The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.
Age at least 18 years at initial screening visit
Symptoms of Gp and/or FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome.
Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 9 months
Negative upper endoscopy or upper radiographic GI series within 5 years of registration
Use of narcotic analgesics greater than three days per week
Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
Active inflammatory bowel disease
Known eosinophilic gastroenteritis or eosinophilic esophagitis
Adults over age 18, located in the United States, with symptoms of gastroparesis and/or functional dyspepsia.
Cohort
Prospective
Not listed
Measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.
Change in PAGI-SYM total score from baseline to 48 weeks. The final PAGI-SYM contains 20 items grouped into 6 subscales covering: heartburn/regurgitation (7 items), nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). A 6-point Likert response scale, ranging from 0 (none) to 5 (very severe), is used for rating the severity of each symptom item over a 2-week recall period. * Subscale scores vary from 0 to 5 * Total score varies from 0 to 5 * Lower score = better health
Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks
Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks. Normal values for gastric emptying scintigraphy have been established in earlier studies using healthy volunteers. Gastric retention of 99mTc \> 60% at 2 hours and/or \> 10% at 4 hours is considered evidence of delayed gastric emptying of solids.
Presence or absence of Carnett's sign for abdominal wall pain at baseline.
Presence or absence Carnett's sign for abdominal wall pain at baseline. Carnett's sign is a finding on clinical examination in which (acute) abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed. As part of the abdominal examination, the patient is asked to lift the head and shoulders from the examination table to tense the abdominal muscles. An alternative is to ask the patient to raise both legs with straight knees. A positive test indicates the increased likelihood that the abdominal wall and not the abdominal cavity is the source of the pain (for example, due to rectus sheath hematoma instead of appendicitis). A negative Carnett's sign is said to occur when the abdominal pain decreases when the patient is asked to lift the head; this points to an intra-abdominal cause of the pain
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Johns Hopkins Bloomberg School of Public Health
Lead sponsor
Texas Tech University Health Sciences Center, El Paso
Collaborator
Temple University
Collaborator
University of Louisville
Collaborator
Mayo Clinic
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Massachusetts General Hospital
Collaborator
Wake Forest University
Collaborator
