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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Dysfunction; Pylorus Dysfunction
• Intervention / Treatment: Device: EndoFLIP

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabine ROMAN, MD, PhD; Phone Number: +33472110146; Email: sabine.roman@chu-lyon.fr

Study Locations

• France
  • LYON cedex 03, France, 69437
    • Recruiting
    • Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot
    • Contact: Sabine ROMAN, MD, PhD; Phone Number: +33472110146; Email: sabine.roman@chu-lyon.fr
    • Principal Investigator: Sabine ROMAN, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Anticipated): May 25, 2024
• Study Completion (Anticipated): May 25, 2024

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: esophagus; distensibility; impedance planimetry; esophago-gastric junction; pylorus
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases
• Other Study ID Numbers: 69HCL16_0457

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No