Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001189516
Ethics application status
Approved
Date submitted
13/08/2024
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the efficacy of Resection and Plication (RAP) on oesophageal physiology and symptoms in patients with gastro-oesophageal reflux disease (GORD).
Scientific title
Assessing changes in oesophageal physiology and reflux in patients with gastro-oesophageal reflux disease (GORD) after a novel, minimally invasive endoscopic anti-reflux procedure – RAP (Resection and Plication).
Secondary ID [1] 312528 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastro-oesophageal reflux disease (GORD) 334399 0
Condition category
Condition code
Oral and Gastrointestinal 331040 331040 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Resection and Plication (RAP) Procedure. Provided by a trained Gastroenterologist at Sydney Gastroenterology and Liver, Sydney Adventist Hospital. The RAP procedure typically is performed under sedation using an endoscopic approach. Part of the gastric mucosa is resected and sutured to approximate the tissue to create a tighter valve between the stomach and oesophagus. Mucosa is resected using a special endoscopic needle and sutured using a endoscopic suturing device. This procedure may take anywhere from 45 minutes to 120 minutes depending on the patient’s anatomy. The patient will be admitted to the Sydney Adventist Hospital overnight for monitoring but in some limited cases you the patient be able to be discharged home on the same day. Patients will be followed up be phone call a few weeks later to check on progress including any potential side effects.

There is no monitoring of adherence as it is a one-off procedure. However, there will be follow up and assessment of efficacy as described in the 'Outcomes' sections.

Population: Patients with gastro-oesophageal reflux disease that have been referred to the Sydney Gastroenterology and Liver Group and deemed suitable for the Resection and Plication procedure.

Mode:
* The RAP procedure will be delivered once, face-to-face
* Follow-up will be provided via face-to-face, internet and/or telephone communication
* Follow-up will occur for up to 24 months as required.
Intervention code [1] 329044 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338847 0
Change in Acid Exposure Time (AET)
Timepoint [1] 338847 0
once baseline before RAP and once 3-6 months post-RAP.

There also may be further follow ups post-RAP as required, up to 24 months.

Primary outcome [2] 338848 0
Change patients' reported reflux symptoms
Timepoint [2] 338848 0
once baseline pre-RAP and once 3-6 months post-RAP.
There also may be further follow ups post-RAP as required, up to 24 months.
Secondary outcome [1] 437666 0
Change in total number of reflux episodes
Timepoint [1] 437666 0
once baseline before RAP and once 3-6 months post-RAP.

There also may be further follow ups post-RAP as required, up to 24 months.
Secondary outcome [2] 437667 0
Change in Lower Oesophageal Sphincter pressure
Timepoint [2] 437667 0
once baseline before RAP and once 3-6 months post-RAP.

There also may be further follow ups post-RAP as required, up to 24 months.
Secondary outcome [3] 437668 0
Proton Pump Inhibitor use before and after treatment
Timepoint [3] 437668 0
once baseline before RAP and once 3-6 months post-RAP.

There also may be further follow ups post-RAP as required, up to 24 months.
Secondary outcome [4] 440005 0
change in patients' reflux symptoms
Timepoint [4] 440005 0
once baseline pre-RAP and once 3-6 months post-RAP
There may also be further follow ups post-RAP as required up to 24 months
Secondary outcome [5] 440006 0
change in patients' reflux symptoms
Timepoint [5] 440006 0
once baseline pre-RAP and once 3-6 months post-RAP
There may also be further follow ups post-RAP as required up to 24 months
Secondary outcome [6] 440007 0
change in patients' reflux symptoms
Timepoint [6] 440007 0
once baseline pre-RAP and once 3-6 months post-RAP
There may also be further follow ups post-RAP as required up to 24 months

Eligibility
Key inclusion criteria
The main inclusion criterion is that the patient has been deemed appropriate clinically and willing to undergo RAP procedure. The patient must be able to provide informed consent for the procedure and be of 18 years or older.

Patients will have the following physiological and symptomatic characteristics on prior clinical assessments:
• Patients with significant reflux as demonstrated by prolonged acid exposure time (AET) of 6% or more on a pH reflux study.
• Patients with significant reflux symptoms (high symptom association probability, SAP) on a pH reflux study.
• If patients demonstrated borderline AET of 4-6% - high reflux episodes (more than 80) or high SAP
• Patients that are refractory to daily PPI therapy – AET 4% or more on a maximum tolerated acid lowering therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who are not appropriate or eligible for RAP procedure
• Prior anti-reflux procedures, including fundoplication and endoscopic plication or TIF
• Prior gastric surgery, including weight reduction surgery
• Presence of oesophageal motility disorder (Eg. Achalasia) as measured by manometry
• Presence of a large hiatus hernia (greater than 2cm)
• Significant mental health issue or cognitive impairment affecting ability to provide informed consent
• Pregnant or breast feeding
• Significant coagulopathy or those who cannot safely interrupt the course of anticoagulation for few days for the RAP procedure.

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
Efficacy
Statistical methods / analysis
There is no pre-existing data to allow calculation of sample size from expected effect size. Whilst there is no set way to calculate appropriate number for pilot study, prior studies have used 10-35 participants. We will aim to recruit 10 patients based on expected number of patients who would be suitable for RAP procedure.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
2/02/2028
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26813 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 42864 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 316953 0
University
Name [1] 316953 0
Australian National University - Advanced Health Care Limited research grant
Country [1] 316953 0
Australia
Primary sponsor type
Individual
Name
Dr Calvin Park
Address
Country
Australia
Secondary sponsor category [1] 319237 0
None
Name [1] 319237 0
Address [1] 319237 0
Country [1] 319237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315709 0
Adventist HealthCare Ltd Human Research Ethics Committee
Ethics committee address [1] 315709 0
Ethics committee country [1] 315709 0
Australia
Date submitted for ethics approval [1] 315709 0
13/07/2024
Approval date [1] 315709 0
27/08/2024
Ethics approval number [1] 315709 0

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

Contacts
Principal investigator
Name 135558 0
Dr Calvin Park
Address 135558 0
Sydney Gastroenterology & Liver Group, Sydney Adventist Hospital Suite 213 'San Clinic Tulloch', 185 Fox Valley Road, Wahroonga, NSW, 2076
Country 135558 0
Australia
Phone 135558 0
+61 2 9480 6210
Fax 135558 0
Email 135558 0
[email protected]
Contact person for public queries
Name 135559 0
Calvin Park
Address 135559 0
Sydney Gastroenterology & Liver Group, Sydney Adventist Hospital Suite 213 'San Clinic Tulloch', 185 Fox Valley Road, Wahroonga, NSW, 2076
Country 135559 0
Australia
Phone 135559 0
+61 2 9480 6210
Fax 135559 0
Email 135559 0
[email protected]
Contact person for scientific queries
Name 135560 0
Calvin Park
Address 135560 0
Sydney Gastroenterology & Liver Group, Sydney Adventist Hospital Suite 213 'San Clinic Tulloch', 185 Fox Valley Road, Wahroonga, NSW, 2076
Country 135560 0
Australia
Phone 135560 0
+61 2 9480 6210
Fax 135560 0
Email 135560 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.