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

NCT05899842 | Recruiting

• 1 other identifier: AOIGCSMERRI/2020/LC-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 4

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.

Conditions

Esophageal Achalasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Presence of pathological acid reflux between groups

  Month 12

• Patient quality of life between groups

  Week 6

• Patient quality of life between groups

  Month 6

• Patient quality of life between groups

  Month 12

• Patient health-related quality of life between groups

  Week 6

Study Arms (2)

Systematic protein pump inhibitor therapy

EXPERIMENTAL

Drug: Protein pump inhibitor therapy systematically

Protein pump inhibitor therapy as necessary

NO INTERVENTION

Interventions

Protein pump inhibitor therapy systematically DRUG

Lansoprazole 30mg once per day

Systematic protein pump inhibitor therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (4)

AP-HM

Marseille, France

RECRUITING

CHU de Montpellier

Montpellier, France

RECRUITING

Clinique mutualiste Beausoleil

Montpellier, France

RECRUITING

CHU de Nîmes

Nîmes, France

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Antoine Debourdeau

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Debourdeau

CONTACT

06.68.31.94.89; a-debourdeau@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

FR (4)