Role of ARMA in Selective Subset of Refractory GERD Patients.

Asian Institute of Gastroenterology, India50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

GERD Reflux Reflux Esophagitis

Interventions

ARMAPROCEDURE

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.

UGI EndoscopyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Asian institute of Gastroenterology, hyderabad, India

Hyderabad, Telangana, India

Outcomes

Primary Outcomes

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.

Time frame: One Year

Secondary Outcomes

Improvement in esophageal acid exposure

Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.

Time frame: One Year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.