None listed
Conditions
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.
Interventions
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.
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.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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
Outcome results
None listed