NCT03506321

Brief Summary

To compare the incremental benefit of chromoendoscopy in addition to high definition white light and narrow band imaging in predicting submucosal invasion within laterally spreading lesions in the colon and in determining the presence of residual or recurrent adenoma at the post endoscopic resection scar

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

February 7, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2022

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

March 13, 2018

Last Update Submit

March 25, 2025

Conditions

Colonic AdenomaColon PolypSubmucosal Invasive Colon AdenocarcinomaColorectal Cancer

Keywords

colonoscopyResidual adenomaRecurrent adenoma

Outcome Measures

Primary Outcomes (1)

  • Compare chromoendoscopy predictions and HD-WL/NBI predictions of submucosal invasive cancer (SMIC) and residual or recurrent adenoma (RRA) to compare correlation with histological findings

    Three years

Secondary Outcomes (3)

  • Accurate histologic correlation as predicted by Kudo pit pattern classification

    Three years

  • Compare inter-observer agreement of presence of SMIC using high definition imaging and chromoendoscopy

    Three years

  • Compare the difference between live endoscopic assessment and use of carefully selected endoscopic images to predict SMIC

    Three years

Study Arms (1)

LANS

OTHER

Lesions are assessed with chromoendoscopy, HD-WL \& NBI

Diagnostic Test: chromoendoscopy, high definition white light and narrow band imaging

Interventions

chromoendoscopy, high definition white light and narrow band imagingDIAGNOSTIC_TEST

Chromoendoscopy, high definition white light and narrow band imaging are compared for predicting submucosal invasion within laterally spreading lesions in the colon and determining the presence of residual or recurrent adenoma at the post endoscopic resection scar

LANS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
  • Patients referred to Westmead and Auburn Hospital Endoscopy Unit for a colonoscopy for all indications

You may not qualify if:

  • Patient's with known colonic strictures/stenosis
  • Patient's with active inflammatory bowel disease
  • Pregnancy
  • Patients who did not consent to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

Location

Related Publications (1)

  • Sidhu M, Shahidi N, Vosko S, van Hattem WA, Tate DJ, Bourke MJ. Incremental benefit of dye-based chromoendoscopy to predict the risk of submucosal invasive cancer in large nonpedunculated colorectal polyps. Gastrointest Endosc. 2022 Mar;95(3):527-534.e2. doi: 10.1016/j.gie.2021.11.032. Epub 2021 Dec 5.

    PMID: 34875258DERIVED

MeSH Terms

Conditions

Colonic PolypsColorectal NeoplasmsAdenoma

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastrointestinal Endoscopy

Study Record Dates

First Submitted

March 13, 2018

First Posted

April 24, 2018

Study Start

February 7, 2018

Primary Completion

March 7, 2021

Study Completion

February 7, 2022

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

AU(1)