Pyloric Sphincter Pressure and Geometry Assessment Using EndoFlip

NCT02446119 | Unknown

• 1 other identifier: 21560
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pyloric pressure

  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.

  60 minutes

Study Arms (2)

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

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

Interventions

EndoFLIP DEVICE

Measurement of pyloric resistance and compliance

Gastroparesis; Normals

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henry P Parkman, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry P. Parkman, MD

CONTACT

215-707-9900; henry.parkman@temple.edu

Amiya Palit

CONTACT

215-707-5477; amiya.palit@temple.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2015
• First Posted: May 18, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 17, 2020

Record last verified: 2020-08

Locations

US (1)