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

Not Applicable

• Conditions: Gastroesophageal Reflux; Achalasia
• Interventions: Procedure: ARAT technique

• Registration Number: NCT04065516
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-07-03
• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Argon Plasma Coagulation of the gastroesophageal junction	ARAT technique	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

Primary Outcome Measures

Name	Time	Method
A change in clinical symptoms of reflux disease assessed with a gastroesophageal reflux questionnaire after ARAT	measures will be performed at 3,6 and 12 months after ARAT	The clinical evaluation of reflux disease is going to be assessed by the use of a clinical gastroesophageal reflux disease questionnaire (GERD-Q) after ARAT. Reflux disease was considered positive when \>4 points is observed
A change in esophageal acid exposure assessed by pHmetry study after ARAT	measures will be performed at 3,6 and 12 months after ARAT	A 24-hours pHmetry study is going to be used to measure esophageal acid exposure in esophagus after ARAT. DeMeester Score and the percentage of esophagic acid exposure will be used to assess pathologic reflux (\>14.73 and \> 6%, respectively)
A change in erosive esophagitis grade assessed by upper endoscopy after ARAT	measures will be performed at 3,6 and 12 months after ARAT	Upper endoscopy is going to be used to measure the erosive esophagitis grade using the Los Angeles Esophagitis scale(grade A=mild, Grade B=moderate, Grade C=moderate high and Grade D=severe) after after ARAT

Trial Locations

Locations (1)

Centro Medico Nacional Siglo XXI Hospital de Especialidades; 🇲🇽 Mexico City, Mexico