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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Esophageal Achalasia

Intervention / Treatment
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* Drug: Protein pump inhibitor therapy systematically


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systematic protein pump inhibitor therapy<br> | Drug: Protein pump inhibitor therapy systematically<br>* Lansoprazole 30mg once per day<br>|
| No Intervention: Protein pump inhibitor therapy as necessary<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Month 12 | 
| Patient quality of life between groups | WHOQOL-BREF questionnaire | Week 6 | 
| Patient quality of life between groups | WHOQOL-BREF questionnaire | Month 6 | 
| Patient quality of life between groups | WHOQOL-BREF questionnaire | Month 12 | 
| Patient health-related quality of life between groups | Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL) | Week 6 | 
| Patient health-related quality of life between groups | Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL) | Month 6 | 
| Patient health-related quality of life between groups | Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL) | Month 12 | 
| Quantity of PPI consumed between groups | Number of boxes of Lansoprazole consumed as recorded in PPI logbook | Month 3 | 
| Quantity of PPI consumed between groups | Number of boxes of Lansoprazole consumed as recorded in PPI logbook | Month 6 | 
| Quantity of PPI consumed between groups | Number of boxes of Lansoprazole consumed as recorded in PPI logbook | 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) | Month 12 | 
| Achalasia symptoms between groups | Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms)) | Week 6 | 
| Achalasia symptoms between groups | Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms)) | Month 6 | 
| Achalasia symptoms between groups | Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms)) | Month 12 | 
| Pyrosis symptoms between groups | Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal | Month 6 | 
| Pyrosis symptoms between groups | Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal | Month 12 |