Pyloric Sphincter Pressure and Geometry Assessment Using EndoFlip
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/2/2016 |
| Start Date: | May 2015 |
| End Date: | June 2017 |
| Contact: | Henry P. Parkman, MD |
| Email: | henry.parkman@temple.edu |
| Phone: | 215-707-9900 |
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.
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.
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.
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.
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
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