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

Coordinación de Investigación en Salud, Mexico

Status: Enrolling

Conditions: Gastroesophageal Reflux Disease

Treatments: Procedure: mucosectomy with band of the gastroesophageal junction; Procedure: Ablation of the gastroesophageal junction with hybrid argon plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04036942

R-2019-3601-179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups

Hybrid argon plasma.

Active Comparator group

Description:

After diagnostic endoscopy investigators will proceed to use argon plasma probe for marking 270 grades around the esophagogastric junction preserving part of the mucosa towards the greater curvature, then investigators will use the jet included in the argon plasma probe with effect 20 to 40 system for the injection of the background submucosa in the marking area, applying 0.9% saline solution with methylene blue, to achieve adequate Submucosal elevation for application or argon plasma with high voltages (100 watts, 1.5 liters / min) using forced coagulation mode, applying plasma argon to 1cm above the Z line in the esophageal mucosa and 2cm below it towards the gastric mucosa, argon will be applied until a "carbonization" effect of the mucosa is achieved, once the application of the therapy is performed mucosal lavage and immersion technique to corroborate integrity and continuity of the gastrointestinal tract and rule out immediate complications

Treatment:

Procedure: Ablation of the gastroesophageal junction with hybrid argon plasma

Band mucosectomy

Active Comparator group

Description:

After diagnostic endoscopy investigators will proceed to use the tip of a polypectomy snare for marking 270 grades around the esophagogastric junction preserving part of the mucosa towards the greater curvature, then investigators will perform submucosal elevation with the injection of 0.9% saline with carmine indigo and adrenaline 1:10000, after adequate submucosal elevation investigators will proceed with the help of a band ligation cap to suction and release the elastic band in the previously marked and elevated tissue, proceeding to resect the previously ligated tissue with polypectomy loop below the elastic band with forced coagulation (Effect 2, 40 W), until the marked mucosa is completely resected (average used of 5 elastic bands, reviewing the work area for complications like bleeding or perforation.

Treatment:

Procedure: mucosectomy with band of the gastroesophageal junction