ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)

Study Overview
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Brief Summary
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OBJECTIVES To study the safety and efficacy of Endoscopic Anti Reflux Mucosal Ablation (ARMA) procedure for the treatment of proton pump inhibitor (PPI) dependent gastro-esophageal reflux disease (GERD) DESIGN OF THE Prospective interventional study Sample size: 216

Detailed Description
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In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min. Submucosal injection and elevation will not be used as a part of ARMA procedure for 10 patients amended protocol version 2.0 Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire. Inclusion criteria Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI Patients who are willing to pay the expenses of the ARMA procedure Exclusion criteria Large Hiatal hernia >3cm Gr C/D esophagitis Lower esophageal sphincter (LES) pressure<5 or >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 Patients screening and inclusion: The study will be conducted over 6-months period. Data of patients presenting with PPI dependent GERD will be recorded and maintained. At initial screening, GERD HRQL and requirement of anti-secretory medicines (detailed drug history) will be assessed along with gastroscopy. All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs. Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines. Basal LES pressure, esophageal motility pattern, 24-h esophageal acid exposure, non acidic bolus reflux, number of reflux episodes, DeMeester score, symptom index and symptom association probability would be assessed.Those patients with pathologic esophageal acid exposure as described previously will be included in the trial. Patients will then be directly assigned by a computer to ARMA procedure. The principle investigator and the study coordinators would be open label to the treatment assignment.

Official Title
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ENDOSCOPIC ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) FOR THE TREATMENT OF PROTON PUMP INHIBITOR DEPENDENT GASTRO ESOPHAGEALREFLUX DISEASE: OPEN LABEL SINGLE CENTER OBSERVATIONAL STUDY

Conditions
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GERD

Intervention / Treatment
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* Procedure: ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI Patients who are willing to pay the expenses of the ARMA procedure Exclusion Criteria: • Large Hiatal hernia >3cm Gr C/D esophagitis Lower esophageal sphincter (LES) pressure<5 or >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: 18 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANTI REFLUX MUCOSAL ABLATION THERAPHY<br>In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min. | Procedure: ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)<br>* In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min. 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| requirement of PPI at 3, 6 and 12 months | requirement of Proton Pump Inhibitors at 3, 6 and 12 months based on GERD score evaluated based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE | requirement of PPI at 3, 6 and 12 months | 
| Improvement in esophageal acid exposure | Improvement in esophageal acid exposure in PH impedence monitoring report from baseline | 6 months | 
| Improvement in lower esophageal sphincter pressure at 3 months | Improvement in lower esophageal sphincter pressure at 3 months i.e sphincter pressure will be less compare to baseline pressure which will be known by the Esophageal manometry report. | 12 months |