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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05899842
Other study ID # AOIGCSMERRI/2020/LC-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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