Skip to content

Assessment of large colon diminutive polyps via real time colonoscopy visualisation compared with standard practice.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001023842
Acronym
EODDPH
Enrollment
146
Registered
2012-09-24
Start date
2012-09-30
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Sujievvan Chandran
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026