Antireflux Ablation Therapy (ARAT) Vs Antireflux Mucosectomy (ARMS) In The Management Of Gastroesophageal Reflux Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastroesophageal Reflux Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A simple randomized, comparative (pretreatment and posttreatment), prospective clinical trial will be carried out among the group of patients managed with ARAT and ARMSMasking: Single (Investigator)Masking Description: The investigator in charge of capturing the data will only know if the patients received an A or B treatment without knowing the meaning of these letters; the endoscopist who carries out the procedure and the patient will be aware that group A corresponds to management with ARAT and group B to management with ARMSPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
Gastroesophageal reflux disease is a disease with high global prevalence, reaching rates of 19.6 and 40% in our country, for which it is one of the most common reasons for medical care and although a clinical response is obtained in an 80-90% of patients with the use of proton pump inhibitors, the r...
Gastroesophageal reflux disease is a disease with high global prevalence, reaching rates of 19.6 and 40% in our country, for which it is one of the most common reasons for medical care and although a clinical response is obtained in an 80-90% of patients with the use of proton pump inhibitors, the rest of the patients represents a medical challenge; surgical and endoscopic treatment being within the treatment options, the former having a high related morbidity (perforation, vagal nerve injury, postoperative dysphagia, etc), its duration is suboptimal and a second operation is associated with more surgical complications and morbidity, as well as a greater possibility of early therapeutic failure. For all these reasons, new endoluminal therapies have begun to be planned, including transoral fundoplication and radiofrequency ablation of the esophagogastric junction, these with controversial results and with the need of the use of special accessories and instruments that are not widely available; mucosectomy with band and ablation of the esophagogastric junction with hybrid argon plasma are widely available procedures in medical centers, offering a viable therapeutic option for patients with difficult control of symptoms or those who does not want to receive continuous medical treatment or surgical treatment.
Tracking Information
- NCT #
- NCT04036942
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Oscar V Hernandez Mondragon, MD Instituto Mexicano del Seguro Social
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