Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antireflux Ablation Therapy (ARAT) for Gastroesophageal Reflux Treatment (ARAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03548298
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Coordinación de Investigación en Salud, Mexico

Brief 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.

Condition or disease Intervention/treatment Phase
Gastro Esophageal Reflux Procedure: ARAT Not Applicable

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.


Layout table for study information
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)
Primary Purpose: Treatment
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 1, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GERD without hiatal hernia
Participants with GERD without hernia hiatal will receive ARAT
Procedure: 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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both sexes of age with a diagnosis of GERD and who are under medical treatment and who do not wish to undergo surgical treatment
  • Confirmed diagnosis of GERD in the following way:
  • Positive pHmetry
  • Positive endoscopy (GERD with esophagitis of any degree) or negative
  • Positive symptoms questionnaire for GERD
  • Manometry without evidence of esophageal motor disorder
  • Total or partial response to proton pump inhibitors

Exclusion Criteria:

  • Patients who do not accept the signature of the informed consent
  • Patients previously treated by surgery for GERD
  • Pregnant women.
  • Patients with hiatal hernia greater than 3 cm or Hill type IV
  • Patients with esophageal motility disorders
  • Patients in whom, for any reason, any antireflux surgery or endoscopic treatment has been contraindicated.
  • Patients who want to undergo surgical treatment as an initial option.
  • Patients with portal hypertension and the presence of esophageal varices
  • Patients with hemophilia or a haematological disorder that is difficult to control

Information from the National Library of Medicine

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


Locations
Layout table for location information
Mexico
Centro Medico Nacional Siglo XXI, Hospital de Especialidades
Ciudad de mexico, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Layout table for investigator information
Principal Investigator: Oscar V Hernández Mondragón, MD IMSS

Publications of Results:

Layout table for additonal information
Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03548298     History of Changes
Other Study ID Numbers: R-2018-3601-014
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Coordinación de Investigación en Salud, Mexico:
GERD, Hybrid-APC, efficacy, safety
ARAT

Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases