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

Civil Hospices of Lyon

Status: Unknown

Conditions: Pylorus Dysfunction; Esophageal Dysfunction

Treatments: Device: EndoFLIP

Study type: Interventional

Funder types: Other

Identifiers

NCT02905669

69HCL16_0457

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

EndoFLIP

Experimental group

Description:

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

Treatment:

Device: EndoFLIP