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Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy

RecruitingNAAges 18 Years - anyAllHospices Civils de Lyon
NCT03596476 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Gastro-esophageal reflux disease (GERD) is defined as the reflux of gastric content into the esophagus that causes troublesome symptoms or complications. Nine to 30% of the population suffers from GERD-suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). In the absence of warning signs, proton pump inhibitors (PPI) are prescribed as first-line treatment. However, 20 to 60% of patients are unsatisfied because of persistent symptoms when taking PPI. Causes of persistent symptoms are: erroneous diagnosis of GERD (up to 50% of PPI non-responders), rumination syndrome, excessive weakly acid reflux on PPI due to defective esophago-gastric junction or an excessive number of transient lower esophageal sphincter relaxations (main mechanism of GERD), poor acid secretion inhibition on PPI, and non-compliance to therapy. Complementary examinations are indicated to

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient older than 18 years * Typical symptoms of GERD (heartburn, regurgitation) at least twice a week despite PPI therapy for at least one month. * Reflux Disease Questionnaire (RDQ) score off PPI \> 3 * Subject with health insurance Exclusion Criteria: * Previous esophago-gastric surgery, * Previous history of developing esophageal or gastric tumor, esophageal stricture, or esophageal varices * Pregnancy (assessment at V0) * Contraindication to general anesthesia, * Contraindications to the wireless capsule pH-monitoring: pacemakers, implantable cardiac defibrillator, * Contraindications to HRIM: inability to tolerate nasal intubation, significant bleeding disorders for which nasal intubation is contraindicated, known esophageal obstruction is preventing the passage of the HRIM probe. * Intolerance or allergy to one component of the test meal, * Intolerance or allergy to PPI, * Inability to give consent, * Mentally unbalanced patients, under supervision or guardianship * Decline to participate in the study, * Participation in another study at the same time
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What it tests

  • Upper gastrointestinal (GI) endoscopy
  • Wireless pH monitoring
  • Post prandial esophageal High Resolution Impedance Manometry
  • pH-impedance monitoring
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Where

7 sites
Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours
Chambray-lès-Tours, France
Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP
Colombes, France
Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL
Lyon, France
Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes
Nantes, France
Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux
Pessac, France
Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes
Rennes, France
Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen
Rouen, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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