ARMA for Postoperative GERD After Sleeve Gastrectomy

Study Overview
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Brief Summary
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This study is a pilot trial designed to evaluate the safety and efficacy of endoscopic anti-reflux ablation in postoperative gastroesophageal reflux after sleeve gastrectomy

Official Title
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Anti-reflux Mucosal Ablation (ARMA) for the Treatment of Postoperative Gastroesophageal Reflux After Sleeve Gastrectomy - A Pilot Study

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Procedure: Anti-reflux mucosal ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with reflux symptoms after sleeve gastrectomy and are dependent on or refractory to PPI treatment Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% on pH study Exclusion Criteria: Primary esophageal motility disorders Sliding hiatal hernia >3cm Narrow gastric sleeve that precludes retroflexion of scope Gastric sleeve stricture Malignancy Pregnancy Patients not fit for general anesthesia Other cases deemed by the examining physician as unsuitable for safe treatment Refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-reflux mucosal ablation<br>This technique creates an anti-reflux mechanism by performing mucosal ablation at the gastric cardia and inducing cicatrisation, and thereby rebuilds the flap valve at the gastric cardia | Procedure: Anti-reflux mucosal ablation<br>* Mucosal ablation is planned around the cardia on the gastric side in a butterfly shape. Submucosal layer is raised by injecting saline with indigo carmine dye. Mucosal ablation is performed using the triangle-tip knife in spray coagulation mode.<br>* Other names: ARMA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GERD symptoms | Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score [0-75, higher scores mean worse outcome] | 3 and 6months | 
| Change in GERD symptoms | astroesophageal Reflux Disease Questionnaire (GERDQ) score [0-18, higher scores mean worse outcome] | 3 and 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | defined as successful completion of endoscopic procedure | 1 day | 
| Change in DeMeester score and AET | evaluated by 24-hour pH monitoring | 3 months | 
| Dysphagia symptoms | evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score [0-40, higher score mean worse outcome] | 3 and 6 months | 
| PPI use | dosage of PPI use after procedure | 3 and 6 months | 
| Changes in cardia morphology | endoscopic assessment of Hill's flap grade | 3 months | 
| Adverse events rate relating to endoscopic intervention | complication including bleeding, perforation and stricture | 7 days, 1, 3 and 6 months |