Linked Color Imaging Versus White Light Endoscopy for the Evaluation of Scars of Non-pedunculated Polyps. LCI Scar Study. (LCIScar)

August 8, 2022 updated by: María Pellisé, Hospital Clinic of Barcelona

Linked Color Imaging vs. High-definition White Light Endoscopy for the Evaluation of Post-polypectomy Scars of Non-pedunculated Polyps. A Randomized Controlled Cross-over Trial. (LCI-Scar Study).

Careful inspection and evaluation of the post-polipectomy scars of polyps greater than 20 mm looking for residual polyp is mandatory. LCI has demonstrated to improve polyp and adenoma detection rate in previous studies. However, to our knowledge no previous studies have been made for validation of LCI for optical diagnosis of a scar looking for residual neoplasia after a previous polypectomy. We hypothesize that LCI will improve the optical diagnosis of polyp recurrence compared to WLE. So, our aim is to compare the efficacy of linked color imaging for optical diagnosis of post-polypectomy scar recurrence compared with high-definition white light endoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Polypectomy is highly effective in reducing cancer risk by resection of colon cancer precursors: adenomas and serrated lesions1. Despite expertise and good technique, up to 20% of non-pedunculated colorectal polyps larger than 20 mm resected by piecemeal endoscopic mucosal resection (EMR) show scar recurrence2. High recurrence rate implies a higher burden of subsequent surveillance and therapeutic colonoscopies, resulting in patient medicalization and increased costs.

Careful inspection and evaluation of the post-polipectomy scars looking for residual polyp is mandatory. In the past few years several techniques have been developed to improve optical diagnosis. One of them, virtual chromoendoscopy have been developed to overcome laboriousness of conventional chromoendoscopy. A recently a well-designed randomized controlled trial has demonstrated the accuracy of high definition white light endoscopy (WLE) and narrow band imaging (NBI) with or without magnification for diagnosis of scar recurrence after an endoscopic mucosal resection3. High diagnostic values were found for all the modalities but the diagnosis accuracy was higher in NBI with near focus. In cases of high confidence, if the optical diagnosis with NBI plus near focus for scar recurrence is negative, no biopsies are needed3. In view of these findings, the European Society of Gastrointestinal Endoscopy (ESGE) recommends the use of virtual or dye-based chromoendoscopy in addition to WLE for the detection of residual neoplasia in the polypectomy scar after a piecemeal resection.

Fujifilm® (HDTV, ELUXEOTM 700 System, Fujifilm® Tokyo, Japan) has developed a new generation of electronic endoscopy system that employs 4 different-wavelength LEDs as light sources. By changing the intensity of each of 4 LEDs, a white light mode and a Linked Color Imaging (LCI) and Blue Light Imaging (BLI) mode can be obtained. The white light mode is similar to conventional endoscopy using a Xenon lamp while LCI and BLI are the new technologies incorporated the system allowing a bright image-enhanced chromoendoscopy. In both BLI and LCI mode, the peak intensity of the LEDs is set at 410nm±10nm. As this is the peak absorption of light of hemoglobin, microvascular structures at the surface of the mucosa can be distinguished more clearly from blood vessels in the deep mucosa. In contrast to BLI, LCI also acquires the white light in an appropriate balance. The acquired color information is reallocated to differentiate the colors close to the mucosal color, i.e. information for several colors is simultaneously expanded so that the reddish and whitish colors become redder and whiter, respectively. Thereby, mucosal surface patterns are better visualized and this could potentially increase the detection of polyps by improving the visibility of colorectal lesions.

LCI has demonstrated to improve polyp and adenoma detection rate in previous studies5-7. However, to our knowledge no previous studies have been made for validation of LCI for optical diagnosis of a scar looking for residual neoplasia after a previous polypectomy. We hypothesize that LCI will improve the optical diagnosis of polyp recurrence compared to WLE. Therefore, the aim of this study is to evaluate the efficacy of LCI for optical diagnosis of post-polypectomy scar recurrence compared with WLE.

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • María Pellisé. MD. PhD.
      • Barcelona, Spain, 08036
        • Oswaldo ortiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient ≥18 years undergoing surveillance colonoscopy after a previous polypectomy of one or more non-pedunculated polyps greater than 15 mm.
  • Provide informed consent.

Exclusion Criteria:

  • Inflamatory bowel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: WLE-LCI
First endoscopist will perform an optical diagnosis of recurrence of post-polypectomy scar with WLE. Then a second diagnosis will be performed by the same endoscopist with blue light imaging (BLI)
Device: Linked Color Imaging
Inspection of the postpolypectomy scar will be made with Linked Color Imaging
Other: White light endoscopy
Inspection of the postpolypectomy scar will be made with White light Endoscopy
Active Comparator: LCI-WLE
First endoscopist will perform an optical diagnosis of recurrence of post-polypectomy scar with Linked Color Imaging (LCI). Then a second diagnosis will be performed by the same endoscopist with blue light imaging (BLI)
Device: Linked Color Imaging
Inspection of the postpolypectomy scar will be made with Linked Color Imaging
Other: White light endoscopy
Inspection of the postpolypectomy scar will be made with White light Endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of recurrence on postpolypectomy scars with White light endoscopy
Time Frame: 2 years
2 years
Number of recurrence on postpolypectomy scars with LCI
Time Frame: 2 years
2 years
Number of recurrence on postpolypectomy scars detected with AI
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Elapsed time
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

European Society of Gastrointestinal Endoscopy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2020/0076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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