Assessment of Pyloric Sphincter Physiology
Condition: Physiology of Pyloric Sphincter
Study type: Observational [Patient Registry]

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.
    

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.
    

Observational model: Cohort
Time perspective: Cross-Sectional
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.