Gastroparesis Registry
- Conditions
- Gastroparesis
- Registration Number
- NCT00398801
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Brief Summary
The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.
- Detailed Description
The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis. The Gastroparesis Registry will also provide a resource to inform the development of clinical trials and ancillary studies of the epidemiology, etiology, pathophysiology, and impact of gastroparesis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 591
- Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, abdominal pain, early satiety, post-prandial fullness,
- Completion of a 4-hour scintigraphic low fat Egg Beaters gastric emptying study
- Patients with either or both abnormal 2 hour (>60% retention) and 4 hour (>10% retention) gastric emptying will be enrolled and classified as definite gastroparesis (Gp)
- Patients with normal gastric emptying, but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying (GLNGE)
- Age at least 18 years at initial screening visit
- Ability and willingness to participate in follow-up
- Inability to comply with or complete the gastric emptying scintigraphy
- Presence of other conditions that could explain the patient's symptoms:
- Pyloric or intestinal obstruction
- Active inflammatory bowel disease
- Eosinophilic gastroenteritis
- Neurological conditions such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
- Acute liver failure
- Advanced liver disease (Child's B or C)
- Acute renal failure
- Untreated chronic renal failure (serum creatinine >3 mg/dL)
- Total or subtotal gastric resection (patients with prior fundoplication or postvagotomy gastroparesis after pyloroplasty or antrectomy with Billroth I, Billroth II, or Roux-en-Y gastrojejunostomy will be eligible for enrollment)
- Any other plausible structural or metabolic cause
- Any other condition, which in the opinion of the investigator would interfere with study requirements
- Inability to obtain informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Texas Tech University Health Science Center (TTUHSC)
🇺🇸El Paso, Texas, United States
California Pacific Medical Center🇺🇸San Francisco, California, United States