Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03100552




Registration number
NCT03100552
Ethics application status
Date submitted
22/03/2017
Date registered
4/04/2017
Date last updated
29/06/2023

Titles & IDs
Public title
Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study
Scientific title
Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study
Secondary ID [1] 0 0
4075
Universal Trial Number (UTN)
Trial acronym
SERRESH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sessile Serrated Adenoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Endoscopic imaging

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.


Diagnosis / Prognosis: Endoscopic imaging
Analysis of the presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging (high definition white light +- narrow band imaging)
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dysplasia
Timepoint [1] 0 0
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 outcome [1] 0 0
Sessile serrated polyp
Timepoint [1] 0 0
at the initial procedure compared with histopathology within 1 week. no ongoing determination

Eligibility
Key inclusion criteria
* Patients referred to a tertiary endoscopic resection practice with any sessile serrated polyp (SSP) >= 8mm
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients referred to a tertiary endoscopic resection practice without sessile serrated polyps (SSP)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions \>= 8mm in size
Trial website
https://clinicaltrials.gov/study/NCT03100552
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke, MBBS, FRACP
Address 0 0
WSLHD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03100552