Back to resultsLinked Color Imaging (LCI) for Colorectal Adenoma Detection
Primary Purpose
Colon Adenoma, Colonic Polyp
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Linked Color Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Adenoma focused on measuring adenoma detection rate, Linked Color Imaging, colonoscopy
Eligibility Criteria
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.
Sites / Locations
- Gastroenterology Unit, Valduce Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LCI
WL
Arm Description
Linked Color Imaging
White Light
Outcomes
Primary Outcome Measures
Adenoma Detection Rate
proportion of participants with at least one adenoma (per-patient analysis)
Secondary Outcome Measures
advanced adenoma detection rate
proportion of participants with at least one advanced adenoma
mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions
total number of detected lesions in each group divided by the total number of participants
Withdrawal time
time for mucosal inspection only
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03690297
Brief Title
Linked Color Imaging (LCI) for Colorectal Adenoma Detection
Official Title
Linked Color Imaging (LCI) Versus Standard White-light Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Valduce Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma, Colonic Polyp
Keywords
adenoma detection rate, Linked Color Imaging, colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LCI
Arm Type
Experimental
Arm Description
Linked Color Imaging
Arm Title
WL
Arm Type
Active Comparator
Arm Description
White Light
Intervention Type
Device
Intervention Name(s)
Linked Color Imaging
Intervention Description
Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy
Primary Outcome Measure Information:
Title
Adenoma Detection Rate
Description
proportion of participants with at least one adenoma (per-patient analysis)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
advanced adenoma detection rate
Description
proportion of participants with at least one advanced adenoma
Time Frame
1 year
Title
mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions
Description
total number of detected lesions in each group divided by the total number of participants
Time Frame
1 year
Title
Withdrawal time
Description
time for mucosal inspection only
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Radaelli, MD
Organizational Affiliation
Valduce Hospital, Como
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology Unit, Valduce Hospital
City
Como
ZIP/Postal Code
22100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
32502550
Citation
Paggi S, Radaelli F, Senore C, Maselli R, Amato A, Andrisani G, Di Matteo F, Cecinato P, Grillo S, Sereni G, Sassatelli R, Manfredi G, Alicante S, Buscarini E, Canova D, Milan L, Pallini P, Iwatate M, Rondonotti E, Repici A, Hassan C. Linked-color imaging versus white-light colonoscopy in an organized colorectal cancer screening program. Gastrointest Endosc. 2020 Sep;92(3):723-730. doi: 10.1016/j.gie.2020.05.044. Epub 2020 Jun 2.
Results Reference
derived
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Linked Color Imaging (LCI) for Colorectal Adenoma Detection
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