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

Condition(s) studied

Investigational drug(s) / intervention(s)

ARAT technique: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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
• 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 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

Trial sites (1)

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