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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03506321




Registration number
NCT03506321
Ethics application status
Date submitted
13/03/2018
Date registered
24/04/2018
Date last updated
5/07/2019

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
HREC/16/WMEAD/392(4863)
Universal Trial Number (UTN)
Trial acronym
LANS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Adenoma 0 0
Colon Polyp 0 0
Submucosal Invasive Colon Adenocarcinoma 0 0
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - chromoendoscopy, high definition white light and narrow band imaging

Other: LANS - Lesions are assessed with chromoendoscopy, HD-WL & NBI


Diagnosis / Prognosis: 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

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Three years
Secondary outcome [1] 0 0
Accurate histologic correlation as predicted by Kudo pit pattern classification
Timepoint [1] 0 0
Three years
Secondary outcome [2] 0 0
Compare inter-observer agreement of presence of SMIC using high definition imaging and chromoendoscopy
Timepoint [2] 0 0
Three years
Secondary outcome [3] 0 0
Compare the difference between live endoscopic assessment and use of carefully selected endoscopic images to predict SMIC
Timepoint [3] 0 0
Three years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT03506321
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael J Bourke, MBBS
Address 0 0
Country 0 0
Phone 0 0
88905555
Fax 0 0
Email 0 0
michael@citywestgastro.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03506321