Recruiting

EndoFlip

Sponsor:

Temple University

Code:

NCT02446119

Conditions

Gastroparesis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

EndoFLIP

Study Details

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.

Conditions

Gastroparesis

Study ID

NCT02446119

Start date

May, 2015

Status verified date

Aug, 2020

Completion date

Jun, 2021

Anticipated

Primary completion date

Jun, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

EndoFLIP

Measurement of pyloric resistance and compliance

Primary outcome measure

  • Pyloric pressure [ Time Frame: 60 minutes ]

Central Contacts and Locations

Locations

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Principal Investigator:

Henry P. Parkman, MD

More Information

Sponsor

Temple University

Last update posted

Aug 17, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Temple University on 2020-08-17.