NCT03690297

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 2, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

September 18, 2018

Last Update Submit

October 1, 2019

Conditions

Colon AdenomaColonic Polyp

Keywords

adenoma detection rateLinked Color Imagingcolonoscopy

Outcome Measures

Primary Outcomes (1)

  • Adenoma Detection Rate

    proportion of participants with at least one adenoma (per-patient analysis)

    1 year

Secondary Outcomes (3)

  • advanced adenoma detection rate

    1 year

  • mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions

    1 year

  • Withdrawal time

    1 year

Study Arms (2)

LCI

EXPERIMENTAL

Linked Color Imaging

Device: Linked Color Imaging

WL

ACTIVE COMPARATOR

White Light

Device: Linked Color Imaging

Interventions

Linked Color ImagingDEVICE

Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy

LCIWL

Eligibility Criteria

Age50 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Unit, Valduce Hospital

Como, 22100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 32502550DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Franco Radaelli, MD

    Valduce Hospital, Como

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Head Endoscopy Unit, Valduce Hospital

Study Record Dates

First Submitted

September 18, 2018

First Posted

October 1, 2018

Study Start

October 15, 2018

Primary Completion

June 21, 2019

Study Completion

September 1, 2019

Last Updated

October 2, 2019

Record last verified: 2019-10

Locations

IT(1)