Assessing esophageal function in patients with persistent GERD symptoms despite medication
Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy
This study is testing a new way to check how well the esophagus works in people who still have GERD symptoms even after taking medication, to help find better treatments for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 7 sites (Chambray-lès-Tours and 6 other locations) |
| Trial ID | NCT03596476 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of post-prandial esophageal high-resolution impedance manometry in patients suffering from gastro-esophageal reflux disease (GERD) symptoms that persist despite proton pump inhibitor (PPI) therapy. The study aims to identify underlying causes of these persistent symptoms through various diagnostic interventions, including upper gastrointestinal endoscopy and pH-impedance monitoring. By analyzing esophageal function, the trial seeks to improve the accuracy of GERD diagnoses and tailor treatment options for affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who experience typical GERD symptoms at least twice a week despite ongoing PPI treatment.
Not a fit: Patients who have had previous esophago-gastric surgery or have contraindications to the diagnostic procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and improved treatment strategies for patients with GERD who do not respond to standard PPI therapy.
How similar studies have performed: Other studies have shown promise in using high-resolution impedance manometry for diagnosing GERD, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chambray-lès-Tours and 6 other locations
- Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours — Chambray-lès-Tours, France (Recruiting)
- Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP — Colombes, France (Recruiting)
- Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL — Lyon, France (Recruiting)
- Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes — Nantes, France (Recruiting)
- Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux — Pessac, France (Recruiting)
- Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes — Rennes, France (Recruiting)
- Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Sabine ROMAN, MD
- Email: sabine.roman@chu-lyon.fr
- Phone: 4 72 11 01 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.