Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Jun 2, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the best way to prevent acid reflux after a specific treatment called Per Oral Endoscopic Myotomy (POEM) for a condition known as esophageal achalasia. The trial is comparing two approaches to using a medication called protein pump inhibitors (PPIs). One group will receive PPIs as a routine part of their care for a full year, while the other group will only get them if they have symptoms of reflux. Researchers believe that the routine use of PPIs might help reduce the occurrence of acid exposure in the esophagus after the procedure.

To be eligible for this trial, participants need to be adults aged 65 to 74 who have been diagnosed with achalasia and have a specific score indicating the severity of their condition. They must also be able to give their consent and be part of a health insurance plan. Those who have certain medical conditions or previous surgeries related to the esophagus, among other exclusions, will not be eligible. Participants can expect close monitoring and care throughout the study, helping researchers learn more about the best ways to manage acid reflux after POEM.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient with an indication for esophageal POEM for achalasia
• • Patient with all types of achalasia with Eckardt score \> 3
• • The patient must have given their free and informed consent and signed the consent form
• • The patient must be a member or beneficiary of a health insurance plan
• Exclusion Criteria:
• • Patient with contraindications to PPIs
• • Patient with mediastinal and esophageal neoplasia
• • Patient with a history of Heller myotomy surgery
• • Patients requiring any type of anti-reflux valve surgery
• • The subject is in a period of exclusion determined by a previous study
• • It is impossible to give the subject informed information
• • The patient is under safeguard of justice or state guardianship
• • Patient is pregnant, parturient or breastfeeding