Gastroparesis Registry

Completed

Conditions studied: Gastroparesis

In brief

The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.

Key facts

Study ID

NCT00398801

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

591

Starts

2006-12-01

Expected to finish

2011-03-01

Last updated by the study team

2022-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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