Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001198213
Ethics application status
Approved
Date submitted
10/07/2018
Date registered
18/07/2018
Date last updated
9/11/2021
Date data sharing statement initially provided
8/08/2019
Date results information initially provided
9/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing a targeted biopsy regimen with a targeted and surveillance (Seattle protocol) biopsy regimen in eradicated dysplastic Barrett's oesophagus: a prospective study
Scientific title
Comparing a targeted biopsy regimen with a combined targeted and surveillance (Seattle protocol) biopsy regimen in endoscopically eradicated Barrett’s dysplasia/intramucosal adenocarcinoma: a prospective study
Secondary ID [1] 295472 0
None
Universal Trial Number (UTN)
U1111-1216-9661
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barrett's oesophagus 308736 0
Oesophageal adenocarcinoma 308737 0
Condition category
Condition code
Oral and Gastrointestinal 307673 307673 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 307674 307674 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will be comparing two groups of outcomes in the same patient (ie. they become their own control group) - we will be practicing standard care with regards to endoscopic follow up of eradicated dysplastic Barrett's oesophagus and intramucosal oesophageal adenocarcima. This involves taking targeted biopsies of endoscopically abnormal areas (eg. nodules or ulcers) as well as biopsies from the gastric cardia and along the affected portion of the oesophagus in a systematic manner; four quadrant biopsies every 1cm will be taken as per the Seattle protocol, which is current standard of care. We will be recording the time and resources required for surveillance biopsies as well as the results of these to determine whether omitting these surveillance biopsies as per Seattle protocol in the future would be non-inferior to current standard of practice with regards to histology results and patient outcome; this would significantly save on time and costs associated with the process.

Therefore, the two groups will be as follows:
Control - gastric cardia, targeted and surveillance biopsies
Test - gastric cardia and surveillance biopsies only
Intervention code [1] 301791 0
Diagnosis / Prognosis
Comparator / control treatment
The patient would act as both a 'control' and 'interventional' group as the intervention we are implementing is theoretical.
Control group
Active

Outcomes
Primary outcome [1] 306657 0
Proportion of abnormal biopsies (findings other than neo-squamous epithelium; ie. intestinal metaplasia) found on targeted and surveillance biopsies as per Seattle protocol during upper endoscopy in previously eradicated dysplastic Barrett's oesophagus
Timepoint [1] 306657 0
At time of upper endoscopy
Secondary outcome [1] 349164 0
Time involved with obtaining endoscopic surveillance biopsies as per Seattle protocol. This will be measured using stopwatch timers.
Timepoint [1] 349164 0
At time of upper endoscopy
Secondary outcome [2] 349165 0
Cost involved with obtaining endoscopic surveillance biopsies as per Seattle protocol. The Seattle protocol biopsies are placed in a new specimen pot for each centimetre. The costs for the histological assessment are clearly defined for a single pot of biopsies therefore allowing an exact cost calculation. The costs will be obtained from the Pathology Queensland website (http://hsqapps.hsq.health.qld.gov.au/testlistPQ/default.aspx), which have the cost of various investigations available.
Timepoint [2] 349165 0
At time of upper endoscopy

Eligibility
Key inclusion criteria
Adult patients who have undergone successful Barrett's oesophagus eradication who are currently having follow-up surveillance endoscopies
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with dysplastic Barrett's that have not achieved complete eradication of intestinal metaplasia.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We are aiming for 1000-2000 biopsies of neosquamous epithelium (taken from the site of previously eradicated Barrett's epithelium) as well as all additional targeted and cardia biopsies taken during these procedures. We will be comparing the two aforementioned groups with regards to time taken for procedure, costs, histological results and complications of procedure.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2018
Actual
1/08/2018
Date of last participant enrolment
Anticipated
31/12/2020
Actual
31/12/2020
Date of last data collection
Anticipated
31/12/2020
Actual
31/12/2020
Sample size
Target
150
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11391 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 23290 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 300063 0
Hospital
Name [1] 300063 0
Princess Alexandra Hospital
Country [1] 300063 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Rd Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 299458 0
None
Name [1] 299458 0
Address [1] 299458 0
Country [1] 299458 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300909 0
Metro South Human Research Ethics Committee [EC00167]
Ethics committee address [1] 300909 0
Princess Alexandra Hospital, Centres for Health Research, Level 7, Translational Research Institute 37, Kent Street, WOOLLOONGABBA QLD 4102
Ethics committee country [1] 300909 0
Australia
Date submitted for ethics approval [1] 300909 0
18/06/2018
Approval date [1] 300909 0
04/07/2018
Ethics approval number [1] 300909 0
HREC/18/QPAH/390

Summary
Brief summary
This study is examining two biopsy regimens for surveillance follow-up in patients where Barrett’s oesophagus with dysplasia or cancer has been eradicated.

Who is it for?
You may be eligible for this study if you have undergone successful endoscopic Barrett's oesophagus and/or oesophageal adenocarcinoma eradication and are currently having follow-up surveillance endoscopies.

Study details
All participants will undergo surveillance endoscope and biopsy as per their current standard treatment. The study personnel will record the time taken to take samples and perform economic analysis. Please note there is no additional testing or input required by participants in this study beyond participating in their routine care.

It is hoped this research will demonstrate that a reduced test biopsy regimen is more cost- and time-efficient than the standard biopsy regimen without reducing the surveillance quality.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2873 2873 0 0
/AnzctrAttachments/375546-Study Protocol_LH.doc (Protocol)
Attachments [2] 2874 2874 0 0
/AnzctrAttachments/375546-ssa-18-391 Approved Ltr.pdf (Ethics approval)

Contacts
Principal investigator
Name 85242 0
Dr Luke Hourigan
Address 85242 0
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
QLD 4102
Country 85242 0
Australia
Phone 85242 0
+61731762111
Fax 85242 0
+61731765110
Email 85242 0
[email protected]
Contact person for public queries
Name 85243 0
Dr Alexander Huelsen
Address 85243 0
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
QLD 4102
Country 85243 0
Australia
Phone 85243 0
+61731762111
Fax 85243 0
+61731765110
Email 85243 0
[email protected]
Contact person for scientific queries
Name 85244 0
Dr Alexander Huelsen
Address 85244 0
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
QLD 4102
Country 85244 0
Australia
Phone 85244 0
+61731762111
Fax 85244 0
+61731765110
Email 85244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patients will be de-identified. The details of their demographics and endoscopy and histology results will be attached to a unique identifier number.
When will data be available (start and end dates)?
Data will be available from May 2018 onwards. We are still in the recruiting phase of the trial so there is currently no end date
Available to whom?
Data will be available to anyone who requests this for further evaluation.
Available for what types of analyses?
Meta-analyses or similar trials.
How or where can data be obtained?
By emailing the primary contact.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.