Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000292471
Ethics application status
Approved
Date submitted
30/05/2007
Date registered
4/06/2007
Date last updated
21/06/2024
Date data sharing statement initially provided
24/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised trial on the efficacy of Ablation vs no Ablation of Barrett's oesophagus with Argon Plasma Coagulation following laparoscopic fundoplication for the reversal of Barrett's oesophagus
Scientific title
Randomised trial on the efficacy of Ablation vs no Ablation of Barrett's oesophagus with Argon Plasma Coagulation following laparoscopic fundoplication for the reversal of Barrett's oesophagus
Secondary ID [1] 287808 0
nil known
Universal Trial Number (UTN)
Trial acronym
Argon Plasma Coaguation post-surgical trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barrett's oesophagus 1834 0
Condition category
Condition code
Other 1927 1927 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention entails coagulating the distal oesophageal mucosa at endoscopy with argon plasma coagulation to try to force conversion of a metaplastic columnar mucosa back to a squamous mucosa.
Intervention code [1] 1789 0
Prevention
Comparator / control treatment
Both the study and control groups are then managed by standard clinical care - ie yearly endoscopy with mucosal biopsies to identify early cancer development in the oesophagus.
Control group
Active

Outcomes
Primary outcome [1] 2741 0
We are determining the outcome at each year of follow-up.
Timepoint [1] 2741 0
Endoscopy is being undertaken yearly and patients will be followed for 20 years.
Secondary outcome [1] 4628 0
Endoscopy is being undertaken yearly and patients will be followed for 20 years.
Timepoint [1] 4628 0
We are determining the outcome at each year of follow-up.

Eligibility
Key inclusion criteria
Presence of Barrett's oesophagus at endoscopy, previous fundoplication
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Reflux not controlled by fundoplication

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope opened in endoscopy room
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
120 Envelopes prepared by independent nurse (60 = treatment, 60=control), and shuffled extensively.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
2 groups - 1 receives standard treatment - regular endoscopy surveillance, and one receives ablation followed by endoscopy surveillance
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/1999
Actual
1/06/1999
Date of last participant enrolment
Anticipated
Actual
1/01/2005
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
100
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4576 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 4577 0
Flinders Medical Centre - Bedford Park

Funding & Sponsors
Funding source category [1] 2072 0
University
Name [1] 2072 0
Department of Surgery, Flinders University
Country [1] 2072 0
Australia
Primary sponsor type
University
Name
Department of Surgery, Flinders University
Address
Bedford Park, SA
Country
Australia
Secondary sponsor category [1] 1877 0
University
Name [1] 1877 0
Department of Surgery, Adelaide University
Address [1] 1877 0
Adelaide
Country [1] 1877 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3845 0
Flinders Medical Centre
Ethics committee address [1] 3845 0
Ethics committee country [1] 3845 0
Australia
Date submitted for ethics approval [1] 3845 0
Approval date [1] 3845 0
18/08/2003
Ethics approval number [1] 3845 0
177/034
Ethics committee name [2] 3846 0
Royal Adelaide Hospital
Ethics committee address [2] 3846 0
Ethics committee country [2] 3846 0
Australia
Date submitted for ethics approval [2] 3846 0
Approval date [2] 3846 0
29/03/1999
Ethics approval number [2] 3846 0
990309

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27892 0
Prof David Watson
Address 27892 0
Dept Surgery
Flinders University
Country 27892 0
Australia
Phone 27892 0
+61882046086
Fax 27892 0
Email 27892 0
[email protected]
Contact person for public queries
Name 10978 0
Professor David Watson
Address 10978 0
Department of Surgery
Flinders Medical Centre
Bedford Park
SA 5042
Country 10978 0
Australia
Phone 10978 0
+61 8 82046086
Fax 10978 0
+61 8 82046130
Email 10978 0
[email protected]
Contact person for scientific queries
Name 1906 0
Professor David Watson
Address 1906 0
Department of Surgery
Flinders Medical Centre
Bedford Park SA 5042
Country 1906 0
Australia
Phone 1906 0
+61 8 82046086
Fax 1906 0
+61 8 82046130
Email 1906 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.