ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

ARAT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gastroesophageal reflux disease

Condition category

Condition code

Oral and Gastrointestinal

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]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

To measure changes in PPI use baseline (pre-procedure), followed by 3 months and 12 months post-ARAT.

Secondary outcome [2]

To measure changes in GERDQ score

Timepoint [2]

To measure changes in GERDQ scores baseline (pre-procedure), followed by 3 months and 12 months post-ARAT.

Secondary outcome [3]

To measure changes in acid exposure time and DeMeester scores as a composite secondary outcome on 72-hour pH-monitoring.

Timepoint [3]

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]

To assess known intervention related adverse events such as dysphagia and stricture formation using the Dakkak and Bennett score.

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Chris O’Brien Lifehouse - Camperdown

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

ERBE Elektromedizin GmbH

Address [1]

25 International Business Park, #02-55/56 German Centre, Singapore 609916

Country [1]

Singapore

Primary sponsor type

Hospital

Name

Royal Prince Alfred Hospital

Address

50 Missenden road, Camperdown NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

50 Missenden Road, Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/11/2022

Approval date [1]

01/03/2023

Ethics approval number [1]

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

A/Prof Payal Saxena

Address

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

Australia

Phone

+61 407 436 653

Fax

[email protected]

Contact person for public queries

Name

Kevin Kyung Ho Choi

Address

Country

Australia

Phone

+61 401 945 726

Fax

[email protected]

Contact person for scientific queries

Name

Kevin Kyung Ho Choi

Address

Country

Australia

Phone

+61 401 945 726

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Our data will be used for our study only.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17522	Study protocol					384932-(Uploaded-29-04-2023-15-11-42)-Study-related document.docx
17523	Informed 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.

Trial Review

Documents added manually

Documents added automatically