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ClinicalTrials.gov ID

NCT05899842

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

132Estimated

Last Update Posted

Feb 10, 2026Actual

Start Date

Jun 1, 2023Actual

Primary Completion Date

Feb 2028Estimated

Completion Date

Feb 2028Estimated

Official Title

Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia. Randomized Open-label Clinical Trial

Brief Summary

Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. There is no recommendation on the prescription of protein pump inhibitors (PPI) after the procedure and no study has studied the benefit of systematic prescription of PPI after POEM for achalasia. The study authors hypothesize that routine PPI prescribing post-POEM for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.

• Esophageal Achalasia

• Protein pump inhibitor therapy systematically

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

drc@chu-nimes.fr04.66.68.42.36