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CompletedNCT03506321LANSUpdated Mar 27, 2025

Comparison of the Benefit of Chromoendoscopy in Addition to High Definition White Light and Narrow Band Imaging for the Prediction of Submucosal Invasive Cancer in Colonic Lesions

An interventional study of chromoendoscopy, high definition white light and narrow band imaging in Colonic Adenoma, Colon Polyp and Submucosal Invasive Colon Adenocarcinoma, sponsored by Western Sydney Local Health District. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Western Sydney Local Health District · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

Wide-field (WF) EMR is now accepted as a safe and effective alternative to surgery for removal of large (>20mm) laterally spreading lesions (LSLs).

Assessment of the risk of submucosal invasive cancer (SMIC) is paramount to determining whether a lesion should be attempted for resection by endoscopic mucosal resection (EMR). Lesions that are at high risk for invading the submucosa should either be referred for surgery or in selected cases may be removed by endoscopic submucosal dissection (ESD) in an en bloc fashion to assess SMIC accurately. Tools to assess the likelihood of SMIC endoscopically include analysis of the Kudo pit-pattern (KPP) combined with assessment of morphology as per Paris classification.

KPP analysis is useful to predict histology based on the microarchitecture of pits, epithelial crests or ridges. It thus provides an assessment of risk of sub-mucosal invasion of superficial lesions. There are five categories; with Type 1 and 2 being non-tumours i.e. benign lesion, as compared to Type 3-5 which are tumours ranging from pre-cancerous adenomas (tubular or villous adenoma) to invasive cancer.

Assessment of lesion morphology at WF-EMR using the Paris Classification and analysis of the surface pit-pattern are an integral part of identifying lesions suitable for EMR.

As per the Paris Classification superficial lesions in the colon are divided into; polypoid, non-polypoid and mixed types. Non-polypoid lesions are further divided into slightly raised (0-IIa), flat (0-IIb), depressed surface (0-IIc) or mixed types such as a flat lesion with a nodule (0-IIa+b). The later generally have a greater risk for sub-mucosal invasion (SMI) than polypoid lesions and can be as high as 35-40%. Flat lesions are referred to as laterally spreading lesions (LSLs) if greater than 10mm. There are two distinct subtypes; non-granular vs granular. Granular LSLs exhibit a lower risk of SMI as compared to non-granular LSLs.

Expert opinion suggests that differentiating the KPP in large LSLs (>20mm) requires chromoendoscopy or magnifying endoscopy. This can be a time intensive process. New advances in optics focusing on manipulating the wavelength of the light source; e.g. narrow band imaging (NBI) with the Olympus platform or Fujinon intelligent colour enhancement (FICE) with Fuji have become readily available, and show potential, particularly when combined with magnification, in discriminating the KPP and therefore predicting risk for SMIC. These technologies essentially provide virtual chromoendoscopy. Their diagnostic accuracy has been shown to be comparable to indigo-carmine chromoendoscopy. Both chromoendoscopy and NBI have shown superiority in accurately differentiating between neoplastic and non-neoplastic lesions as compared to high definition white light (HD-WL) endoscopy. In addition NBI has been shown to have a negative predictive value of 98% in assessing residual or recurrent adenoma (RRA) at an EMR scar.

No studies to date have assessed the use of chromoendoscopy and the subsequent benefit of high-definition imaging (HD-WL + NBI) in predicting SMIC and RRA at an EMR scar.

02

Conditions studied

  • Colonic Adenoma
  • Colon Polyp
  • Submucosal Invasive Colon Adenocarcinoma
  • Colorectal Cancer

Keywords

  • colonoscopy
  • Residual adenoma
  • Recurrent adenoma
03

In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's enrollment of 400 is above the median of 250 across 412 interventional studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

Western Sydney Local Health District is the lead sponsor of 35 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patient's with known colonic strictures/stenosis
  • Patient's with active inflammatory bowel disease
  • Pregnancy
  • Patients who did not consent to study
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • Other
    LANS

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

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

Interventions

  • Diagnostic testchromoendoscopy, high definition white light and narrow band imaging

    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

06

What researchers measure

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

    Time frame: Three years

Secondary outcomes

  1. Accurate histologic correlation as predicted by Kudo pit pattern classification

    Time frame: Three years

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

    Time frame: Three years

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

    Time frame: Three years

07

Study locations

1 site
  • Westmead Endoscopy Unit
    Westmead, New South Wales 2145, Australia
08

References and documents

Publications

  • 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. PubMed 34875258 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03506321
Lead sponsor
Western Sydney Local Health District
Responsible party
Professor Michael Bourke (Director of Gastrointestinal Endoscopy, Western Sydney Local Health District) — Principal investigator
First posted
Apr 24, 2018
Start date
Feb 7, 2018
Primary completion
Mar 7, 2021
Completion
Feb 7, 2022
Last update
Mar 27, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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