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

NCT ID: NCT02905669

Last Updated: 2022-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-13

Study Completion Date

2024-05-25

Brief Summary

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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

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Conditions

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Esophageal Dysfunction Pylorus Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EndoFLIP

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

Group Type EXPERIMENTAL

EndoFLIP

Intervention Type DEVICE

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

Interventions

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EndoFLIP

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sabine ROMAN, MD, PhD

Role: CONTACT

+33472110146

Facility Contacts

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Sabine ROMAN, MD, PhD

Role: primary

+33472110146

Other Identifiers

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69HCL16_0457

Identifier Type: -

Identifier Source: org_study_id

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