ARAT for Reflux Disease After Peroral Endoscopic Myotomy in Patients With Achalasia

Coordinación de Investigación en Salud, Mexico

Status: Invitation-only

Conditions: Achalasia; Gastroesophageal Reflux

Treatments: Procedure: ARAT technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04065516

R-2019-3601-135

Details and patient eligibility

About

The peroral endoscopic myotomy for the treatment of achalasia is associated with a higher incidence of gastroesophageal reflux disease compared with Heller's myotomy. Remodeling of the esophagogastric junction with hybrid argon plasma could decrease the passage of gastric or gastroduodenal content into the esophagus.

Full description

Achalasia is the inability of the lower esophageal sphincter to relax in the context of dysfunction of esophageal peristalsis. Peroral endoscopic myotomy for the treatment of achalasia has an efficacy above 90%, being comparable with Heller's myotomy. The treatment of achalasia by peroral endoscopic myotomy is associated with a higher incidence of gastroesophageal reflux disease, compared with alternative therapies such as Heller's myotomy or pneumatic dilatation. Hybrid argon plasma at the level of the esophagogastric junction could generate remodeling of this region generating a partial stenosis and thereby decrease the passage of gastric or gastroduodenal content into the esophagus.

A clinical trial will be carried out, including all patients with achalasia, treated by peroral myotomy older than 18 years old, with abnormal acid exposure in the pHmetry test 3 months or more after treatment, who accept the management of ablation with hybrid argon plasma. To whom the ablation will be performed with Hybrid Argon Plasma and its effectiveness will be evaluated by clinical questionnaires, endoscopy and pHmetry measurement at the beginning, 3 months, 6 months and 12 months after the procedure.

Demographic and clinical data will be recorded in a data collection sheet, detailing the reflux questionnaire(GERDQ), Eckardt score, endoscopic findings of esophagitis according to Los Angeles classification and abnormal acid exposure in each evaluation. The data will be condensed into a database for subsequent statistical analysis and publication of results.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Achalasia type I, II, III
• Treatment with POEM (Peroral Endoscopic Myotomy)
• Abnormal acid exposure (>6%) in the 24h-pHmetry test more than three months after the procedure
• Signed informed consent

Exclusion criteria

• Patients who do not accept the treatment
• Previous antireflux surgery
• Previous Heller's Myotomy
• Hiatal hernia greater than 3 centimeters
• Hill's Classification Grade IV
• Pregnancy
• Patients with any contraindication for an endoscopy
• Patients with esophageal or gastric varices

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Argon Plasma Coagulation of the gastroesophageal junction

Experimental group

Description:

Participants with abnormal acid exposure after peroral endoscopic myotomy for achalasia, will be treated by ablation of the gastroesophageal junction with hybrid argon plasma coagulation

Treatment:

Procedure: ARAT technique