Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pyloric Sphincter Pressure and Geometry Assessment Using EndoFlip (PyloEndoFlip)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02446119
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Temple University

Brief Summary:
Gastroparesis is a disorder characterized by symptoms from gastric retention in the absence of mechanical obstruction. Gastric emptying is a highly regulated process reflecting the integration of the propulsive forces of proximal fundic tone and distal antral contractions with the functional resistance provided by the pyloric sphincter. Pylorospasm has been reported in some patients with gastroparesis. This study protocol will assess pyloric sphincter pressure and geometry in patients with gastroparesis and control subjects without symptoms of gastroparesis. The commercially available FDA approved endoscopic functional luminal imaging probe (EndoFLIP) catheter will be used, which measures diameter, pressure, length, and distensibility of gastrointestinal sphincter muscles along the balloon distance. It is used to measure the pressure characteristics of the lower esophageal sphincter during bariatric surgery for obesity, during Heller myotomy for achalasia, and during Nissen fundoplication for gastroesophageal reflux disease. In this study, during upper endoscopy, which is routinely performed under sedation, patients with gastroparesis and controls without gastroparesis symptoms will have their pyloric sphincter assessed with EndoFLIP. After passage of the endoscope into the stomach, the EndoFLIP catheter will be introduced alongside the endoscope and advanced through the pyloric sphincter as visualized endoscopically. The investigators will measure the pressure and contour of the pyloric sphincter using three successive volume distensions of the EndoFLIP balloon (20 ml, 30 ml, 40 ml). The investigators will compare the results between the gastroparesis patients and the control patients without gastroparesis. Through this study, the investigators will better understand the abnormalities of the pyloric sphincter in patients with gastroparesis.

Condition or disease Intervention/treatment
Gastroparesis Device: EndoFLIP

Detailed Description:

This study protocol will assess pyloric sphincter pressure and geometry in patients with gastroparesis and control subjects without symptoms of gastroparesis.

Aims: To determine if there is a subgroup of patients with gastroparesis who have pressure and/or geometric configuration abnormalities of the pyloric sphincter. We will determine this by assessing the pressure, diameter, length, and distensibility of the pyloric sphincter in patients with gastroparesis and in subjects without gastroparesis undergoing upper endoscopy for their clinical evaluation.

Hypothesis:The pylorus of patients with gastroparesis has a higher pressure, smaller diameter, and is less distensible than the pylorus of control patients without gastroparesis

Methods: The commercially available FDA approved endoscopic functional luminal imaging probe (EndoFLIP) catheter will be used, which measures diameter, pressure, length, and distensibility of gastrointestinal sphincter muscles along the balloon distance. It is used to measure the pressure characteristics of the lower esophageal sphincter during bariatric surgery for obesity, during Heller myotomy for achalasia, and during Nissen fundoplication for gastroesophageal reflux disease. In this study, during upper endoscopy, which is routinely performed under sedation, patients with gastroparesis and controls without gastroparesis symptoms will have their pyloric sphincter assessed with EndoFLIP. After passage of the endoscope into the stomach, the EndoFLIP catheter will be introduced alongside the endoscope and advanced through the pyloric sphincter as visualized endoscopically. The investigators will measure the pressure and contour of the pyloric sphincter using three successive volume distensions of the EndoFLIP balloon (20 ml, 30 ml, 40 ml). The assessment of the pylorus will be done during the upper endoscopy which will take approximately 60 minutes. We will compare the pyloric pressure measurements in patients with gastroparesis to the control patients. This is an observational study, with no intervention.

Analysis: The investigators will compare the results between the gastroparesis patients and the control patients without gastroparesis.

Through this study, the investigators will better understand the abnormalities of the pyloric sphincter in patients with gastroparesis.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pyloric Sphincter Pressure and Geometry Assessment Using EndoFlip
Study Start Date : May 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Gastroparesis

Inclusion criteria:

1. Subjects will be of either sex, 18 to 70 years of age.

patients with an established diagnosis of gastroparesis, either diabetic or idiopathic etiology. The gastroparesis subjects will have delayed gastric emptying on gastric scintigraphy defined as greater than 60% retention at 2 hours and/or greater than 10% retention at 4 hours. This gastric emptying test would have been done prior to the endoscopy and is not part of the research study. Patients will undergo EndoFlip during upper endoscopy.

Device: EndoFLIP
Measurement of pyloric resistance and compliance

Normals

Inclusion criteria:

1. Subjects will be of either sex, 18 to 70 years of age.

control subjects will be nondiabetic patients without gastroparesis or gastroesophageal reflux symptoms undergoing upper endoscopy. Patients will undergo EndoFlip during upper endoscopy.

Device: EndoFLIP
Measurement of pyloric resistance and compliance




Primary Outcome Measures :
  1. Pyloric pressure [ Time Frame: 60 minutes ]
    Measurement of pyloric pressure using EndoFLIP in patients with gastroparesis and controls. Our plan is to compare the pyloric pressures in patients with gastroparesis to controls. This is an observational study with no intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Inclusion criteria:

  1. Subjects will be of either sex, 18 to 70 years of age.
  2. Two groups will be recruited. 2a. First, patients with an established diagnosis of gastroparesis, either diabetic or idiopathic etiology. The gastroparesis subjects will have delayed gastric emptying on gastric scintigraphy defined as greater than 60% retention at 2 hours and/or greater than 10% retention at 4 hours.

2b. Second, control subjects will be nondiabetic patients without gastroparesis or gastroesophageal reflux symptoms undergoing upper endoscopy.

Criteria

Inclusion Criteria:

  1. Subjects will be of either sex, 18 to 70 years of age.
  2. Two groups will be recruited:

    • First, patients with an established diagnosis of gastroparesis, either diabetic or idiopathic etiology.
    • Second, control subjects will be nondiabetic patients without gastroparesis or gastroesophageal reflux symptoms undergoing upper endoscopy.

Exclusion criteria Prior surgery involving the stomach


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446119


Contacts
Layout table for location contacts
Contact: Henry P. Parkman, MD 215-707-9900 henry.parkman@temple.edu
Contact: Amiya Palit 215-707-5477 amiya.palit@temple.edu

Locations
Layout table for location information
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry P. Parkman, MD    215-707-3431    henry.parkman@temple.edu   
Principal Investigator: Henry P. Parkman, MD         
Sponsors and Collaborators
Temple University
Investigators
Layout table for investigator information
Principal Investigator: Henry P Parkman, MD Temple University
Layout table for additonal information
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02446119    
Other Study ID Numbers: 21560
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations