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LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon

Primary Purpose

Adenoma Colon Polyp

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
LCI (Linked color imaging)
Sponsored by
Valduce Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma Colon Polyp

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all outpatients referred for colonoscopy

Exclusion Criteria:

  • inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) < 2 in one colonic segment)
  • previous colonic resection
  • inflammatory bowel disease
  • ereditary polyposic syndromes
  • patients on antithrombotics precluding polyp recetion
  • absence of informed consent
  • inpatients or patients undergoing urgent colonscopy

Sites / Locations

  • Gastroenterology Unit, Valduce HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

WLI (White light Imaging)

LCI (Linked Color Imaging)

Arm Description

Colonoscope withdrawal was performed in the right colon evaluating the mucosa using standard white light.

Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging).

Outcomes

Primary Outcome Measures

Right colon adenoma miss rate
Number of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection

Secondary Outcome Measures

Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate
Number of advanced adenomas identified during the second right coloninspection/ overall number of advanced adenomas identified during the first and the second right colon inspection
Right colon sessile serrated lesions miss rate
Number of sessile serrated lesions identified during the second right coloninspection/ overall number of sessile serrated lesions identified during the first and the second right colon inspection

Full Information

First Posted
August 24, 2017
Last Updated
September 10, 2017
Sponsor
Valduce Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03279783
Brief Title
LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon
Official Title
LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Anticipated)
Study Completion Date
December 30, 2017 (Anticipated)

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
Although colonoscopy with polypectomy can prevent up to 80% of colorectal cancers, a significant adenoma miss rate still exists, particularly in the right colon. Optimizing the detection of adenomas and sessile serrated lesions in the right colon is crucial to increase the effectiveness of colonoscopy in colorectal cancer prevention. Last generation Fuji videocolonscopes incorporates the Linked Color Imaging (LCI), a recently developed technology that differentiates the red colour spectrum more effectively than White Light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. The increased colour contrast results in more accurate delineation of abnormal inflammatory or neoplastic findings of colonic mucosa. Preliminary data suggest that LCI may be improve the detection of neoplastic lesion of colon. The investigators performe a tandem prospective study to compare the right colon adenoma miss rates of LCI colonoscopy with those of conventional white light colonoscopy. Therefore participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back to back fashion, with standard white light (WL) and with LCI. Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first. The endoscopist are masked to group allocation until immediately before the cecum is reached. Examinations are performed with Fuji videocolonscopes series 700 (EC-760R, EC-760ZP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Colon Polyp

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back-to-back fashion, with standard white light (WL) and with LCI (Linked Color Imaging). Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first.
Masking
Participant
Allocation
Randomized
Enrollment
752 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WLI (White light Imaging)
Arm Type
No Intervention
Arm Description
Colonoscope withdrawal was performed in the right colon evaluating the mucosa using standard white light.
Arm Title
LCI (Linked Color Imaging)
Arm Type
Active Comparator
Arm Description
Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging).
Intervention Type
Device
Intervention Name(s)
LCI (Linked color imaging)
Intervention Description
Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging)
Primary Outcome Measure Information:
Title
Right colon adenoma miss rate
Description
Number of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection
Time Frame
One year
Secondary Outcome Measure Information:
Title
Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate
Description
Number of advanced adenomas identified during the second right coloninspection/ overall number of advanced adenomas identified during the first and the second right colon inspection
Time Frame
One year
Title
Right colon sessile serrated lesions miss rate
Description
Number of sessile serrated lesions identified during the second right coloninspection/ overall number of sessile serrated lesions identified during the first and the second right colon inspection
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all outpatients referred for colonoscopy Exclusion Criteria: inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) < 2 in one colonic segment) previous colonic resection inflammatory bowel disease ereditary polyposic syndromes patients on antithrombotics precluding polyp recetion absence of informed consent inpatients or patients undergoing urgent colonscopy
Facility Information:
Facility Name
Gastroenterology Unit, Valduce Hospital
City
Como
ZIP/Postal Code
22100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Radaelli, MD
Phone
0039031324145
Email
francoradaelli01@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29539651
Citation
Paggi S, Mogavero G, Amato A, Rondonotti E, Andrealli A, Imperiali G, Lenoci N, Mandelli G, Terreni N, Conforti FS, Conte D, Spinzi G, Radaelli F. Linked color imaging reduces the miss rate of neoplastic lesions in the right colon: a randomized tandem colonoscopy study. Endoscopy. 2018 Apr;50(4):396-402. doi: 10.1055/a-0580-7405. Epub 2018 Mar 14.
Results Reference
derived

Learn more about this trial

LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon

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