Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia (IPPOEM)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05899842 |
Recruitment Status :
Recruiting
First Posted : June 12, 2023
Last Update Posted : June 12, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Achalasia | Drug: Protein pump inhibitor therapy systematically | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 132 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 1, 2023 |
Estimated Primary Completion Date : | January 2026 |
Estimated Study Completion Date : | May 2026 |
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 |
- Presence of pathological acid reflux between groups [ Time Frame: 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
- Presence of pathological acid reflux between groups [ Time Frame: 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 [ Time Frame: Week 6 ]WHOQOL-BREF questionnaire
- Patient quality of life between groups [ Time Frame: Month 6 ]WHOQOL-BREF questionnaire
- Patient quality of life between groups [ Time Frame: Month 12 ]WHOQOL-BREF questionnaire
- Patient health-related quality of life between groups [ Time Frame: Week 6 ]Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
- Patient health-related quality of life between groups [ Time Frame: Month 6 ]Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
- Patient health-related quality of life between groups [ Time Frame: Month 12 ]Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
- Quantity of PPI consumed between groups [ Time Frame: Month 3 ]Number of boxes of Lansoprazole consumed as recorded in PPI logbook
- Quantity of PPI consumed between groups [ Time Frame: Month 6 ]Number of boxes of Lansoprazole consumed as recorded in PPI logbook
- Quantity of PPI consumed between groups [ Time Frame: Month 12 ]Number of boxes of Lansoprazole consumed as recorded in PPI logbook
- Treatment tolerance between groups [ Time Frame: 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 [ Time Frame: Week 6 ]Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
- Achalasia symptoms between groups [ Time Frame: Month 6 ]Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
- Achalasia symptoms between groups [ Time Frame: Month 12 ]Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
- Pyrosis symptoms between groups [ Time Frame: Month 6 ]Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
- Pyrosis symptoms between groups [ Time Frame: Month 12 ]Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05899842
Contact: Antoine Debourdeau | 06.68.31.94.89 | a-debourdeau@chu-montpellier.fr |
France | |
AP-HM | Recruiting |
Marseille, France | |
Contact: Jean Michel Gonzalez 06.22.25.02.50 jean-michel.gonzalez@ap-hm.fr | |
Principal Investigator: ean Michel Gonzalez | |
CHU de Montpellier | Recruiting |
Montpellier, France | |
Contact: Antoine Debourdeau 06.68.31.94.89 antoinedebourdeau@hotmail.com | |
Principal Investigator: Antoine Debourdeau | |
Clinique mutualiste Beausoleil | Recruiting |
Montpellier, France | |
Contact: Roman Combes 06.76.59.23.48 roman.combes@hotmail.fr | |
Principal Investigator: Roman Combes | |
CHU de Nîmes | Recruiting |
Nîmes, France | |
Contact: Anissa Megzari 04.66.68.42.36 drc@chu-nimes.fr | |
Principal Investigator: Ludovic Caillo |
Principal Investigator: | Antoine Debourdeau | CHU de Nimes |
Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
ClinicalTrials.gov Identifier: | NCT05899842 |
Other Study ID Numbers: |
AOIGCSMERRI/2020/LC-01 |
First Posted: | June 12, 2023 Key Record Dates |
Last Update Posted: | June 12, 2023 |
Last Verified: | June 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gastroesophageal Reflux Esophageal Achalasia Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |