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

Esophageal Achalasia Clinical Trial

— IPPOEM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899842
• Other study ID #: AOIGCSMERRI/2020/LC-01
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: May 2026

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Antoine Debourdeau
• Phone: 06.68.31.94.89
• Email: a-debourdeau[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: May 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Achalasia
• Gastroesophageal Reflux

Intervention

Drug:
• Protein pump inhibitor therapy systematically
Lansoprazole 30mg once per day

Locations

Country	Name	City	State
France	AP-HM	Marseille
France	CHU de Montpellier	Montpellier
France	Clinique mutualiste Beausoleil	Montpellier
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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