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

Completed

• Conditions: Sessile Serrated Adenoma
• Interventions: Diagnostic Test: Endoscopic imaging

• Registration Number: NCT03100552
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2013-08-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Endoscopic imaging	Patients referred to a tertiary endoscopic resection practice found to have an SSP \>= 8mm. Endoscopic imaging applied to the sessile serrated polyp (SSP) to determine the presence or absence of dysplasia.

Primary Outcome Measures

Name	Time	Method
Dysplasia	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 Outcome Measures

Name	Time	Method
Sessile serrated polyp	at the initial procedure compared with histopathology within 1 week. no ongoing determination	Determination of a specific polyp as an sessile serrated polyp (SSP)

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia