Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000646943
Ethics application status
Approved
Date submitted
8/05/2020
Date registered
4/06/2020
Date last updated
21/01/2022
Date data sharing statement initially provided
4/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The RAP clinical trial: Safety of a novel endoscopic technique for post laparoscopic sleeve gastrectomy patients with severe reflux
Scientific title
Assessing the safety of a novel endoscopic resection and plication (RAP) technique in post laparoscopic sleeve gastrectomy patients with severe reflux: a pilot clinical trial
Secondary ID [1] 301236 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The RAP study
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal reflux 317398 0
Condition category
Condition code
Oral and Gastrointestinal 315501 315501 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
The "RAP" technique is a relatively novel endoscopic procedure conducted in bariatric patients who have undergone a laparoscopic gastric sleeve procedure and have severe reflux disease. It is conducted by senior gastroenterologists who have been credentialed in using the Overstitch device to conduct this procedure endoscopically. It is revisional surgery to anatomically improve the junction between the oesophagus and stomach to prevent stomach contents from refluxing into the oesophagus (as the anatomy has been surgically altered during the original laparoscopic sleeve gastrectomy, and patients are then prone to reflux symptoms). Some patients are managed effectively with medication but some do not respond to medication. The duration of the procedure is 45-60 minutes. Patients will stay overnight in hospital before being medically cleared for discharge the next day. The procedure involves the inside lining of the gastrointestinal tract is removed with the endoscope and then a suture is placed through the wall of the gastrointestinal tract to bunch up the muscle valve at the junction of the oesophagus and the stomach. The suture may stay in place permanently or may move over time. This then helps to prevent the contents of the stomach refluxing up into the oesophagus.
Intervention code [1] 317536 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323746 0
Measurement of adverse events to develop a safety profile, over 12 months
*Have you needed to see your local doctor or visited the hospital since you had the procedure / or since we last contacted you? Yes / No
If yes, details will be collected and adverse events will be categorised for reporting
Timepoint [1] 323746 0
Weekly for 6 weeks
At 3 months, 6 months, 9 months and 12 months
Secondary outcome [1] 382774 0
Determine the difference in Proton Pump Inhibitor use pre and post RAP procedure. The following questions will be asked at the time points below:
Are you currently taking a Proton Pump Inhibitor (PPI) drug? Yes / No
Which one? (Omeprazole (Losec), Esomeprazole (Nexium), Pantoprazole (Somac), Rabeprazole (Pariet) etc ):
Dose: _______________ How often? _________________
Do you take any other reflux medication? Yes / No
If Yes, please list the names here:
Timepoint [1] 382774 0
Baseline, 6 weeks, 3-months, 6-months, 9-months and 12-months
Secondary outcome [2] 382775 0
Determine the difference in the GERD-HRQL score, pre and post RAP procedure
Timepoint [2] 382775 0
Baseline, (Post procedure), 6- weeks, 3-months, 6-months, 9-months, 12-month
Secondary outcome [3] 382776 0
Determine the difference in the Reflux symptom score (pH Study), pre and post- RAP procedure
Timepoint [3] 382776 0
Baseline, 6-weeks, 3-months, 6-months, 9-months, 12-months
Secondary outcome [4] 382777 0
Determine the difference in the DeMeester score (pH study), pre and post RAP procedure
Timepoint [4] 382777 0
2-weeks pre RAP procedure and between 2-5 months post RAP procedure
Secondary outcome [5] 382778 0
Determine the difference in manometry readings pre and post RAP procedure
Timepoint [5] 382778 0
2- weeks pre RAP procedure and between 2-5 months post RAP procedure
Secondary outcome [6] 382779 0
Difference in body weight (Kg) pre and post RAP procedure
Timepoint [6] 382779 0
Baseline, 3-months, 6-months and 12-months
Secondary outcome [7] 382780 0
Measure change in Endoscopic endpoints: Hiatus hernia size. This is done during the endoscopic procedure and measured visually by the endoscopist. This is measured from the diagphragmatic pinch to the squamo-columar junction as reported in cm.
Timepoint [7] 382780 0
Baseline (RAP procedure) and 3-months post RAP procedure
Secondary outcome [8] 383228 0
Measure change in Endoscopic endpoint: Hiatal laxity. This is visual subjective measure and is classified by the endoscopist as present: Yes or No
Timepoint [8] 383228 0
Baseline (RAP procedure) and 3-months post RAP procedure
Secondary outcome [9] 383229 0
Measure change in Endoscopic endpoints: Hill grade measurement. This is a formal validated measure which grades the gastroesophageal junction and hiatal integrity. It is a subjective measure determined visually by the endoscopist. The grade can only be 1,2,3 or 4.
Timepoint [9] 383229 0
Baseline (RAP procedure) and 3-months post RAP procedure
Secondary outcome [10] 383230 0
Measure change in Endoscopic endpoint: Los Angeles (LA) Grade of oesophagitis. This measures the degree of oesophagitis present as A,B,C or D. It is a subjective measure determined visually by the endoscopist.
Timepoint [10] 383230 0
Baseline (RAP procedure) and 3-months post RAP procedure

Eligibility
Key inclusion criteria
• Age between 18 and 65 years.
• Typical symptoms of gastroesophageal disease that are refractory to medical therapy in patients (maximal therapy for 4 weeks)
1. That would like to avoid open/ laparoscopic surgery.
2. Who have undergone sleeve gastrectomy precluding them from open/laparoscopic anti reflux surgery
• Able to understand the procedure and follow up requirements.
• Voluntary agreement and signing of consent form.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of a hiatus hernia measuring equal to or greater than 3 centimetres on baseline endoscopy.
• Evidence of a primary oesophageal dysmotility.
• Anticoagulant or antiplatelet therapy, with the exception of Aspirin
• Pregnancy or intending to become pregnant in the 12 months after ESG
• Patients who lack capacity to provide written consent
• Allergy to medications used for anaesthetics
• Inability to return for scheduled clinic visits
• Advanced medical comorbidities defined as:
1) Decompensated cirrhosis
2) Cardiac failure with NYHA class III and IV symptoms
3) COPD – Stage III and IV
4) Kidney dysfunction on dialysis
5) Active cancer undergoing treatment
6) Cerebrovascular accident causing significant functional impairment
7) Severe nutritional deficiencies
8) Recent neoplasia (less than 5 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
The primary outcome measures are adverse events that have incurred related to the procedure up to 12-months. They will be classified as Serious Adverse Event (SAE) or Adverse Event’s (AE) and the sequelae and management of these will be captured and interpreted with simple descriptive statistics, to develop a safety profile of the RAP procedure in Australia.


Secondary outcome measures will include some functional measures to determine if the technique has merit for larger efficacy clinical trials. Due to this the following calculations have been done.
The sample size and power calculations are based a series of 7 patients (unpublished data) who have had the procedure performed at another hospital. This series showed an average reduction in the GERD HRQL score of 23.3 with a standard deviation of 9.1. Based on the mean of paired differences (reduction of 23.3) and standard deviation of these paired differences (9.1), We have calculated that a sample size of 4 patients will be enough to detect the mean difference of 23.3 with 91% power and 5% significance level, using a two-sided paired t test. If there were any dropouts expected, then the minimum sample size would increase to 5 patients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2020
Actual
28/04/2021
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
10
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16635 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 30230 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 305683 0
Commercial sector/Industry
Name [1] 305683 0
Apollo Endosurgery Australia Pty
Country [1] 305683 0
Australia
Funding source category [2] 305689 0
Other
Name [2] 305689 0
Obesity Surgery Brisbane
Country [2] 305689 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane Women's Hospital
Address
Department of Gastroenterology & Hepatology
Level 9, Ned Hanlon building
Butterfield Street, Herston, 4029
Country
Australia
Secondary sponsor category [1] 306100 0
None
Name [1] 306100 0
Address [1] 306100 0
Country [1] 306100 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305963 0
Royal Brisbane Women's Hospital
Ethics committee address [1] 305963 0
Royal Brisbane Women's Hospital, Human Research Ethics Committee
HREC office, Executive Suites
Lower Ground Floor, Dr James Mayne Building, RBWH
Butterfield Street, Herston, 4029
Ethics committee country [1] 305963 0
Australia
Date submitted for ethics approval [1] 305963 0
28/01/2020
Approval date [1] 305963 0
21/04/2020
Ethics approval number [1] 305963 0
HREC/2020/QRBW/61324

Summary
Brief summary
The primary purpose of the clinical trial is so establish a safety profile for the RAP (resection and plication) technique in patients who are experiencing severe reflux symptoms post laparoscopic sleeve gastrectomy. Endoscopic anti-reflux therapy is an emerging treatment considered for selected patients with gastro-oesophageal reflux disease that have a history of ongoing symptoms despite standard treatment. Additionally, the trial will measure quality of life measures, effects on reflux symptoms,endoscopic data points, medication usage and weight changes.
Trial website
None
Trial related presentations / publications
No publications to date on the trial have occurred
Public notes

Contacts
Principal investigator
Name 102230 0
Dr Patrick Walsh
Address 102230 0
Consultant Gastroenterologist
RBWH, Department of Gastroenterology & Hepatology
Level 9 Ned Hanlon Building,
Butterfield Street, Herston, 4029
Country 102230 0
Australia
Phone 102230 0
+61 411 706400
Fax 102230 0
Email 102230 0
[email protected]
Contact person for public queries
Name 102231 0
Ms Kimberley Ryan
Address 102231 0
Endoscopic Research Coordinator, RBWH
Dept of Gastroenterology & Hepatology
Level 9, Ned Hanlon Building
Butterfield Street, Herston, 4029
Country 102231 0
Australia
Phone 102231 0
+61 7 3646 5783
Fax 102231 0
Email 102231 0
[email protected]
Contact person for scientific queries
Name 102232 0
Dr Patrick Walsh
Address 102232 0
Consultant Gastroenterologist
RBWH, Department of Gastroenterology & Hepatology
Level 9 Ned Hanlon Building,
Butterfield Street, Herston, 4029
Country 102232 0
Australia
Phone 102232 0
+61 411 706400
Fax 102232 0
Email 102232 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
Ethical approval is based on the not sharing of any individual participant data so this will not be shared


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.