Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000402347
Ethics application status
Approved
Date submitted
17/07/2016
Date registered
17/03/2017
Date last updated
4/12/2020
Date data sharing statement initially provided
4/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Endoscopic ablation of dysplastic Barrett’s oesophagus
Scientific title
Endoscopic ablation of dysplastic Barrett’s oesophagus
Secondary ID [1] 289697 0
nil
Universal Trial Number (UTN)
U1111-1185-4732
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barrett's oesophagus 299505 0
oesophageal cancer 299506 0
Condition category
Condition code
Cancer 302009 302009 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic intervention for patients with dysplastic barrett's oesophagus or early oesophageal cancer. Patients will undergo hybrid-Argon plasma coagulation during gastroscopy to ablate the dysplastic tissue. This will involve removal of visible lesions of Barrett’s Oesophagus that will be confirmed by microscopic assessment as part of clinical care. During the gastroscopy a salt-water solution will be injected into the submucosa of the oesophageal wall and thereafter the affected area will be treated with Argon Plasma Coagulation.

The procedure will be performed by dr Saxena, who is a highly qualified gastroenterologist and specialized in the treatment of barretts oesophagus. The procedure will approximately take 30 minutes. Thereafter patients will be followed during a follow-up period of 5 years.
Intervention code [1] 295323 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298965 0
Remission of barrett's neoplasia and metaplasia. This will be assessed by taking biopsies during follow-up.
Timepoint [1] 298965 0
The primary timepjoint is one year after treatment.

Patients undergo endoscopic follow-up after treatment at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months in which biospies will be obtained to review any recurrence of dysplasia.

Secondary outcome [1] 325768 0
The total number of procedures carried out with Hybrid Argon Plasma Coagulation (HAPC) per participant.
It is a prospective trial with a follow-up of 5 years. Review of medical records will be used during follow-up period.
Timepoint [1] 325768 0
5 year follow-up post initial ablation procedure.
Secondary outcome [2] 325769 0
To assess the rates of minor and major complications in patients undergoing HAPC for the treatment of dysplastic Barretts Oesophagus '(BO). This is a composite secondary outcome.
a. Minor complications include pain, dysphagia, gastrointestinal bleeding without need for blood transfusion and a significant drop in hemoglobin (Hb < 2 g/dl), and fever during the first 24 hours.
b. Major complications include strictures that cause dysphagia and require dilatation, perforation, gastrointestinal bleeding with a drop of hemoglobin values (Hb > 2 g/dl) or requiring transfusion and fever persisting for more than 24 hours.

The outcomes will be assessed by the patient charts and questions during follow-up visit
Timepoint [2] 325769 0
5 years follow-up post initial ablation procedure
Secondary outcome [3] 332537 0
To determine the recurrence rates of dysplasia and IM with HAPC. This will be assessed during follow-up by taking biopsies.
Timepoint [3] 332537 0
5 years follow-up post initial ablation procedure
Secondary outcome [4] 332538 0
To assess cost per patient of HAPC for the removal of residual BO. The costs will be assessed based on the costs of equipment that is used, the costs for the procedure, and the costs of complications assessed from hospital medical records.
Timepoint [4] 332538 0
5 years follow-up post initial ablation procedure

Eligibility
Key inclusion criteria
Barrett's oesophagus with low grade dysplasia, high grade dysplasia or T1a adenocarcinoma
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) C value greater than 6 cm using the Prague criteria
b) Prior ER for adenocarcinoma with histological diagnosis of greater than or equal to T1b;
c) Presence of endoscopically visible abnormalities at the time of initial APC treatment (additional endoscopic resection is allowed);
d) Presence of cancer in random biopsies obtained at the mapping endoscopy, 8-12 weeks before initial HAPC treatment without endoscopic resection of cancer lesion for staging;
e) Pregnancy
f) Patients in whom complete eradication is not considered a relevant treatment goal or in whom additional treatment is contraindicated;
g) Patients with incomplete healing post-endoscopic resection despite adequate PPI-medication;
h) Prior ablative therapy in the oesophagus;
i) Significant oesophageal stenosis prior to initial HAPC treatment defined as a stenosis that cannot be passed by a therapeutic endoscope or a stenosis that has been dilated endoscopically before.
j) Presence of esophageal varices
k) Anticoagulant therapy (apart from aspirin or NSAIDS) that cannot be discontinued prior to HAPC or incorrectable hemostatic disorders
l) Life expectancy less than 2 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
pilot study

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2017
Actual
22/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6185 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 18153 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 13619 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 294077 0
Hospital
Name [1] 294077 0
Royal Prince Alfred Hospital
Country [1] 294077 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital
Missenden Rd, Camperdown NSW 2050, Australia
Country
Australia
Secondary sponsor category [1] 292907 0
None
Name [1] 292907 0
Address [1] 292907 0
Country [1] 292907 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295491 0
Ethics Review Committee Royal Prince Alfred hospital
Ethics committee address [1] 295491 0
Research ethics and governance office
Royal Prince Alfred Hospital
Missenden Road, Camperdown NSW 2050
Ethics committee country [1] 295491 0
Australia
Date submitted for ethics approval [1] 295491 0
12/01/2017
Approval date [1] 295491 0
15/05/2017
Ethics approval number [1] 295491 0
X17-0003 and HREC/17/RPAH/2

Summary
Brief summary
The primary purpose of this pilot trial is to evaluate the efficacy and safety of Hybrid-APC ablation for the treatment of Barrett's oesophagus.

Who is it for?
You may be eligible to participate in this trial if you are aged 18-85 years and have been diagnosed with Barrett's oesophagus with low grade dysplasia, high grade dysplasia or T1a adenocarcinoma.

Study details
All participants enrolled in this trial will receive the Hybrid-APC ablation procedure which involves an gastroscopy with use of so called Hybrid-APC ablation. This means that a saline solution (NaCl 0.9%) will be injected into the submucosal lining of the affected area and thereafter the affected tissue will be coagulated using APC. Participants will then be followed up every three months during 5 years of follow-up to assess disease progression and whether any additional procedures are required.

It is hoped that the findings from this pilot trial will provide preliminary information regarding the safety and efficacy of ablation for Barrett's oesophagus, which may be used to inform larger clinical trials in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67482 0
Dr Payal Saxena
Address 67482 0
Dr Payal Saxena, BE(Hons), M Biomed E, MBBS (Hons), FRACP
Gastroenterologist and Interventional Endoscopist
Suite G10, 100 Carillon Ave Newtown 2042 NSW
Country 67482 0
Australia
Phone 67482 0
+61295162033
Fax 67482 0
+61295160778
Email 67482 0
[email protected]
Contact person for public queries
Name 67483 0
Dr Payal Saxena
Address 67483 0
Dr Payal Saxena, BE(Hons), M Biomed E, MBBS (Hons), FRACP
Gastroenterologist and Interventional Endoscopist
Suite G10, 100 Carillon Ave Newtown 2042 NSW
Country 67483 0
Australia
Phone 67483 0
+61295162033
Fax 67483 0
+61295160778
Email 67483 0
[email protected]
Contact person for scientific queries
Name 67484 0
Dr Payal Saxena
Address 67484 0
Dr Payal Saxena, BE(Hons), M Biomed E, MBBS (Hons), FRACP
Gastroenterologist and Interventional Endoscopist
Suite G10, 100 Carillon Ave Newtown 2042 NSW
Country 67484 0
Australia
Phone 67484 0
+61295162033
Fax 67484 0
+61295160778
Email 67484 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.