Esophageal Dysfunction, Pylorus Dysfunction
Conditions
Keywords
distensibility, impedance planimetry, esophagus, esophago-gastric junction, pylorus
Brief summary
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.
Interventions
DEVICEEndoFLIP
Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Esophago-gastric junction distensibility | The day of gastro-intestinal endoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal distensibility | The day of gastro-intestinal endoscopy | — |
| Pylorus distensibility | The day of gastro-intestinal endoscopy | — |
| Esophageal contractile activity in response to distension | The day of gastro-intestinal endoscopy | distension volume for presence of esophageal repetitive contraction |
| Side effects occurence | The day of gastro-intestinal endoscopy | Occurrence of pain, aspiration and vomiting |
Countries
France
Contacts
Primary ContactSabine ROMAN, MD, PhD
Outcome results
None listed