Interest of systematic treatment with PPI after endoscopic myotomy compared to PPI treatment in case of symptoms in prevention of gastroesophageal reflux after POEM for esophageal achalasia. Randomized open-label clinical trial

Phase 1

Recruiting

• Conditions: esophageal achalasia; MedDRA version: 20.0Level: LLTClassification code: 10000423Term: Achalasia esophageal Class: 10017947; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2022-500218-25-01
• Lead Sponsor: CHU de Nimes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Patient with an indication for esophageal POEM for achalasia, Patient with all types of achalasia with Eckardt score > 3, Patient with free and informed consent., Patient affiliated or beneficiary of a health insurance plan., Adult patient (=18 years old).

Exclusion Criteria

Patients with contraindications to PPIs (Specify major ICs), Patient with mediastinal and esophageal neoplasia, Patients with a history of Heller myotomy surgery, Patients requiring any type of anti-reflux valve surgery, Patient in an exclusion period determined by another study., Patient under court protection, guardianship or curatorship., Patient for whom it is impossible to give informed information., Pregnant, parturient, or breastfeeding patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified