Role of ARMA in Selective Subset of Refractory GERD Patients.

Study Overview
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Brief Summary
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To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).

Detailed Description
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Patients coming with symptoms of Gastroesophageal reflux disease (GERD) - A digestive disease in which stomach acid or bile irritates the food pipe lining, will be screened for eligibility and informed written consent will be taken. At initial screening, score based on clinical symptoms i.e. Gastroesophageal Reflux Disease- Quality of Life score (GERD HRQL) & Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease Questionnaire (FSSG) score will be completed. All patients will undergo esophagogastroscopy (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract). to look for reflux (the backward flow of stomach acid into the tube that connects your throat to your stomach (esophagus)) related changes in the esophagus. Esophageal high-resolution Manometry (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done to measure the various parameters which help doctor understand your disease. 24-hr pH impedance (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done after stopping anti-secretory medicines (medicines for the long-term treatment of GERD) for atleast three days to assess for esophageal parameters. All patients will be divided randomly into two arms, ARMA and sham. Those in the ARMA arm will receive ARMA procedure, while patients in the sham arm will receive only upper gastrointestinal endoscopy.

Official Title
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Role of ARMA in Selective Subset of Refractory GERD Patients- A Randomized Sham Control Trial.

Conditions
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GERD, Reflux, Reflux Esophagitis

Intervention / Treatment
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* Procedure: ARMA
* Procedure: UGI Endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal Upper Gastrointestinal endoscopy And 24 hour pH Impedance: AET < 6%, More than 80 refluxes Patients who are willing to give consent for the procedure Exclusion Criteria: Large Hiatal hernia >3cm Lower esophageal sphincter (LES) pressure >15 mm Hg Paraesophageal hernia GE flap valve grade IV (Hill's classification) Barretts esophagus Esophageal dysmotility ASA physical status >II Previous esophageal or gastric surgery Pregnancy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A Randomized Sham Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARMA Group<br>All patients in this group will undergo Anti-reflux mucosal ablation using upper gastrointestinal endoscopy. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view. | Procedure: ARMA<br>* Patients will be instructed to fast for 6 hours pre-ARMA, the Procedure will be performed under propofol-based sedation. Patients will be in the left lateral decubitus position. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view.<br>|
| Sham Comparator: Sham Group<br>UGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes. | Procedure: UGI Endoscopy<br>* UGI Endoscopy will be performed under propofol based sedation with scope kept inside for atleast 5 minutes. Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry, reflux questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months. | Improvement in Gastroesophageal reflux disease symptoms by more than 50% from baseline at 3 months which would be assessed based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE. | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in esophageal acid exposure | Improvement in esophageal acid exposure in PH impedence monitoring report from baseline. | One Year |