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OpenTrials
Completed

NCT Number: NCT03100552

Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study

Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions >= 8mm in size

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

About this study

Observational study Structured endoscopic imaging protocol devised Applied prospectively to sequential SSP >= 8mm detected in a tertiary endoscopic resection cohort Review of specimens by blinded specialist pathologists Review of incongruent cases by endoscopists and pathologists

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients referred to a tertiary endoscopic resection practice with any sessile serrated polyp (SSP) >= 8mm

Exclusion criteria

  • Patients referred to a tertiary endoscopic resection practice without sessile serrated polyps (SSP)

Treatment and study plan

Endoscopic imaging

Diagnostic Test

Analysis of the presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging (high definition white light +- narrow band imaging)

Primary outcomes

  1. Dysplasia

    Time frame: at the initial procedure when the sessile serrated polyp (SSP) is analysed by the endoscopist compared with when the SSP is analysed at histopathology less than one week later. no ongoing determination

    Presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging and congruence with histopathology

Secondary outcomes

  1. Sessile serrated polyp

    Time frame: at the initial procedure compared with histopathology within 1 week. no ongoing determination

    Determination of a specific polyp as an sessile serrated polyp (SSP)

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Acronym: SERRESH

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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