Role of ARMA in Selective Subset of Refractory GERD Patients.

Not Applicable

Completed

• Conditions: Reflux Esophagitis; GERD; Reflux
• Interventions: Procedure: ARMA; Procedure: UGI Endoscopy

• Registration Number: NCT05899491
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

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

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 Timeline

• Study Start: 2023-03-30
• Study First Submitted: 2023-04-01
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-12
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ARMA Group	ARMA	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.
Sham Group	UGI Endoscopy	UGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes.

Primary Outcome Measures

Name	Time	Method
Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months.	One Year	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in esophageal acid exposure	One Year	Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.

Trial Locations

Locations (1)

Asian institute of Gastroenterology, hyderabad, India; 🇮🇳 Hyderabad, Telangana, India