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

• Sponsor: Western Sydney Local Health District (Other)
• Overall Status: Completed
• CT.gov ID: NCT03100552
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Actual Duration (Months): 41
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sessile Serrated Adenoma	Diagnostic Test: Endoscopic imaging

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 Design

• Study Type: Observational
• Actual Enrollment: 86 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study
• Actual Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Study population 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.	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)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Hospital	Westmead	New South Wales	Australia	2145

Sponsors and Collaborators

• Western Sydney Local Health District

Investigators

• Principal Investigator: Michael Bourke, MBBS, FRACP, WSLHD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professor Michael Bourke, Clinical Professor of Medicine, Western Sydney Local Health District
• ClinicalTrials.gov Identifier: NCT03100552
• Other Study ID Numbers: 4075
• First Posted: Apr 4, 2017
• Last Update Posted: Mar 23, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Professor Michael Bourke, Clinical Professor of Medicine, Western Sydney Local Health District: Colonoscopy; Endoscopic resection; Sessile serrated adenoma
• Additional relevant MeSH terms: Adenoma

Study Results

No Results Posted as of Mar 23, 2021