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

Esophageal Dysfunction Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02905669
• Other study ID #: 69HCL16_0457
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2017
• Est. completion date: May 25, 2024

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: Sabine ROMAN, MD, PhD
• Phone: +33472110146
• Email: sabine.roman[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 25, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Diseases
• Esophageal Dysfunction
• Pylorus Dysfunction

Intervention

Device:
• EndoFLIP
Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device

Locations

Country	Name	City	State
France	Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot	LYON cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophago-gastric junction distensibility		The day of gastro-intestinal endoscopy
Secondary	Esophageal distensibility		The day of gastro-intestinal endoscopy
Secondary	Pylorus distensibility		The day of gastro-intestinal endoscopy
Secondary	Esophageal contractile activity in response to distension	distension volume for presence of esophageal repetitive contraction	The day of gastro-intestinal endoscopy
Secondary	Side effects occurence	Occurrence of pain, aspiration and vomiting	The day of gastro-intestinal endoscopy
Secondary	Side effects occurence	Occurrence of pain, aspiration and vomiting	The day after gastro-intestinal endoscopy