Antireflux Ablation Therapy (ARAT) for Gastroesophageal Reflux Treatment

NCT ID: NCT03548298

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-10
• Study Completion Date: 2019-09-10

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.

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.

Conditions

Gastro Esophageal Reflux

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GERD without hiatal hernia

Participants with GERD without hernia hiatal will receive ARAT

Group Type: EXPERIMENTAL

ARAT

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oscar V Hernández Mondragón, MD

Role: PRINCIPAL_INVESTIGATOR

IMSS

Locations

Centro Medico Nacional Siglo XXI, Hospital de Especialidades

Mexico City, , Mexico

Countries

Mexico

References

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Other Identifiers

R-2018-3601-014

Identifier Type: -

Identifier Source: org_study_id