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 (LANS)

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colon Polyp; Colonic Adenoma; Submucosal Invasive Colon Adenocarcinoma
• Intervention / Treatment: Diagnostic test: chromoendoscopy, high definition white light and narrow band imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen T Goodrick, BN; Phone Number: 88905555; Email: kathleen.goodrick@health.nsw.gov.au

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Endoscopy Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LANS; Lesions are assessed with chromoendoscopy, HD-WL & NBI	Diagnostic test: chromoendoscopy, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Western Sydney Local Health District

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2018
• Primary Completion (Actual): March 7, 2021
• Study Completion (Actual): February 7, 2022

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: April 22, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: colonoscopy; Residual adenoma; Recurrent adenoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Adenoma; Colonic Neoplasms
• Other Study ID Numbers: HREC/16/WMEAD/392(4863)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No