Normal Values for Esophageal and Pyloric Impedance Planimetry Under General Anesthesia (NormaFLIP)

Study Overview
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Brief Summary
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Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. It allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. Examination is useful performed under sedation. General anesthesia might affect distensibility values. The aim of this study is to normal values for esophageal, esophago-gastric junction and pylorus distensibility in controls during an upper gastro-intestinal endoscopy performed under general anesthesia.

Official Title
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Measurement of Contractile Activity and Distensibility of the Esophago-gastric Junction, of the Esophagus and of the Pylorus: Normal Values in Controls Under General Anesthesia (NormaFLIP Study)

Conditions
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Esophageal Dysfunction, Pylorus Dysfunction

Intervention / Treatment
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* Device: EndoFLIP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject older than 18 years and younger than 80 years Subject referred for upper gastro-intestinal endoscopy under general anesthesia for anemia, intestinal metaplasia in the stomach, Helicobacter pylori screening, or submucosal dissection Subject with health insurance Written informed consent Exclusion Criteria: Patient younger than 18 years or older than 80 years Pregnancy or breast feeding Previous history of esophago-gastric surgery or vagotomy Previous history of Parkinson disease or diabetes mellitus Contra-indication to upper gastro-intestinal endoscopy Esophageal varices Esophageal diameter smaller than 5 mm Contra-indication to general anesthesia Hiatal hernia greater than 3 cm on endoscopy Esophageal or gastric cancer otherwise than superficial lesion with indication of submucosal dissection Typical symptoms (heartburn, regurgitation) of gastro-esophageal reflux disease and/or gastroesophageal reflux disease (GERD)-Q score greater or equal to 8 Nausea, vomiting or epigastric pain Dysphagia with Sydney score greater ou equal to 50 Incapability to give consent No written informed consent Participation to another study at the same time

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EndoFLIP<br>Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device. | Device: EndoFLIP<br>* Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophago-gastric junction distensibility |  | The day of gastro-intestinal endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal distensibility |  | The day of gastro-intestinal endoscopy | 
| Pylorus distensibility |  | The day of gastro-intestinal endoscopy | 
| Esophageal contractile activity in response to distension | distension volume for presence of esophageal repetitive contraction | The day of gastro-intestinal endoscopy | 
| Side effects occurence | Occurrence of pain, aspiration and vomiting | The day of gastro-intestinal endoscopy | 
| Side effects occurence | Occurrence of pain, aspiration and vomiting | The day after gastro-intestinal endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distensibility, impedance planimetry, esophagus, esophago-gastric junction, pylorus