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

Primary Purpose

Esophageal Achalasia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Protein pump inhibitor therapy systematically
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Achalasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AP-HMRecruiting
  • CHU de MontpellierRecruiting
  • Clinique mutualiste BeausoleilRecruiting
  • CHU de NîmesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Systematic protein pump inhibitor therapy

Protein pump inhibitor therapy as necessary

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2023
Last Updated
June 2, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT05899842
Brief Title
Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Achalasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Systematic protein pump inhibitor therapy
Arm Type
Experimental
Arm Title
Protein pump inhibitor therapy as necessary
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Protein pump inhibitor therapy systematically
Intervention Description
Lansoprazole 30mg once per day
Primary Outcome Measure Information:
Title
Presence of pathological acid reflux between groups
Description
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
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Presence of pathological acid reflux between groups
Description
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
Time Frame
Month 12
Title
Patient quality of life between groups
Description
WHOQOL-BREF questionnaire
Time Frame
Week 6
Title
Patient quality of life between groups
Description
WHOQOL-BREF questionnaire
Time Frame
Month 6
Title
Patient quality of life between groups
Description
WHOQOL-BREF questionnaire
Time Frame
Month 12
Title
Patient health-related quality of life between groups
Description
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Time Frame
Week 6
Title
Patient health-related quality of life between groups
Description
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Time Frame
Month 6
Title
Patient health-related quality of life between groups
Description
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Time Frame
Month 12
Title
Quantity of PPI consumed between groups
Description
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Time Frame
Month 3
Title
Quantity of PPI consumed between groups
Description
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Time Frame
Month 6
Title
Quantity of PPI consumed between groups
Description
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Time Frame
Month 12
Title
Treatment tolerance between groups
Description
Occurrence of adverse events as recorded by the doctor during patient interview using a scale of Grade 1 (minor) to Grade 5 (death)
Time Frame
Month 12
Title
Achalasia symptoms between groups
Description
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Time Frame
Week 6
Title
Achalasia symptoms between groups
Description
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Time Frame
Month 6
Title
Achalasia symptoms between groups
Description
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Time Frame
Month 12
Title
Pyrosis symptoms between groups
Description
Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
Time Frame
Month 6
Title
Pyrosis symptoms between groups
Description
Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine Debourdeau
Phone
06.68.31.94.89
Email
a-debourdeau@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Debourdeau
Organizational Affiliation
CHU de Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HM
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Michel Gonzalez
Phone
06.22.25.02.50
Email
jean-michel.gonzalez@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
ean Michel Gonzalez
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Debourdeau
Phone
06.68.31.94.89
Email
antoinedebourdeau@hotmail.com
First Name & Middle Initial & Last Name & Degree
Antoine Debourdeau
Facility Name
Clinique mutualiste Beausoleil
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Combes
Phone
06.76.59.23.48
Email
roman.combes@hotmail.fr
First Name & Middle Initial & Last Name & Degree
Roman Combes
Facility Name
CHU de Nîmes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Ludovic Caillo

12. IPD Sharing Statement

Learn more about this trial

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

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