Assessing the additional neoplasia yield of FUll Spectrum Endoscopy (FUSE™) in a CRC screening setting

Objectives, structure and design of the Study

Study design

To compare the additional diagnostic yield obtained by using the FUSE™ extended view to the yield obtained by the Standard forward-view colonoscopy. As the risk of progression is higher for large than for small adenomas the specific contribution of the new technique in reducing the miss rate of large neoplasms represents an important outcome to be assessed in the study. Also, given the suggested association of a higher miss-rate of serrated and flat lesions with an increased risk of early post-colonoscopy CRC, the added value of the new technique in reducing the miss rate of these lesions will be assessed.

Primary objective

Assessing the additional yield of advanced adenomas and the proportion of patients detected with 3 or more adenomas (serrated adenomas will be also be considered in the calculation) in patients when using FUSE™ as compared to SFV.

Secondary objectives

  • Comparing overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas detection rate of the two techniques.
  • Comparison of the size of multiple lesions detected by the two methods
  • Comparison of the detection rate of neoplasia by colonic site: distal (rectum, sigmoid and descending colon) and proximal (proximal to the descending colon)
  • Differences in the surveillance guidelines post-colonoscopy when comparing the two arms
  • Comparison of the time required to reach the cecum
  • Comparison of the withdrawal and total procedure time
  • Assessing the learning curve of participating endoscopists
  • Assessing patient's experience
  • Assessing the specific contribution of the additional view estimating the proportion of polyps detected using the additional views only

Sample size

We plan to enroll 300 subjects in each study arm. Based on the observed prevalence of adenomas (40%), advanced adenomas (25%), adenomas (33%) and flat lesions (4%) among patients with a positive FIT in the regional screening programme, this sample size allows for a 80% power to detect as statistical significant (α=0.05; two-sided test) a 11.5%, 10.5% and 6% absolute increase in the detection rate of adenomas, advanced adenomas and flat lesions respectively in the FUSE™ arm.

Number of Centers and location of the Study

7 Centers in Italy

Study start date

July 2014