Endoscopic anti-reflux treatment for those with reflux disease after gastric sleeve surgery

Not Applicable

• Conditions: Gastroesophageal reflux disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12623000462684
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-04
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. [Proportion of patients who have ceased PPI after ARAT at 3 months.<br>Proportion of patients who have ceased PPI after ARAT at 12 months.]