in a CRC screening setting
• Date of first enrolment: 01/09/2014
• Target sample size: 700
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10357435
• Study type: Interventional
• Study design: Multi-centre stratified randomised parallel trial (Screening)
• Phase: Not Specified

Countries of recruitment

Italy

Contacts

• Name: Carlo Senore

Key inclusion & exclusion criteria

Inclusion criteria:
Consecutive patients aged 50 to 69 years undergoing their first colonoscopy examination in the participating centers following a positive fecal immunochemical test (FIT) performed in the context of a regional mass-screening program.

Exclusion criteria:
1. Personal history of colorectal cancer or advanced adenoma
2. More than one first degree relative with colorectal cancer
3. Inflammatory bowel disease (IBD)
4. Endoscopy within past 5 years


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

1. Colorectal cancer 2. Colorectal adenomas
Cancer
1. Colorectal cancer 2. Colorectal adenomas

Intervention(s)

Patients are randomly allocated into two groups, who will each undergo a colonoscopy. For patients in the first group, a standard white light HD endoscope (Standard Forward View) is used, and for patients in the second group, Full Spectrum Endoscopy (FUSE) technology is used. The two instruments are similar, the only difference being related to the characteristics and number of the lenses. The only difference for the patients might be related to the slightly longer duration of the exam with FUSE technology as it may be more likely to find one or more polyps. IN general a colonscopy is expected to last about 30 minutes. No study related follow-up after the completion of the colonoscopic assessment is planned within this study

Primary Outcome(s)

1. Additional yield of advanced adenomas in patients when using Fuse as compared to SFV
2. Proportion of patients detected with 3 or more adenomas when using Fuse as compared to SFV

Secondary Outcome(s)

1. Overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas detection rate of the two techniques, determined from the information recorded in endoscopist and pathology reports
2. Comparison of the size of multiple lesions detected by the two methods, determined from the information recorded in endoscopist and pathology reports
3. Comparison of the detection rate of neoplasia by colonic site: distal (rectum, sigmoid and descending colon) and proximal (proximal to the descending colon), determined from the information recorded in endoscopist and pathology reports
4. Differences in the surveillance guidelines post-colonoscopy when comparing the two arms, determined from the information recorded in endoscopist and pathology reports
5. Comparison of the time required to reach the cecum, determined from the information recorded in endoscopist and pathology reports
6. Comparison of the withdrawal and total procedure time, determined from the information recorded in endoscopist and pathology reports
7. Assessing the learning curve of participating endoscopists, determined from the information recorded in endoscopist and pathology reports
8. Assessing patient’s experience, measured using a questionnaire administered at the end of the examination
9. Assessing the specific contribution of the additional view estimating the proportion of polyps detected using the additional views only, determined from the information recorded in endoscopist and pathology reports

Secondary ID(s)

351

Source(s) of Monetary Support

Regional Health Authority, Piedmont Region (Italy)

Ethics review

Status:
Approval date:
Contact:

Comitato etico interaziendale AOU Città della Salute e della Scienza, 26/05/2014, ref: N 531

Results

• Results available: Yes
• Date Completed: 31/12/2015