Gastroparesis Registry 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients (GpR 2)

General Description

Gastroparesis, a syndrome in which patients experience delayed gastric emptying, is characterized by symptoms such as nausea, vomiting, bloating, abdominal pain, and early satiety. Despite the significant morbidity of the condition, research and characterization of the clinical features of gastroparesis are limited, hindered by challenges such as single centers and small study populations. The Gastroparesis Registry (GpR) was an observational study created by the Gastroparesis Clinical Research Consortium (GpCRC) to enroll a sufficiently large number of patients to elucidate the clinical features of the condition and investigate their association with various patient characteristics. Following conclusion of the GpR study, the Gastroparesis Registry 2 (GpR 2) was initiated as follow-up to expand the registry (GpR 2) for continued investigation of the epidemiology, etiology, and clinical course of gastroparesis.

Individuals with symptoms of gastroparesis of at least 12 weeks duration and delayed gastric emptying on scintigraphy are enrolled. Individuals with symptoms of gastroparesis but with normal gastric emptying are also enrolled as a reference group. Participants must have had an upper endoscopy within 2 years prior to registration to rule out other disorders. During screening, data is collected on medical history, physical examination, 4 hour gastric emptying scintigraphy results, and symptoms of gastroparesis and psychological functioning using patient-completed questionnaires. Additionally, diagnostic tests of wireless motility capsule to assess whole gut transit, autonomic function testing, and electrogastrography are done to investigate the pathophysiology of the condition. Patients are followed via site visits every 24 weeks, at which time information is collected on symptoms, quality of life, treatments being used, and change in medical condition. Plasma and serum samples from each participant are collected and stored.

This study is ongoing.

Objectives

The primary objective of the study is to expand the registry of patients with gastroparesis for the study of epidemiology, etiology, and outcomes associated with the condition. The study also aims to provide a reliable source of recruitment of well-characterized patients with gastroparesis for therapeutic clinical trials and ancillary studies.

Criteria

Individuals of at least 18 years of age who met the following criteria are eligible for enrollment:

• 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, and post-prandial fullness.
• An etiology of either diabetic, idiopathic, or post-Nissen fundoplication gastroparesis.
• Completion of a 4-hour scintigraphic gastric emptying study (for classification of definite gastroparesis or gastroparesis-like with normal gastric emptying).
• No abnormality causing obstruction on upper endoscopy, done within 2 years.

Exclusion criteria are documented in the study protocol.

Outcome

This study is ongoing.