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

September 17, 2019 updated by: Coordinación de Investigación en Salud, Mexico

Antireflux Ablation Therapy (ARAT) With Hybrid-APC (Argon Plasma Coagulation) for GERD Treatment in Patients Without Hiatal Hernia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Ciudad de mexico, Mexico, 06720
        • Centro Medico Nacional Siglo XXI, Hospital de Especialidades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

September 10, 2019

Study Registration Dates

First Submitted

May 23, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2018-3601-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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