Antireflux Ablation Therapy (ARAT) for Gastroesophageal Reflux Treatment (ARAT)
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|ClinicalTrials.gov Identifier: NCT03548298|
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastro Esophageal Reflux||Procedure: ARAT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|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)|
|Official Title:||Antireflux Ablation Therapy (ARAT) With Hybrid-APC (Argon Plasma Coagulation) for GERD Treatment in Patients Without Hiatal Hernia|
|Actual Study Start Date :||January 10, 2016|
|Actual Primary Completion Date :||July 1, 2019|
|Actual Study Completion Date :||September 10, 2019|
Experimental: GERD without hiatal hernia
Participants with GERD without hernia hiatal will receive ARAT
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.
- Efficacy of ARAT with Hybrid-APC in patients with GERD without hiatal hernia [ Time Frame: One year ]The efficacy of this treatment will be defined as: The decrease of ≥ 50 percent of the total percentage of acid exposure at 24 hrs (DeMeester Score)
- Safety of ARAT with hybrid-APC in patients with GERD without hiatal hernia [ Time Frame: One Year ]We will document any adverse event presented during or after application of ARAT therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548298
|Centro Medico Nacional Siglo XXI, Hospital de Especialidades|
|Ciudad de mexico, Mexico, 06720|
|Principal Investigator:||Oscar V Hernández Mondragón, MD||IMSS|