Gastroesophageal Reflux Disease
Conditions
Keywords
Gastroesophageal Reflux Disease (GERD), ARAT, ARMS
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 an option of treatment in these patient but its associated with high morbidity, as well as a greater possibility of early therapeutic failure, for these reasons new therapies are in development being the mucosectomy with band and ablation of the esophagogastric junction with hybrid argon plasma options widely available that can offer 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. The aims of the study is to evaluate the safety and efficacy of this new techniques in the management or gastroesophageal reflux disease without hiatal hernia.
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 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.
Interventions
PROCEDUREAblation of the gastroesophageal junction with hybrid argon plasma
In the management group with argon plasma hybrid after marking 270 degrees of the esophagogastric junction, submucosal elevation and argon plasma burn of the marked and elevated area is performed.
PROCEDUREmucosectomy with band of the gastroesophageal junction
In the management group with mucosectomy after marking 270 degrees of the esophagogastric junction, a submucosal elevation of the marked area is performed to subsequently perform ligation and resection with a hot snare below the ligation area.
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
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 ARMS
Intervention 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 ARMS
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of management with ARAT and ARMS in reducing the total percent acid exposure time | 3, 6 and 12 months | the investigators will compare the percentage of improvement in esophageal Ph metry before and after procedure |
Countries
Mexico
Outcome results
None listed