Antireflux Ablation Therapy (ARAT) for Gastroesophageal Reflux Treatment
Condition: Gastro Esophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      Gastroesophageal Reflux Disease (GERD) is defined as the rise of gastric or gastroduodenal
      contents above the esophagogastric junction (EGJ), generating symptoms and/or esophageal
      lesions. It is estimated a failure to treatment with PPI(proton pump inhibitor) between
      10%-40% of patients with GERD. The main disadvantages of surgical treatment include
      perforation (0-4%), bleeding (<1%) and pneumothorax (0-10%), the most common late
      complication is gastric fullness, which occurs in almost all patients, approximately 25% of
      patients may experience persistent dysphagia 3 months after surgery and the most worrisome
      late complication is the need of a new surgical intervention. The aims of treatment at EGJ is
      to reduce gastroesophageal reflux contents into the esophagus. Hybrid-APC with ablation of
      EGJ (ARAT) is a new technique with could generate a scar remodeling this region and
      consequently reducing reflux disease. Our objective is to evaluate the safety and efficacy of
      ARAT in a group of patients with GERD without hiatal hernia.
    

Detailed description: 
      Gastroesophageal reflux disease is a condition in which there is a rise of gastroduodenal
      contents into the esophageal lumen, causing mucosal damage. Among treatments, medications are
      the most common used ones but up to 10%-40% doesn't respond to this type of treatment.
      Surgical treatment has been considered as the gold standard; however, with complications such
      as bleeding, perforation, or dysphagia after surgery. Moreover, not all patients are
      candidates to receive this type of treatment. Based on these data, new techniques have been
      explored in order to reduce morbidity, mortality and costs in the treatment of these
      patients.

      Among different endoscopical treatments, ablation of EGJ is a new promising technique which
      can be used to perform a closure at this level throughout the scar secondary to hybrid-APC
      treatment, consequently decreasing gastroesophageal reflux. So, the aim of this study is to
      evaluate safety and efficacy of ARAT in a group of patients with confirmed GERD.

      This is a quasi experimental study that will be conducted in a tertiary care center in Mexico
      city, Mexico. In an endoscopy department at the Mexican Institute of Social Security between
      January 2018 and July 2019. Those patients diagnosed with gastroesophageal reflux who are
      candidates and who accept this type of treatment will be evaluated. Patients who meet the
      inclusion criteria will be the definitive candidates. The risks and benefits of this type of
      endoscopic treatment will be explained as well as the potential scope of this endoscopic
      alternative. We will evaluate safety and efficacy of this new procedure.

      The technique of the procedure involves ablation of the mucosa of the EGJ using Hybrid-APC
      (ARAT). The ablation field is initially marked with a Hybrid-APC. 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. The approximate duration
      of the procedure is 40min.

      Follow-up will include objective evaluation of reflux disease with: upper endoscopy,
      manometry, pHmetry, reflux questionnaire, and need of PPI (proton-pump inhibitor) dose
      quantification.
    

Intervention name(s): ARAT
Intervention type(s): Procedure
Intervention description(s): After confirmation of GERD, participants will undergo to ablation with Hybrid-APC (ARAT). Participant will be admitted to hospital 24 hrs before procedure. Technique consist in ablation with hybrid-APC, submucosal injection of saline solution with methylene blue at 3-4 cm from 60-70% cardias and 1 cm esophageal. After procedure they will be kept on surveillance and will be followed-up with clinical, endoscopic, esophageal manometry and pHmetry up to 1 year after procedure.
Intervention model: Single Group Assignment
Intervention model description: Men and women with diagnosis of GERD confirmed by endoscopy or pHmetry, GERD questionnaire and that accept this new treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GERD, Hybrid-APC, efficacy, safety; ARAT