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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)

Primary Purpose

Colonic Adenoma, Colon Polyp, Submucosal Invasive Colon Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
chromoendoscopy, high definition white light and narrow band imaging
Sponsored by
Western Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Adenoma focused on measuring colonoscopy, Residual adenoma, Recurrent adenoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead Endoscopy Unit

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LANS

Arm Description

Lesions are assessed with chromoendoscopy, HD-WL & NBI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Accurate histologic correlation as predicted by Kudo pit pattern classification
Compare inter-observer agreement of presence of SMIC using high definition imaging and chromoendoscopy
Compare the difference between live endoscopic assessment and use of carefully selected endoscopic images to predict SMIC

Full Information

First Posted
March 13, 2018
Last Updated
June 28, 2023
Sponsor
Western Sydney Local Health District
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1. Study Identification

Unique Protocol Identification Number
NCT03506321
Brief Title
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
Acronym
LANS
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
March 7, 2021 (Actual)
Study Completion Date
February 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Sydney Local Health District

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Adenoma, Colon Polyp, Submucosal Invasive Colon Adenocarcinoma, Colorectal Cancer
Keywords
colonoscopy, Residual adenoma, Recurrent adenoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LANS
Arm Type
Other
Arm Description
Lesions are assessed with chromoendoscopy, HD-WL & NBI
Intervention Type
Diagnostic Test
Intervention Name(s)
chromoendoscopy, high definition white light and narrow band imaging
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Accurate histologic correlation as predicted by Kudo pit pattern classification
Time Frame
Three years
Title
Compare inter-observer agreement of presence of SMIC using high definition imaging and chromoendoscopy
Time Frame
Three years
Title
Compare the difference between live endoscopic assessment and use of carefully selected endoscopic images to predict SMIC
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Westmead Endoscopy Unit
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
34875258
Citation
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.
Results Reference
derived

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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

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