Assessment of Pyloric Sphincter Physiology

July 1, 2019 updated by: Rakesh K, Asian Institute of Gastroenterology, India

Assessment of Pyloric Sphincter Physiology Using EndoFLIP

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.

Study Overview

Status

Completed

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 patient's 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 Olympus).An 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 Ohm's 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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Rakesh K

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inclusion Criteria:

  • Adult >18 years and < 60 years, Both males and females.
  • Healthy volunteers willing to give written informed consent.

Description

Inclusion Criteria:

  • Adult >18 years and < 60 years, Both males and females.
  • Healthy volunteers willing to give 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 or equal to 50
  • Incapability to give consent
  • No written informed consent
  • Participation to another study at the same time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of pyloric sphincter pressure
Time Frame: 1 day
To evaluate the pyloric sphincter pressure using EndoFLIP in the healthy volunteers.
1 day
Assessment of pyloric sphincter diameter
Time Frame: 1 day
To evaluate the pyloric sphincter diameter using EndoFLIP in the healthy volunteers.
1 day
Assessment of pyloric sphincter cross-sectional area
Time Frame: 1 day
To evaluate the pyloric sphincter cross-sectional area using EndoFLIP in the healthy volunteers.
1 day
Assessment of pyloric sphincter distensibility
Time Frame: 1 day
To evaluate the pyloric sphincter distensibility using EndoFLIP in the healthy volunteers.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Dr. D. Nageshwar Reddy, MD,DM, Asian Institute Of Gastroenterology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2018

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 27, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • EndoFLIP01.Ver.01.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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