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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03471403




Registration number
NCT03471403
Ethics application status
Date submitted
13/03/2018
Date registered
13/03/2018
Date last updated
28/03/2018

Titles & IDs
Public title
Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Scientific title
Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Secondary ID [1] 0 0
HREC/17/WMEAD/20(5002)
Universal Trial Number (UTN)
Trial acronym
COPDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Familial Adenomatous Polyposis 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
Cancer 0 0 0 0
Head and neck
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
FAP - FAP patients with duodenal adenomas

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of serious and non-serious adverse events - bleeding risk
adenoma recurrence
Timepoint [1] 0 0
Three years
Secondary outcome [1] 0 0
Duration of endoscopic procedure
Timepoint [1] 0 0
Three years
Secondary outcome [2] 0 0
Perforation (peri-procedure and delayed)
Timepoint [2] 0 0
Three years
Secondary outcome [3] 0 0
Pain post procedure - Measured with 0 - 10 scale
Timepoint [3] 0 0
Three years
Secondary outcome [4] 0 0
Hospital readmission
Timepoint [4] 0 0
Three years
Secondary outcome [5] 0 0
Change in Spigelman stage
Timepoint [5] 0 0
Three years

Eligibility
Key inclusion criteria
- Patient's diagnosed with a confirmed diagnosis of FAP (genetic testing) and able to
give informed consent to involvement in trial. For patients who do not speak English,
an interpreter will be asked to translate the informed consent

- Patients already commenced on endoscopic surveillance for FAP.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient's with known strictures/stenosis

- Pregnancy

- Patients who did not consent to study

- Bleeding diathesis

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - 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
The purpose of this study is to collect prospective observational data regarding patients
with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for
duodenal adenomas
Trial website
https://clinicaltrials.gov/show/NCT03471403
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael J Bourke, MBBS
Address 0 0
Country 0 0
Phone 0 0
88905555
Fax 0 0
Email 0 0
michael@citywestgastro.com.au
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable