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

NCT04899700 | Completed

• 1 other identifier: HCB/2020/0076
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 2

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.

Conditions

Polyp of Colon

Keywords

postpolypectomy scar; Linked color imaging

Outcome Measures

Primary Outcomes (3)

• Number of recurrence on postpolypectomy scars with White light endoscopy

  2 years

• Number of recurrence on postpolypectomy scars with LCI

  2 years

• Number of recurrence on postpolypectomy scars detected with AI

  2 years

Secondary Outcomes (1)

• Elapsed time

  2 years

Study Arms (2)

WLE-LCI

PLACEBO COMPARATOR

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; Other: White light endoscopy

LCI-WLE

ACTIVE COMPARATOR

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; Other: White light endoscopy

Interventions

Linked Color Imaging DEVICE

Inspection of the postpolypectomy scar will be made with Linked Color Imaging

LCI-WLE; WLE-LCI

White light endoscopy OTHER

Inspection of the postpolypectomy scar will be made with White light Endoscopy

LCI-WLE; WLE-LCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inflamatory bowel disease

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• European Society of Gastrointestinal Endoscopy: collaborator

Study Sites (2)

María Pellisé. MD. PhD.

Barcelona, 08036, Spain

Location

Oswaldo ortiz

Barcelona, 08036, Spain

Location

Related Publications (4)

• 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.

  PMID: 30635409 RESULT

• 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.

  PMID: 31711241 RESULT

• 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.

  PMID: 21392504 RESULT

• 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.

  PMID: 29539651 RESULT

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: María Pellisé

Model Details: Colonoscopy will be performed in tandem by two different endoscopist. Patients will be randomized to two groups: * WLE-LCI * LCI-WLE

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: May 24, 2021
• Study Start: November 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)