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Gastroparesis Registry 2
Trial ID or NCT#
NCT01696747
Status
Purpose
To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.
Official Title
GpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, early satiety, post-prandial fullness, and/or abdominal pain - An etiology of either diabetic, idiopathic, or post-Nissen fundoplication gastroparesis - Gastric emptying scintigraphy of solids and liquids test using 4 hours Egg Beaters® protocol within the last 6 months with either: - Abnormal gastric emptying rate defined as an abnormal 2 hour (>60% retention) and/or 4 hour (>10% retention) result based on a 4-hour scintigraphic low fat Egg Beaters® gastric emptying study performed at a GpCRC clinical center. - Patients with a normal gastric emptying rate but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying - Age at least 18 years at initial screening visit - Upper endoscopy results within last 2 years
Exclusion Criteria:
- - Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs) - Presence of other conditions that could explain the patient's symptoms: - Pyloric or intestinal obstruction as determined by endoscopy, upper GI series or abdominal CT scan - Active inflammatory bowel disease - Known eosinophilic gastroenteritis - Primary neurological conditions that could cause nausea and/or vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions - Acute liver failure - Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7 ) - Acute renal failure - Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis - Total or subtotal (near complete) gastric resection, esophagogastrostomy, gastrojejunostomy, or gastric bypass. Note: patients with prior fundoplication 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
Investigator(s)
Linda Nguyen
Gastroenterologist,
Motility specialist
Clinical Professor, Medicine - Gastroenterology & Hepatology
Contact us to find out if this trial is right for you.
CONTACT
Linda Nguyen, MD
(650) 725-3362
View on ClinicalTrials.gov
About this Clinical Trial
Your Message Will Go To
Linda Nguyen, MD650-725-3362