Gastroenterology Unit, Valduce Hospital
Como, 22100, Italy
NCT Number: NCT03690297
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
Looking for future studies?
Notify Me50 year–72 year
All sexes
Interventional
Not applicable
Como, 22100, Italy
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy
Time frame: 1 year
proportion of participants with at least one adenoma (per-patient analysis)
Time frame: 1 year
proportion of participants with at least one advanced adenoma
Time frame: 1 year
total number of detected lesions in each group divided by the total number of participants
Time frame: 1 year
time for mucosal inspection only
Valduce Hospital
Other
Linked Color Imaging (LCI) Versus Standard White-light Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06063720
Artificial Intelligence, Colon Adenoma
Hong Kong
View Trial DetailsNCT03949777
Colon Adenocarcinoma, Colon Adenoma
Tel Aviv, Israel
View Trial DetailsNCT04227795
Colon Adenoma, Colon Cancer
Hong Kong
View Trial DetailsNCT03979690
Colon Adenoma, Colonic Diseases
Hong Kong
View Trial Details