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

Not Applicable

• Conditions: Esophageal Dysfunction; Pylorus Dysfunction
• Interventions: Device: EndoFLIP

• Registration Number: NCT02905669
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Study Start: 2017-09-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-21
• Primary Completion: 2024-05-25
• Study Completion: 2024-05-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EndoFLIP	EndoFLIP	Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device.

Primary Outcome Measures

Name	Time	Method
Esophago-gastric junction distensibility	The day of gastro-intestinal endoscopy

Secondary Outcome Measures

Name	Time	Method
Side effects occurence	The day after gastro-intestinal endoscopy	Occurrence of pain, aspiration and vomiting
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

Trial Locations

Locations (1)

Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot; 🇫🇷 LYON cedex 03, France