Colon Adenoma, Colonic Polyp
Conditions
Keywords
adenoma detection rate, Linked Color Imaging, colonoscopy
Brief summary
Linked color imaging (LCI) is newly developed image-enhancing endoscopy technology that differentiates the red color spectrum more effectively than white light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. This technology, combined in the latest generation Fujifilm's endoscopes (Fujifilm Co, Tokyo, Japan) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with LCI are encouraging but are scanty and limited to back-to back studies. This two parallel arms, randomized, multicenter trial is aimed at evaluating whether LCI is superior to WL endoscopy in terms of adenoma detection
Detailed description
50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT) and meeting all eligibility criteria are randomised 1:1 to LCI (LCI group) or WLI (WL) during insertion and withdrawal phase of colonoscopy. A randomisation list for each participating center was produced by the coordinating center via computer-generated treatment code list. Randomisation is stratified by gender, age (50-60, 61-729 years) and screening history (first vs subsequent test) through an online centralised study database.All procedures are performed with a high-definition ELUXEO 700 series videocolonscopes with or without magnification (EC-760R, EC-760ZP, FUJIFILM Co., Tokyo). The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).
Interventions
DEVICELinked Color Imaging
Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy
Sponsors
Valduce Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* 50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT)
Exclusion criteria
* subjects not eligible for invitation in the screening program (colonoscopy already performed in the previous 5 years, personal history of CRC, colonic adenomas or IBD, severe comorbidity, including end-stage cardiovascular, pulmonary, liver or renal disease) * patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \> 2 in any colonic segment) * patients with previous colonic resection * patients on antithrombotic therapy, precluding polyp resection * patients who were not able or refused to give informed written consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate | 1 year | proportion of participants with at least one adenoma (per-patient analysis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| advanced adenoma detection rate | 1 year | proportion of participants with at least one advanced adenoma |
| mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions | 1 year | total number of detected lesions in each group divided by the total number of participants |
| Withdrawal time | 1 year | time for mucosal inspection only |
Countries
Italy
Outcome results
None listed