IPPOEM: Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Systematic protein pump inhibitor therapy
|
Drug: Protein pump inhibitor therapy systematically
Lansoprazole 30mg once per day
|
| No Intervention: Protein pump inhibitor therapy as necessary
|
Outcome Measures
Primary Outcome Measures
- Presence of pathological acid reflux between groups [Month 6]
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
Secondary Outcome Measures
- Presence of pathological acid reflux between groups [Month 12]
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
- Patient quality of life between groups [Week 6]
WHOQOL-BREF questionnaire
- Patient quality of life between groups [Month 6]
WHOQOL-BREF questionnaire
- Patient quality of life between groups [Month 12]
WHOQOL-BREF questionnaire
- Patient health-related quality of life between groups [Week 6]
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
- Patient health-related quality of life between groups [Month 6]
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
- Patient health-related quality of life between groups [Month 12]
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
- Quantity of PPI consumed between groups [Month 3]
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
- Quantity of PPI consumed between groups [Month 6]
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
- Quantity of PPI consumed between groups [Month 12]
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
- Treatment tolerance between groups [Month 12]
Occurrence of adverse events as recorded by the doctor during patient interview using a scale of Grade 1 (minor) to Grade 5 (death)
- Achalasia symptoms between groups [Week 6]
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
- Achalasia symptoms between groups [Month 6]
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
- Achalasia symptoms between groups [Month 12]
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
- Pyrosis symptoms between groups [Month 6]
Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
- Pyrosis symptoms between groups [Month 12]
Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AP-HM | Marseille | France | ||
| 2 | CHU de Montpellier | Montpellier | France | ||
| 3 | Clinique mutualiste Beausoleil | Montpellier | France | ||
| 4 | CHU de Nîmes | Nîmes | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Antoine Debourdeau, CHU de Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AOIGCSMERRI/2020/LC-01