Gastroparesis Registry

Completed

• Conditions: Gastroparesis

• Registration Number: NCT00398801
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.

Detailed Description

The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis. The Gastroparesis Registry will also provide a resource to inform the development of clinical trials and ancillary studies of the epidemiology, etiology, pathophysiology, and impact of gastroparesis.

Study Timeline

• Study First Submitted: 2006-11-13
• Study First Submitted QC: 2006-11-13
• Study First Posted: 2006-11-14
• Study Start: 2006-12
• Primary Completion: 2010-03
• Study Completion: 2011-03
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 591

Inclusion Criteria

• Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, abdominal pain, early satiety, post-prandial fullness,
• Completion of a 4-hour scintigraphic low fat Egg Beaters gastric emptying study
• Patients with either or both abnormal 2 hour (>60% retention) and 4 hour (>10% retention) gastric emptying will be enrolled and classified as definite gastroparesis (Gp)
• Patients with normal gastric emptying, but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying (GLNGE)
• Age at least 18 years at initial screening visit
• Ability and willingness to participate in follow-up

Exclusion Criteria

• Inability to comply with or complete the gastric emptying scintigraphy
• Presence of other conditions that could explain the patient's symptoms:
• Pyloric or intestinal obstruction
• Active inflammatory bowel disease
• Eosinophilic gastroenteritis
• Neurological conditions such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
• Acute liver failure
• Advanced liver disease (Child's B or C)
• Acute renal failure
• Untreated chronic renal failure (serum creatinine >3 mg/dL)
• Total or subtotal gastric resection (patients with prior fundoplication or postvagotomy gastroparesis after pyloroplasty or antrectomy with Billroth I, Billroth II, or Roux-en-Y gastrojejunostomy 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Tech University Health Science Center (TTUHSC); 🇺🇸 El Paso, Texas, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States