Clinical trial NCT02905669: Normal Values for Esophageal and Pyloric Impedance Planimetry Under General Anesthesia (NormaFLIP)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Dysfunction
Pylorus Dysfunction
Keywords: distensibility
impedance planimetry
esophagus
esophago-gastric junction
pylorus
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Esophago-gastric junction distensibility
timeFrame: The day of gastro-intestinal endoscopy
Secondary outcomes:
measure: Esophageal distensibility
timeFrame: The day of gastro-intestinal endoscopy
measure: Pylorus distensibility
timeFrame: The day of gastro-intestinal endoscopy
measure: Esophageal contractile activity in response to distension
timeFrame: The day of gastro-intestinal endoscopy
measure: Side effects occurence
timeFrame: The day of gastro-intestinal endoscopy
measure: Side effects occurence
timeFrame: The day after gastro-intestinal endoscopy
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot
Study officials:
References: