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

Primary Purpose

Esophageal Dysfunction, Pylorus Dysfunction

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

EndoFLIP

About this trial

This is an interventional diagnostic trial for Esophageal Dysfunction focused on measuring distensibility, impedance planimetry, esophagus, esophago-gastric junction, pylorus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Exploration Fonctionnelle Digestive, Hôpital Edouard HerriotRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EndoFLIP

Arm Description

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

Outcomes

Primary Outcome Measures

Esophago-gastric junction distensibility

Secondary Outcome Measures

Esophageal distensibility

Pylorus distensibility

Esophageal contractile activity in response to distension

distension volume for presence of esophageal repetitive contraction

Side effects occurence

Occurrence of pain, aspiration and vomiting

Side effects occurence

Occurrence of pain, aspiration and vomiting

Full Information

NCT ID

NCT02905669

First Posted

September 9, 2016

Last Updated

March 18, 2022

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT02905669

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 13, 2017 (Actual)

Primary Completion Date

May 25, 2024 (Anticipated)

Study Completion Date

May 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Dysfunction, Pylorus Dysfunction

Keywords

distensibility, impedance planimetry, esophagus, esophago-gastric junction, pylorus

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EndoFLIP

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

EndoFLIP

Intervention Description

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

Primary Outcome Measure Information:

Title

Esophago-gastric junction distensibility

Time Frame