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

NCT ID: NCT03596476

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2027-05-03

Brief Summary

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

Gastro-esophageal Reflux Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with persistent GERD

Patients with persistent GERD suggestive symptoms despite PPI therapy. All the patients will undergo an upper gastrointestinal (GI) endoscopy, a wireless pH monitoring and a post prandial esophageal High Resolution Impedance Manometry (HRIM). Optional: 24-h pH-impedance monitoring on PPI

Group Type: EXPERIMENTAL

Upper gastrointestinal (GI) endoscopy

Intervention Type: PROCEDURE

An upper gastrointestinal (GI) endoscopy will be performed at V1. Four esophageal biopsies will be taken in both the proximal and the distal esophagus.

Wireless pH monitoring

Intervention Type: PROCEDURE

Wireless pH monitoring will be performed at V1. The pH capsule will be clipped into the esophagus during the upper GI endoscopy. The esophageal pH will be recorded for 96 hours (ambulatory recording).

Post prandial esophageal High Resolution Impedance Manometry

Intervention Type: PROCEDURE

Post prandial esophageal HRIM will be performed at V2. The recording will be started after transnasal insertion of the HRIM probe. A standardized meal will be given to the patient (Big Mac, medium portion of French fries, orange juice). The recording will be realized for one hour after the end of the meal.

pH-impedance monitoring

Intervention Type: PROCEDURE

24-h pH-impedance monitoring on PPI will be performed at V3. A transnasal catheter will be inserted into the esophagus and the recording will be performed for 24 hours (ambulatory recording).

Interventions

Upper gastrointestinal (GI) endoscopy

An upper gastrointestinal (GI) endoscopy will be performed at V1. Four esophageal biopsies will be taken in both the proximal and the distal esophagus.

Intervention Type: PROCEDURE

Wireless pH monitoring

Wireless pH monitoring will be performed at V1. The pH capsule will be clipped into the esophagus during the upper GI endoscopy. The esophageal pH will be recorded for 96 hours (ambulatory recording).

Intervention Type: PROCEDURE

Post prandial esophageal High Resolution Impedance Manometry

Post prandial esophageal HRIM will be performed at V2. The recording will be started after transnasal insertion of the HRIM probe. A standardized meal will be given to the patient (Big Mac, medium portion of French fries, orange juice). The recording will be realized for one hour after the end of the meal.

Intervention Type: PROCEDURE

pH-impedance monitoring

24-h pH-impedance monitoring on PPI will be performed at V3. A transnasal catheter will be inserted into the esophagus and the recording will be performed for 24 hours (ambulatory recording).

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Chambray-lès-Tours, , France

Site Status: RECRUITING

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

Colombes, , France

Site Status: RECRUITING

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

Lyon, , France

Site Status: RECRUITING

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

Nantes, , France

Site Status: RECRUITING

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

Pessac, , France

Site Status: RECRUITING

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

Rennes, , France

Site Status: RECRUITING

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

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sabine ROMAN, MD

Role: CONTACT

sabine.roman@chu-lyon.fr

4 72 11 01 36 ext. +33

Facility Contacts

Alexandre AUBOURG, MD

Role: primary

Benoit COFFIN, MD

Role: primary

Sabine ROMAN, MD

Role: primary

Stanislas BRULEY DES VARANNES, MD

Role: primary

Frank ZERBIB, MD

Role: primary

Marion CHAMBAZ, MD

Role: primary

Guillaume GOURCEROL, MD

Role: primary

Other Identifiers

2018-A01591-54

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0043

Identifier Type: -

Identifier Source: org_study_id