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

Sessile Serrated Adenoma Clinical Trial

— SERRESH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100552
• Other study ID #: 4075
• Status: Completed
• Start date: August 1, 2013
• Est. completion date: January 1, 2017

Study information

• Verified date: June 2023
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenoma
• Sessile Serrated Adenoma

Intervention

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

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Western Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysplasia	Presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging and congruence with histopathology	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
Secondary	Sessile serrated polyp	Determination of a specific polyp as an sessile serrated polyp (SSP)	at the initial procedure compared with histopathology within 1 week. no ongoing determination