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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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).
• Процедура 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.
• Процедура 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).

Первичные конечные точки

• Number of reflux episodes identified on the post prandial HRIM [Срок оценки: 1 hour after the end of the meal]

Вторичные конечные точки (9)

• Acid exposure time measured on wireless pH-monitoring [Срок оценки: 4 days]
• Reflux mechanisms defined on post prandial HRIM [Срок оценки: 1 hour after the end of the meal]
• Baseline impedance measured on post prandial HRIM [Срок оценки: 1 hour after the end of the meal]
• Resting pressure of the esophago-gastric junction [Срок оценки: 1 hour]
• Esophageal histology [Срок оценки: 4 weeks]
• Response to 4-week regimen of dose PPI [Срок оценки: 4 weeks]
• Normalization of the number of reflux episodes detected on 24-h pH-impedance monitoring performed on PPI [Срок оценки: 1 day]
• Normalization of the acid exposure time measured on 24-h pH-impedance monitoring performed on PPI [Срок оценки: 1 day]
• Patient's preference regarding the type of examination [Срок оценки: 1 day]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 7 центров

• Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours — Chambray-lès-Tours
• Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP — Colombes
• Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL — Lyon
• Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes — Nantes
• Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux — Pessac
• Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes — Rennes
• Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen — Rouen

Идентификаторы

NCT: NCT03596476 · 69HCL18_0043 · 2018-A01591-54

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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