Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03596476

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

Led by Hospices Civils de Lyon · Updated on 2024-06-26

330

Participants Needed

7

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 explain persistent GERD symptoms. Upper gastro-intestinal endoscopy is performed first to rule out an esophageal tumor and to identify erosive esophagitis, a specific sign of GERD. However, it is normal in up to 70% of symptomatic GERD patients. Direct detection of reflux episodes is then requested to confirm GERD. The gold standard for reflux detection is the ambulatory measurement of esophageal pH for 24 to 96 hours using a catheter (catheter-based pH-monitoring) or a capsule clipped into the esophagus (wireless pH-monitoring). Reflux episodes are defined as an esophageal pH \< 4. Another method of reflux detection is based on liquid and gas detection in the esophagus using pH-impedance monitoring. Recently the combination of impedance and esophageal pressure monitoring, called esophageal high resolution impedance manometry (HRIM) was introduced to simultaneously identify reflux episodes and their mechanisms. It has several advantages over esophageal pH measurement: shorter recording duration (1 or 2 hours post prandial) and identification of reflux mechanisms that might guide the choice of the best therapeutic option. Hypothesis: The 1-hour post prandial esophageal HRIM might be useful to diagnose GERD.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient older than 18 years
  • Typical GERD symptoms (heartburn, regurgitation) at least twice a week despite proton pump inhibitor therapy for at least one month
  • Reflux Disease Questionnaire (RDQ) score off PPI greater than 3
  • Subject with health insurance
Not Eligible

You will not qualify if you...

  • Previous esophago-gastric surgery
  • Previous history of esophageal or gastric tumor, esophageal stricture, or esophageal varices
  • Pregnancy
  • Contraindication to general anesthesia
  • Contraindications to wireless capsule pH-monitoring such as pacemakers or implantable cardiac defibrillator
  • Contraindications to HRIM including inability to tolerate nasal intubation, significant bleeding disorders, or known esophageal obstruction preventing probe passage
  • Intolerance or allergy to any component of the test meal
  • Intolerance or allergy to proton pump inhibitors
  • Inability to give consent
  • Mentally unbalanced patients under supervision or guardianship
  • Declining to participate in the study
  • Participation in another study at the same time

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 7 locations

1

Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours

Chambray-lès-Tours, France, 37171

Actively Recruiting

2

Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP

Colombes, France, 92700

Actively Recruiting

3

Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL

Lyon, France, 69437

Actively Recruiting

4

Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes

Nantes, France, 44093

Actively Recruiting

5

Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux

Pessac, France, 33600

Actively Recruiting

6

Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes

Rennes, France, 35033

Actively Recruiting

7

Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen

Rouen, France, 76031

Actively Recruiting

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Research Team

S

Sabine ROMAN, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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