Linked Color Imaging Versus White Light Endoscopy for the Evaluation of Scars of Non-pedunculated Polyps. LCI Scar Study. (LCIScar)
Primary Purpose
Polyp of Colon
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Linked Color Imaging
White light endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Polyp of Colon focused on measuring postpolypectomy scar, Linked color imaging
Eligibility Criteria
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
Sites / Locations
- María Pellisé. MD. PhD.
- Oswaldo ortiz
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
WLE-LCI
LCI-WLE
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Number of recurrence on postpolypectomy scars with White light endoscopy
Number of recurrence on postpolypectomy scars with LCI
Number of recurrence on postpolypectomy scars detected with AI
Secondary Outcome Measures
Elapsed time
Full Information
NCT ID
NCT04899700
First Posted
November 12, 2020
Last Updated
August 8, 2022
Sponsor
Hospital Clinic of Barcelona
Collaborators
European Society of Gastrointestinal Endoscopy
1. Study Identification
Unique Protocol Identification Number
NCT04899700
Brief Title
Linked Color Imaging Versus White Light Endoscopy for the Evaluation of Scars of Non-pedunculated Polyps. LCI Scar Study.
Acronym
LCIScar
Official Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
European Society of Gastrointestinal Endoscopy
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Colon
Keywords
postpolypectomy scar, Linked color imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Colonoscopy will be performed in tandem by two different endoscopist.
Patients will be randomized to two groups:
WLE-LCI
LCI-WLE
Masking
Participant
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WLE-LCI
Arm Type
Placebo Comparator
Arm Description
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)
Arm Title
LCI-WLE
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Linked Color Imaging
Intervention Description
Inspection of the postpolypectomy scar will be made with Linked Color Imaging
Intervention Type
Other
Intervention Name(s)
White light endoscopy
Intervention Description
Inspection of the postpolypectomy scar will be made with White light Endoscopy
Primary Outcome Measure Information:
Title
Number of recurrence on postpolypectomy scars with White light endoscopy
Time Frame
2 years
Title
Number of recurrence on postpolypectomy scars with LCI
Time Frame
2 years
Title
Number of recurrence on postpolypectomy scars detected with AI
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Elapsed time
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
María Pellisé. MD. PhD.
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Oswaldo ortiz
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30635409
Citation
Kandel P, Brand EC, Pelt J, Ball CT, Chen WC, Bouras EP, Gomez V, Raimondo M, Woodward TA, Wallace MB; EMR SCAR Group. Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project for Endoscope (ESCAPE) trial). Gut. 2019 Sep;68(9):1633-1641. doi: 10.1136/gutjnl-2018-316574. Epub 2019 Jan 11.
Results Reference
result
PubMed Identifier
31711241
Citation
Bisschops R, East JE, Hassan C, Hazewinkel Y, Kaminski MF, Neumann H, Pellise M, Antonelli G, Bustamante Balen M, Coron E, Cortas G, Iacucci M, Yuichi M, Longcroft-Wheaton G, Mouzyka S, Pilonis N, Puig I, van Hooft JE, Dekker E. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Dec;51(12):1155-1179. doi: 10.1055/a-1031-7657. Epub 2019 Nov 11. Erratum In: Endoscopy. 2019 Dec;51(12):C6.
Results Reference
result
PubMed Identifier
21392504
Citation
Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8.
Results Reference
result
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
result
Learn more about this trial
Linked Color Imaging Versus White Light Endoscopy for the Evaluation of Scars of Non-pedunculated Polyps. LCI Scar Study.
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