Status:
WITHDRAWN
Antireflux Ablation Therapy (ARAT) Vs Antireflux Mucosectomy (ARMS) In The Management Of Gastroesophageal Reflux Disease
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Gastroesophageal reflux disease has a high global prevalence, proton pump inhibitors are the cornerstone in the management but 10-20% of the patients are refractory to these, surgical treatment being ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Patients of both sexes over 18 years and under 90 years with a diagnosis of GERD and who are under medical treatment and who do not want surgical treatment.
- Confirmed diagnosis of GERD as follows:
- Positive pHmetry. Positive endoscopy (Esophagitis grade C, D, stenosis or EB)
- Esophagogastric junction Hill I-III
- Total or partial response to proton pump inhibitors
- Patient who does not wish to take medication for the treatment of gastroesophageal reflux in the long term or indefinitely or refractory GERD
Exclusion
- Patients who do not accept the signature of the informed consent
- Postoperative fundoplication patients for GERD
- Patients with extraesophageal symptoms.
- Pregnant women.
- Patients with hiatal hernia larger than 3 cm or Hill type IV.
- Patients with major esophageal motility disorders.
- Patients with portal hypertension and presence of esophageal varices
- Patients with hemophilia or some haematological disorder that is difficult to control
- Patients with malignant pathology of the esophagus or Gastroesophageal Junction (GEJ).
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04036942
Start Date
July 15 2019
End Date
April 1 2025
Last Update
April 24 2025
Active Locations (1)
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1
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico City, Mexico, 06700