ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
Condition: GERD
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment