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

NCT03100552 | Completed

• 1 other identifier: 4075
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sessile Serrated Adenoma

Keywords

Colonoscopy; Endoscopic resection; Sessile serrated adenoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sessile serrated polyp

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

Study Arms (1)

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

Interventions

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)

Study population

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to a tertiary endoscopic resection practice with any SSP \>= 8mm

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Related Publications (1)

• Tate DJ, Jayanna M, Awadie H, Desomer L, Lee R, Heitman SJ, Sidhu M, Goodrick K, Burgess NG, Mahajan H, McLeod D, Bourke MJ. A standardized imaging protocol for the endoscopic prediction of dysplasia within sessile serrated polyps (with video). Gastrointest Endosc. 2018 Jan;87(1):222-231.e2. doi: 10.1016/j.gie.2017.06.031. Epub 2017 Jul 13.

  PMID: 28713060 DERIVED

Study Officials

• Michael Bourke, MBBS, FRACP

  WSLHD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 4, 2017
• Study Start: August 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)