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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
AP-HM
RECRUITING
Marseille
CHU de Montpellier
RECRUITING
Montpellier
Clinique mutualiste Beausoleil
RECRUITING
Montpellier
CHU de Nîmes
RECRUITING
Nîmes
Contact Information
Primary
Antoine Debourdeau
a-debourdeau@chu-montpellier.fr
06.68.31.94.89
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-05
Participants
Target number of participants: 132
Treatments
Experimental: Systematic protein pump inhibitor therapy
No_intervention: Protein pump inhibitor therapy as necessary
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes

This content was sourced from clinicaltrials.gov