Role of ARMA in Selective Subset of Refractory GERD Patients.

Asian Institute of Gastroenterology, India

Status: Completed

Conditions: Reflux Esophagitis; GERD; Reflux

Treatments: Procedure: ARMA; Procedure: UGI Endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05899491

ARMA

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

ARMA Group

Active Comparator group

Description:

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.

Treatment:

Procedure: ARMA

Sham Group

Sham Comparator group

Description:

UGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes.

Treatment:

Procedure: UGI Endoscopy