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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]

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

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

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]

At baseline

Secondary outcome [1]

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]

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?

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]

Self funded/Unfunded

Name [1]

Sujievvan Chandran

Address [1]

Department of Gastroenterology
Austin Health
145 Studley Road Heidelberg
Victoria 3084

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee

Ethics committee address [1]

Research Ethics Unit
Henry Buck Building
Austin Hospital
145 Studley Road, Heidelberg Victoria 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/06/2012

Approval date [1]

12/07/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Sujievvan Chandran

Address

Austin Health
Department of Gastroenterology
145 Studley Road
Heidelberg, Victoria 3084

Country

Australia

Phone

+61394965000

Fax

+61394965183

[email protected]

Contact person for scientific queries

Name

Sujievvan Chandran

Address

Austin Health
Department of Gastroenterology
145 Studley Road
Heidelberg, Victoria 3084

Country

Australia

Phone

+61394965000

Fax

[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

No additional documents have been identified.

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