Antireflux Ablation Therapy (ARAT) for Gastroesophageal Reflux Treatment
Mexico95 participantsStarted 2016-01-10
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of ARAT with Hybrid-APC in patients with GERD without hiatal hernia
Timeframe: One year
Trial details
NCT IDNCT03548298
SponsorCoordinación de Investigación en Salud, Mexico