Gastroparesis Registry 2

Study Overview
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Brief Summary
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To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.

Detailed Description
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The Gastroparesis Registry 2 (GpR 2) will enroll new patients and patients from the initial NIDDK Gastroparesis Clinical Research Consortium Gastroparesis Registry (GpR) of gastroparesis patients which was initiated in February 2007 and completed in March 2011. To continue to follow and expand the data collections of a well-characterized cohort to further define the natural history and clinical course of gastroparesis. To provide a reliable source for recruitment of well-characterized patients with gastroparesis for therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies. These subsequent clinical trials or ancillary studies will be conducted under separate study protocols with separate consent processes.

Official Title
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GpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients

Conditions
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Gastroparesis, Diabetic Gastroparesis, Idiopathic Gastroparesis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic<br>participants with a primary etiology of diabetic gastroparesis | |
| Idiopathic<br>participants with a primary etiology of idiopathic gastroparesis | |
| Post-Nissen<br>participants with a primary etiology of post-Nissen fundoplication gastroparesis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastroparesis, idiopathic gastroparesis, diabetic gastroparesis, post-Nissen gastroparesis