Gastroparesis Outcome Longitudinal Database Enrolled Numerically (GOLDEN)

University of Louisville (UOFL)

Status: Enrolling

Conditions: Gastroparesis

Treatments: Procedure: Pyloric Therapies; Device: GI Neuromodulation; Drug: Immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03876288

13.0020

Details and patient eligibility

About

GOLDEN is a longitudinal database of patients with the symptoms (Sx) of gastroparesis (Gp) who were seen and recorded at the University of Louisville from 2012 and is ongoing. Patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of the same team and who are reported as part of the series. Outcome relate to patients Sx, survival, quality of life and other measures as detailed below, over time, regardless of whether any treatment was given or not. If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.

Full description

1. All patients seen with the Sx of Gp and who were evaluated for diagnosis and/or treatment
2. Including legacy patients who were seen and treated at previous locations (Mississippi, Arkansas, Tennessee) before Kentucky if they were part of a clinical research series.
3. Numbers of patients referred or consulted for Gp Sx who were Drug Refractory.
4. Interventions: GI Neuromodulation with gastric electrical stimulation (GES); Immunotherapy with Intravenous Immunoglobulin; Pyloric therapies such as pyloroplasty, surgical or endoscopic.
5. Data for evaluation by: Sx assessments by whatever scales used; Measures of health related quality of life; Psychological and pain assessments; Gastric emptying texts; Electrical measures including the following: single channel, low resolution and high resolution EGG, plus mucosal and serosal electrograms. High resolution EGG is also called Body Surface Mapping which is frequently measured in our patient population. ; Autonomic measure; Serologic measures; Full thickness biopsies; Measures of outpatient & Emergency Room Visits; Measures of hospitalization; Placement of endoscopic or surgical tubes; Radiological and Surgical procedures; Nutritional assessments; If enrolled in any research protocols for data; Stool biome measures; Metabolic measures; Other morbidity measures; Mortality

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Patients with the symptoms (Sx) of drug refractory gastroparesis
• Disordered nutrition by standardized assessment
• Ability to assess current symptom status
• Ability to measure other medical conditions

Exclusion:

• Anatomic obstruction of the GI Tract
• Pregnancy
• Inability of patient or guardian to sign informed consent, if needed
• Psychiatric disorders precluding assessment and treatment of the patient's GI condition

Trial design

3,000 participants in 1 patient group

People presenting with the Sx of Gp

Description:

People presenting with the symptoms of gastroparesis. The three main interventions are GI neuromodulation, immunotherapy, and pyloric therapies.

Treatment:

Drug: Immunotherapy

Device: GI Neuromodulation

Procedure: Pyloric Therapies