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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Antireflux Ablation Therapy (ARAT) at Esophagogastric Junction in Patients With Reflux Disease After Peroral Endoscopic Myotomy (POEM) in Achalasia

Conditions
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Achalasia, Gastroesophageal Reflux

Intervention / Treatment
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* Procedure: ARAT technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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 pH measurement at the beginning, 2 months, 6 months and 12 months after the procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Argon Plasma Coagulation of the gastroesophageal junction<br>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 | Procedure: ARAT technique<br>* After an initial endoscopic evaluation, ARAT technique will be performed with marking, submucosal elevation at esophagogastric junction and then ablation with 100-120w of 270-300 degrees at esophagogastric junction, once the application of the therapy is performed mucosal lavage and immersion technique will be made to corroborate integrity and continuity of the gastrointestinal tract and rule out immediate complications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in erosive esophagitis grade assessed by upper endoscopy 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 | measures will be performed at 3,6 and 12 months after ARAT | 
| A change in esophageal acid exposure assessed by pHmetry study 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) | measures will be performed at 3,6 and 12 months after ARAT | 
| A change in clinical symptoms of reflux disease assessed with a gastroesophageal reflux questionnaire 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 | measures will be performed at 3,6 and 12 months after ARAT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achalasia, Gastroesophageal Reflux, Argon Plasma Coagulation, Peroral Endoscopic Myotomy