Gastroparesis Registry 3
Key facts
- Who runs it
- Johns Hopkins Bloomberg School of Public Health
- Where
- Baltimore, Boston, El Paso, Louisville, Philadelphia, and Winston-Salem, United StatesSee the 6 sites
- Trial code
- Status
- Completed
- People taking part
- 406 people enrolled
- Started
- 24 Jan 2019
- Ended
- 13 May 2024
- Type of study
- Observational, 6 groups
- Record updated
- 24 May 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- Symptoms of gastroparesis of at least 12 weeks' duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness
- An etiology of either diabetic, idiopathic, or post-fundoplication (Nissen, Dor, or Toupet) gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying)
- Gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) 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 gastric emptying study. (This group will comprise ~75% of patients in the registry.)
- Patients with a normal gastric emptying rate, but who have symptoms of gastroparesis. (This group will comprise ~25% of patients in the registry.)
- Negative upper endoscopy or upper radiographic GI series within 2 years of registration
- Age at least 18 years at initial screening visit
Who cannot take part
- Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy. Note: patients with prior Nissen, Dor, or Toupet fundoplication will be eligible for enrollment
- Inability to comply with or complete the gastric emptying test by scintigraphy (including allergy to eggs)
- Presence of other conditions that could explain the patient's symptoms:
- Active inflammatory bowel disease
- Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
- Acute renal failure
- Acute liver failure
- Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
- Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
- Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
- Use of narcotic analgesics greater than three days per week
- Pyloric or intestinal obstruction: by EGD, UGI, or Abdominal CT
- Known eosinophilic gastroenteritis or eosinophilic esophagitis
- Inability to obtain informed consent
Where in United States
- Johns Hopkins Bayview Medical CenterBaltimore, United StatesNo longer taking part
- Massachusetts General Hospital-Digestive Healthcare CenterBoston, United StatesNo longer taking part
- Texas Tech University Health Science Center (TTUHSC)El Paso, United StatesNo longer taking part
- University of LouisvilleLouisville, United StatesNo longer taking part
- Temple University HospitalPhiladelphia, United StatesNo longer taking part
- Wake Forest University Health SciencesWinston-Salem, United StatesNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to create a new registry of patients with gastroparesis in order to better understand the characteristics of patients with gastroparesis and follow how their condition changes over time. The data collected may improve the understanding of the condition to enable better diagnosis and treatment.
The 6 groups in the trial
- Diabetic
Participants with a primary etiology of diabetic gastroparesis
- Idiopathic
Participants with a primary etiology of idiopathic gastroparesis
- Post-fundoplication
Participants with a primary etiology of post-Nissen fundoplication gastroparesis
- Diabetic with Normal Emptying
Diabetic participants with symptomatic nausea and vomiting with normal gastric emptying
- Idiopathic with Normal Emptying
Idiopathic participants with symptomatic nausea and vomiting with normal gastric emptying
- Post-fundoplication with Normal Emptying
Post-fundoplication participants with symptomatic nausea and vomiting with normal gastric emptying
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The NIDDK Gastroparesis Registry 3: Characterization and Clinical Course of Symptoms and Gastric Emptying in Patients With Symptoms of Gastroparesis
- Record updated
- 24 May 2024