Gastroparesis Registry 4

Not yet recruiting

Conditions: Gastroparesis Due to Diabetes Mellitus Type II
Gastroparesis Due to Diabetes Mellitus Type I
Gastro-Intestinal Disorder
Gastroparesis Nondiabetic
Functional Disorder of Gastrointestinal Tract
Gastroparesis

Brief Summary: 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.

Detailed Description: This observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying aims to assess the clinical, pathophysiological, and psychological similarities and differences between patients with Gp, FD.

The primary outcome will be the 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.

Recruitment & Eligibility

Inclusion Criteria

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 6 months
Negative upper endoscopy or upper radiographic GI series within 2 years of registration

Exclusion Criteria

Use of narcotic analgesics greater than three days per week
Presence of other conditions that could explain the patient's symptoms such as:
Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
Active inflammatory bowel disease
Known eosinophilic gastroenteritis or eosinophilic esophagitis
Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
Acute or chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
Pancreatic disorder if present on pancreatic imaging or pancreatic function testing
Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.
Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
Inability to obtain informed consent

Primary Outcome Measures

Name	Time	Method
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.	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

Secondary Outcome Measures

Name	Time	Method
Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks	Baseline, 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.

Locations (6): Jay Pasricha
🇺🇸
Scottsdale, Arizona, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Temple University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Wake Forest University and Atrium Health Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
Texas Tech University Health Science Center (TTUHSC)
🇺🇸
El Paso, Texas, United States