Status:
COMPLETED
Gastroparesis Registry
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Gastroparesis
Eligibility:
All Genders
18+ years
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 prov...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
591 Patients enrolled
Trial Details
Trial ID
NCT00398801
Start Date
December 1 2006
End Date
March 1 2011
Last Update
February 23 2022
Active Locations (7)
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1
California Pacific Medical Center
San Francisco, California, United States, 94115
2
Stanford University
Stanford, California, United States, 94305-5187
3
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
4
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216