Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03324074
Status:
COMPLETED
Last Update Posted:
2019-07-02
First Post:
2017-10-17
Brief Title:
Assessment of Pyloric Sphincter Physiology
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
Assessment of Pyloric Sphincter Physiology Using EndoFLIP
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pylorus is a tubular structure which contains circular muscle forming pyloric sphincter which separates stomach and duodenum The motor activity of the pyloric sphincter is less investigated Antroduodenal manometry is an invasive and time consuming technique also limited by inability to measure compliance of the sphincter
Recently a new technique functional lumen imaging probe FLIP which is based on principle of impedance planimetry IP The endoluminal FLIP EndoFLIP EF -100 system uses a multi-detector IP system to produce a 3-dimensional outline of a sphincter EndoFLIP can measure tissue distensibility and geometric changes through volumetric distention with real-time images The esophagogastric junction EGJ has been well studied using EndoFLIP studies for assessment of pyloric function are lacking
Recently a new technique functional lumen imaging probe FLIP which is based on principle of impedance planimetry IP The endoluminal FLIP EndoFLIP EF -100 system uses a multi-detector IP system to produce a 3-dimensional outline of a sphincter EndoFLIP can measure tissue distensibility and geometric changes through volumetric distention with real-time images The esophagogastric junction EGJ has been well studied using EndoFLIP studies for assessment of pyloric function are lacking
Detailed Description:
Objective
To evaluate the motor activity of pyloric sphincter using Endo FLIP in the form of pressure diameter cross-sectional area CSA and distensibility in the healthy volunteers
Methods 20 healthy volunteers will be recruited by local advertising hospital staff and hospitalised patients relatives They will be screened for evidence of organic or functional gastrointestinal disorders if found to have any will be excluded Subjects on any medication that is known to affect gastrointestinal function will be excluded
EndoFLIP method
The subjects will be fasting for at least 8 hours prior to the study The study will be performed under sedation using monitored anesthesia using propofol in the left lateral decubitus position Initial endoscopic examination will be performed up to the antrum without traversing the pylorus using 160 OlympusAn EndoFLIP catheter will be passed through biopsy channel into pylorus under direct endoscopic and fluoroscopic visualization
Pylorus will be assessed using EndoFLIP at 20 30 40 and 50 cc balloon volume distentions Pressure will be measured by pressure transducer inside the balloon CSA will be measured using impedance planimetry by Ohms Law Distensibility will be calculated as minimum CSA divided by pressure at each balloon fill volume These measurement will be assessed after the balloon inflated at each balloon distension for minimum of 5 seconds The length of the pylorus will be assessed visually from EndoFLIP images Once the EndoFLIP measurements completed at rest Injection hyoscine 10mg intravascular will be administered and same measurements will be repeated Thereafter remaining endoscopic exam will be completed
This is an observational study with no intervention
To evaluate the motor activity of pyloric sphincter using Endo FLIP in the form of pressure diameter cross-sectional area CSA and distensibility in the healthy volunteers
Methods 20 healthy volunteers will be recruited by local advertising hospital staff and hospitalised patients relatives They will be screened for evidence of organic or functional gastrointestinal disorders if found to have any will be excluded Subjects on any medication that is known to affect gastrointestinal function will be excluded
EndoFLIP method
The subjects will be fasting for at least 8 hours prior to the study The study will be performed under sedation using monitored anesthesia using propofol in the left lateral decubitus position Initial endoscopic examination will be performed up to the antrum without traversing the pylorus using 160 OlympusAn EndoFLIP catheter will be passed through biopsy channel into pylorus under direct endoscopic and fluoroscopic visualization
Pylorus will be assessed using EndoFLIP at 20 30 40 and 50 cc balloon volume distentions Pressure will be measured by pressure transducer inside the balloon CSA will be measured using impedance planimetry by Ohms Law Distensibility will be calculated as minimum CSA divided by pressure at each balloon fill volume These measurement will be assessed after the balloon inflated at each balloon distension for minimum of 5 seconds The length of the pylorus will be assessed visually from EndoFLIP images Once the EndoFLIP measurements completed at rest Injection hyoscine 10mg intravascular will be administered and same measurements will be repeated Thereafter remaining endoscopic exam will be completed
This is an observational study with no intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None