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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
132
Lansoprazole 30mg once per day
AP-HM
Marseille, France
RECRUITINGCHU de Montpellier
Montpellier, France
RECRUITINGClinique mutualiste Beausoleil
Montpellier, France
RECRUITINGCHU de Nîmes
Nîmes, France
RECRUITINGPresence of pathological acid reflux between groups
According to the Lyon 2018 criteria: Esophagitis grade C or D according to the Los Angeles classification and/or acid exposure \>6% on 24-hour esophageal pH-metry
Time frame: Month 6
Presence of pathological acid reflux between groups
According to the Lyon 2018 criteria: Esophagitis grade C or D according to the Los Angeles classification and/or acid exposure \>6% on 24-hour esophageal pH-metry
Time frame: Month 12
Patient quality of life between groups
WHOQOL-BREF questionnaire
Time frame: Week 6
Patient quality of life between groups
WHOQOL-BREF questionnaire
Time frame: Month 6
Patient quality of life between groups
WHOQOL-BREF questionnaire
Time frame: Month 12
Patient health-related quality of life between groups
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Time frame: Week 6
Patient health-related quality of life between groups
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Time frame: Month 6
Patient health-related quality of life between groups
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Time frame: Month 12
Quantity of PPI consumed between groups
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Time frame: Month 3
Quantity of PPI consumed between groups
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Time frame: Month 6
Quantity of PPI consumed between groups
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Time frame: Month 12
Treatment tolerance between groups
Occurrence of adverse events as recorded by the doctor during patient interview using a scale of Grade 1 (minor) to Grade 5 (death)
Time frame: Month 12
Achalasia symptoms between groups
Measured as Eckardt score \>3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Time frame: Week 6
Achalasia symptoms between groups
Measured as Eckardt score \>3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Time frame: Month 6
Achalasia symptoms between groups
Measured as Eckardt score \>3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Time frame: Month 12
Pyrosis symptoms between groups
Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
Time frame: Month 6
Pyrosis symptoms between groups
Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
Time frame: Month 12
Patient quality of life between groups
WHOQOL-BREF questionnaire
Time frame: Inclusion
Patient health-related quality of life between groups
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Time frame: Inclusion
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