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
Sponsored by
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
The day of gastro-intestinal endoscopy
Secondary Outcome Measure Information:
Title
Esophageal distensibility
Time Frame
The day of gastro-intestinal endoscopy
Title
Pylorus distensibility
Time Frame
The day of gastro-intestinal endoscopy
Title
Esophageal contractile activity in response to distension
Description
distension volume for presence of esophageal repetitive contraction
Time Frame
The day of gastro-intestinal endoscopy
Title
Side effects occurence
Description
Occurrence of pain, aspiration and vomiting
Time Frame
The day of gastro-intestinal endoscopy
Title
Side effects occurence
Description
Occurrence of pain, aspiration and vomiting
Time Frame
The day after gastro-intestinal endoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine ROMAN, MD, PhD
Phone
+33472110146
Email
sabine.roman@chu-lyon.fr
Facility Information:
Facility Name
Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot
City
LYON cedex 03
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine ROMAN, MD, PhD
Phone
+33472110146
Email
sabine.roman@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Sabine ROMAN, MD, PhD
12. IPD Sharing Statement
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Normal Values for Esophageal and Pyloric Impedance Planimetry Under General Anesthesia (NormaFLIP)
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