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

NARecruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

May 3, 2021

Primary Completion Date

May 3, 2027

Study Completion Date

May 3, 2027

Conditions
Gastro-esophageal Reflux Disease
Interventions
PROCEDURE

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.

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).

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.

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).

Trial Locations (7)

33600

RECRUITING

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

35033

RECRUITING

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

37171

RECRUITING

Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours, Chambray-lès-Tours

44093

RECRUITING

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

69437

RECRUITING

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

76031

RECRUITING

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

92700

RECRUITING

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

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER