WithdrawnNot Applicable

Antireflux Ablation Therapy (ARAT) Vs Antireflux Mucosectomy (ARMS) In The Management Of Gastroesophageal Reflux Disease

Stopped: problems with participants enrollment

Mexico0Started 2019-07-15

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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 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).

What they're measuring

efficacy of management with ARAT and ARMS in reducing the total percent acid exposure time

Timeframe: 3, 6 and 12 months

Trial details

NCT IDNCT04036942

SponsorCoordinación de Investigación en Salud, Mexico

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-04-01