Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000462684
Ethics application status
Approved
Date submitted
2/11/2022
Date registered
4/05/2023
Date last updated
4/05/2023
Date data sharing statement initially provided
4/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Endoscopic anti-reflux treatment for those with reflux disease after gastric sleeve surgery
Scientific title
Safety, Feasibility and Efficacy of Anti-Reflux Ablative Therapy (ARAT) in Patients with Gastroesophageal reflux disease (GERD) after Gastric Sleeve Surgery: A Prospective Cohort
Secondary ID [1] 308333 0
None
Universal Trial Number (UTN)
Trial acronym
ARAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal reflux disease 328122 0
Condition category
Condition code
Oral and Gastrointestinal 325177 325177 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
Anti-reflux ablative therapy (ARAT)
An endoscope with 9.8mm outer diameter and a 2.8mm working channel will be used (Olympus). An electrosurgical unit (ERBE VIO-200D, Tübingen, Germany), ErbeJet2 module (ERBE), and an hybrid argon plasma coagulation (H-APC) Catheter (ERBE) will be used along with a mixture of 0.9% saline solution and 0.5% methylene blue. All procedures will be performed with the patient in the left lateral position under deep sedation with Propofol, (+/- midazolam) and fentanyl. Hybrid argon plasma coagulation (APC) will be performed in a retroflexion view within the esophagus. The steps of the procedure will be the following:
1. Endoscopic evaluation: The gastroesophageal junction (GEJ) is reviewed and cleaned as necessary in retroflexion view
2. Marking: 2 marking line composed of 5 – 6 dots below the gastroesophageal junction (GEJ) towards the fundus, using soft coagulation (effect 2, 30 W) with 1.5 - 2.0cm in between the two lines. The distance between the two lines corresponds to the ablation free zone.
3. Elevation: Submucosal bleb will be created with injection of a mixed solution of saline and methylene blue all along the gastroesophageal junction (GEJ) in retroflexion. The pressure level of injection will be set at 60 with a total amount of fluid used set at 20mls.
4. Ablation: High-power coagulation (Forced coagulation effect 3, 100W) will be applied along the gastroesophageal junction (GEJ) starting at the z-line down to 3cm below this point in a circumferential manner ablating 270 – 320 degrees of mucosa.

The procedure will be performed by an experienced gastroenterologist who has specialised in therapeutic endoscopy. The duration of the procedure will be approximately 1 hour. The procedure will be performed once only. All procedures will be recorded by video to ensure fidelity of the intervention.
Intervention code [1] 324782 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333005 0
To measure the proportion of patients who cease of proton pump inhibitors (PPI) use after Anti-Reflux Ablative Therapy (ARAT) in patients after laparoscopic sleeve gastrectomy. This will be measured by a 2 week PPI use diary before the procedure, at 3 months and at 12 months.
Timepoint [1] 333005 0
Proportion of patients who have ceased PPI after ARAT at 3 months.
Proportion of patients who have ceased PPI after ARAT at 12 months.
Secondary outcome [1] 415514 0
To measure changes in PPI use pre- and post-procedure. Usage will be classified as twice dose daily, single dose daily, intermittent use, and cessation of use, in order to determine percentage change in PPI use. PPI use will be determined using a study-specific questionnaire provided to participants regarding use patterns over the prior 14 days.
Timepoint [1] 415514 0
To measure changes in PPI use baseline (pre-procedure), followed by 3 months and 12 months post-ARAT.
Secondary outcome [2] 415516 0
To measure changes in GERDQ score
Timepoint [2] 415516 0
To measure changes in GERDQ scores baseline (pre-procedure), followed by 3 months and 12 months post-ARAT.
Secondary outcome [3] 415518 0
To measure changes in acid exposure time and DeMeester scores as a composite secondary outcome on 72-hour pH-monitoring.
Timepoint [3] 415518 0
To measure changes in acid exposure time and DeMeester scores as a composite secondary outcome on 72-hour pH-monitoring at baseline (pre-procedure), followed by 3 months and 12 months post-ARAT.
Secondary outcome [4] 415520 0
To assess known intervention related adverse events such as dysphagia and stricture formation using the Dakkak and Bennett score.
Timepoint [4] 415520 0
To assess known intervention related adverse events such as dysphagia and stricture formation using the Dakkak and Bennett score at 3 months and 12 months post-ARAT.

Eligibility
Key inclusion criteria
Indications confirmed via screening:
1. Persisting reflux symptoms if weaning from medication (PPI dependence)
2. Unacceptable life-long medication use
3. Intolerance to PPI due to medication related side effects
4. DeMeester score >14.72 or acid exposure to >6% (from 24 hour pH monitoring)
5. LA Grade A esophagitis or more (from previous gastroscopy)

Inclusion Criteria
1. Indication #1 and at least one other indication
2. Equal to or above 18 years of age or below 85 years of age
3. Patients who have undergone vertical sleeve gastrectomy
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Conditions of primary esophageal dysmotility (i.e Achalasia, Distal esophageal spasm, etc)
2. Conditions causing secondary esophageal disorders (i.e systemic sclerosis, dermatomyositis)
3. Peptic stricture
4. Malignancy of the esophagus
5. Barrett’s esophagus with dysplasia
6. Hill Grade 4
7. Eosinophilic Esophagitis at screening endoscopy
8. Previous gastro-esophageal surgery including surgical fundoplication procedures
9. Portal hypertension and esophageal varices
10. Significant comorbidities (Charleson index score >5 or ASA >2)
11. Coagulation disorders
12. Pregnancy

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
20 patients will be recruited for this trial. This study will be the world's first prospective safety and efficacy trial of ARAT in participants with laparoscopic sleeve gastrectomy.
Data will be analysed descriptively. Baseline characteristics of the patient population, BE characteristics, technical details, and procedure outcomes will be summarised as a mean (SD) or median (with interquartile range [IQR] and range) for continuous data, and as frequencies and proportions for categorical data. All statistical analysis will be performed using SAS 9.4 (SAS Institute Inc., Cary, NC).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
6/07/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23493 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 23494 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 38900 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 312578 0
Commercial sector/Industry
Name [1] 312578 0
ERBE Elektromedizin GmbH
Country [1] 312578 0
Singapore
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
50 Missenden road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 314186 0
None
Name [1] 314186 0
Address [1] 314186 0
Country [1] 314186 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311904 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 311904 0
50 Missenden Road, Camperdown NSW 2050
Ethics committee country [1] 311904 0
Australia
Date submitted for ethics approval [1] 311904 0
02/11/2022
Approval date [1] 311904 0
01/03/2023
Ethics approval number [1] 311904 0
X22-0380 & 2022/ETH01208

Summary
Brief summary
Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disease. It is a common occurrence after laparoscopic sleeve gastrectomy (LSG) with prevalence of de novo reflux ranging between 9.8 – 30%. GERD after LSG should be considered a serious adverse outcome due to worsening quality of life and increased incidence of Barrett’s esophagus after surgery. Surgical intervention with fundoplication is the usual treatment in those with GERD. However, it is not technically feasible in those who have undergone LSG. Other endoscopic treatments and devices exist however they are technically challenging and difficult to use. Recently, Anti-reflux therapy (ARAT) using Hybrid APC is an efficient and simple way to treat reflux. The first application of Hybrid APC as an anti-reflux procedure in endoscopy was reported in a retrospective study by showing cessation of PPI use of 78.6% at 36 months in a non-bariatric population. Therefore, the aim of this study is to assess the safety, feasibility, and efficacy of ARAT by measuring the reduction in PPI use in patients after LSG.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122786 0
A/Prof Payal Saxena
Address 122786 0
Advanced Endoscopy & Gastroenterology
Suite G10, 100 Carillon Avenue, Newtown 2042

Royal Prince Alfred Hospital
50 Missenden Road, Camperdown 2050

Chris O'Brien lifehouse
Missenden Road, Camperdown 2050
Country 122786 0
Australia
Phone 122786 0
+61 407 436 653
Fax 122786 0
Email 122786 0
payal.saxena@sydney.edu.au
Contact person for public queries
Name 122787 0
Dr Kevin Kyung Ho Choi
Address 122787 0
Advanced Endoscopy & Gastroenterology
Suite G10, 100 Carillon Avenue, Newtown 2042

Royal Prince Alfred Hospital
50 Missenden Road, Camperdown 2050

Chris O'Brien lifehouse
Missenden Road, Camperdown 2050
Country 122787 0
Australia
Phone 122787 0
+61 401 945 726
Fax 122787 0
Email 122787 0
kevin.kh.choi@gmail.com
Contact person for scientific queries
Name 122788 0
Dr Kevin Kyung Ho Choi
Address 122788 0
Advanced Endoscopy & Gastroenterology
Suite G10, 100 Carillon Avenue, Newtown 2042

Royal Prince Alfred Hospital
50 Missenden Road, Camperdown 2050

Chris O'Brien lifehouse
Missenden Road, Camperdown 2050
Country 122788 0
Australia
Phone 122788 0
+61 401 945 726
Fax 122788 0
Email 122788 0
kevin.kh.choi@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our data will be used for our study only.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17522Study protocol    384932-(Uploaded-29-04-2023-15-11-42)-Study-related document.docx
17523Informed consent form    384932-(Uploaded-29-04-2023-15-15-27)-Study-related document.doc



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.