Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001023842
Ethics application status
Approved
Date submitted
19/09/2012
Date registered
24/09/2012
Date last updated
24/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of large colon diminutive polyps via real time colonoscopy visualisation compared with standard practice.
Scientific title
For adult patients undergoing colonoscopy with diminutive (<5mm) colonic polyps, is endoscopic optical diagnosis of polyp histology comparable to histopathological examination and if so whether colonoscopy surveillance based on endoscopic assessment is cost effective compared to current strategies.
Secondary ID [1] 281271 0
Nil
Universal Trial Number (UTN)
U1111-1134-8802
Trial acronym
EODDPH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diminutive (<5mm) colonic polyps 287469 0
Condition category
Condition code
Oral and Gastrointestinal 287801 287801 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Endoscopic optical diagnosis of diminutive colonic polyps, utilizing standard white light endoscopy and other diagnostic optical features such as narrow band imaging (NBI).
The procedures average time of the procedure would be 20-30minutes
Open to recruitment for 2years or until sample size reached.
Intervention code [1] 285740 0
Diagnosis / Prognosis
Comparator / control treatment
Standard treatment which involves the current gold standard, histological assessment of the colonic polyps.
Patients undergo both optical diagnosis and standard treatment, therefore not impacting on patient care.
Control group
Active

Outcomes
Primary outcome [1] 288020 0
Primary outcome to assess the accuracy of optical endoscopic diagnosis of diminutive colonic polyps.

The endoscopist will be asked to make an endoscopic diagnosis of the diminutive colonic polyp at the time of the procedure and record this down in addition to suggesting a surveillance interval based on NHMRC guidelines based on the endoscopic assessment. Endoscopic analysis will be performed with standard white light examination in addition to narrow band imaging (NBI) which is an optical image enhancement technology incorporated into Olympus colonoscopies used in our department. NBI enhances the visibility of vessels and other structures on mucosal surface which aides optical diagnosis of colonic pathology. The polyps will then be sent to pathology as per standard practice. At the end of the study period the endoscopists optical assessment will be compared with the histological diagnosis.
Timepoint [1] 288020 0
At baseline
Secondary outcome [1] 299294 0
If optical assessment is comparable, to then review whether a cut and discard method would be a safe and cost effective strategy.
"Cut and dischard" method refers to the resection and discarding the polyp tissue rather than sending the polyp tissue for histological assessment.

Safety would be dictated by the rate of dysplasia/malignancy identified in diminutive polyps therefore assessing whether a cut and discard approach to polyps this size would be clinically appropriate.

A cost benefit analysis would be performed at the end of the study if optical diagnosis has been shown to be comparable. The cost of tissue transportation, histological assessment and subsequent cost of hospital follow up would all be included.
Timepoint [1] 299294 0
At baseline

Eligibility
Key inclusion criteria
Adults aged >18.
Complete colonoscopy
Use of high definition Olympus colonoscopes with narrow band imaging.
Satisfactory or good bowel preparation.
>1 polyp which are < 5mm in size.
Operators: Consultant gastroenterologists
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with underlying inflammatory bowel disease, primary sclerosing cholangitis or previous colon cancer.
Poor bowel preparation at the time of colonoscopy.
Incomplete colonoscopy
Polyp specimen not retrieved for analysis.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286037 0
Self funded/Unfunded
Name [1] 286037 0
Sujievvan Chandran
Country [1] 286037 0
Australia
Primary sponsor type
Individual
Name
Sujievvan Chandran
Address
Department of Gastroenterology
Austin Health
145 Studley Road Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 284850 0
None
Name [1] 284850 0
Address [1] 284850 0
Country [1] 284850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288084 0
Human Research Ethics Committee
Ethics committee address [1] 288084 0
Research Ethics Unit
Henry Buck Building
Austin Hospital
145 Studley Road, Heidelberg Victoria 3084
Ethics committee country [1] 288084 0
Australia
Date submitted for ethics approval [1] 288084 0
01/06/2012
Approval date [1] 288084 0
12/07/2012
Ethics approval number [1] 288084 0
H2012/04684

Summary
Brief summary
Polyps which are tiny growths in the large intestine can be classified into two categories: adenomas which have a potential to transform into large intestine cancer compared with hyperplastic polyps with minimal potential to transform into cancer. Majority of polyps found at colonoscopy are small (<6-9mm) or diminutive (<5mm) and half of these are hyperplastic. The current gold standard for assessing what category the large intestine polyp falls under is histology (review of the tissue under a microscope), however this results in significant cost to the health system in the form of specimen transportation and pathologists assessment. This delay in polyp diagnosis also leads to indirect costs such as outpatient clinic review post procedure to discuss timing of surveillance colonoscopy pending histological diagnosis of colonic polyps. Advancements in colonoscopy technology has led to improvements in the ability to diagnose the polyp category visually during the procedure (optical diagnosis) which would allow the polyp tissue to be discarded and a surveillance date for repeat endoscopy provided directly after the procedure circumventing the need for review in the outpatient setting.
Our aim is to assess the accuracy of optical diagnosis by consultant gastroenterologists in comparison to the gold standard of histology for diminutive large intestine polyps. Secondary end point includes cost benefit analysis of resect and discarding diminutive polyps based on optical diagnosis. The importance of this study relates to possible impact on costs to the health care system. There will be no impact on patients as standard practice of polyp resection and histological assessment will remain unchanged. Instead endoscopists will be asked to document polyp histology based on optical diagnosis and subsequent surveillance colonoscopy interval based on current NHMRC guidelines on data collection sheets post procedure separate to the colonoscopy report. Due to the nature of data collection, the patient will not be required to give up any of their time to participate in this study. In terms of safety this study does not involve changes to standard endoscopic practice and therefore safety precautions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34739 0
Address 34739 0
Country 34739 0
Phone 34739 0
Fax 34739 0
Email 34739 0
Contact person for public queries
Name 17986 0
Sujievvan Chandran
Address 17986 0
Austin Health
Department of Gastroenterology
145 Studley Road
Heidelberg, Victoria 3084
Country 17986 0
Australia
Phone 17986 0
+61394965000
Fax 17986 0
+61394965183
Email 17986 0
[email protected]
Contact person for scientific queries
Name 8914 0
Sujievvan Chandran
Address 8914 0
Austin Health
Department of Gastroenterology
145 Studley Road
Heidelberg, Victoria 3084
Country 8914 0
Australia
Phone 8914 0
+61394965000
Fax 8914 0
Email 8914 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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