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AzTrials

Colonic AdenomaLANSNCT03506321

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

A study testing chromoendoscopy, high definition white light and narrow band imaging in people with Colonic Adenoma and Colon Polyp, run by Western Sydney Local Health District at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
chromoendoscopy, high definition white light and narrow band imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteAustralia
Study dates
7 Feb 2018to 7 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • Westmead Endoscopy Unit

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: Comparative Analysis of the Incremental Benefit of Chromoendoscopy in Addition to High Definition White Light (HD-WL)and Narrow Band Imaging (NBI) for the Prediction of Submucosal Invasive Cancer Within Laterally Spreading Lesions (LSLs) and in Determining the Presence of Residual or Recurrent Adenoma at a Post Endoscopic Resection Scar

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.

Being tested
chromoendoscopy, high definition white light and narrow band imaging
Keywords
colonoscopy, Residual adenoma, Recurrent adenoma
Medical subject headings
Colonic Polyps, Colorectal Neoplasms, Adenoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT03506321
Study groupRoleWhat they receive
LANSOtherLesions are assessed with chromoendoscopy, HD-WL \& NBI
Receives: Diagnostic Test: chromoendoscopy, high definition white light and narrow band imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Three years

Secondary outcomes (3)
  1. Accurate histologic correlation as predicted by Kudo pit pattern classification

    Measured: Three years

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

    Measured: Three years

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

    Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2018
  2. Study start7 Feb 2018
  3. Primary completion7 Mar 2021
  4. Study completion7 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03506321
Sponsor's protocol ID
HREC/16/WMEAD/392(4863)
Acronym
LANS
Status last verified
Mar 2025
First submitted
13 Mar 2018
Last updated
27 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing chromoendoscopy, high definition white light and narrow band imaging in people with Colonic Adenoma and Colon Polyp, run by Western Sydney Local Health District at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03506321, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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