Gastroparesis Outcome Longitudinal Database Enrolled Numerically

Recruiting

• Conditions: Gastroparesis
• Interventions: Device: GI Neuromodulation; Drug: Immunotherapy; Procedure: Pyloric Therapies

• Registration Number: NCT03876288
• Lead Sponsor: University of Louisville

Brief Summary

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.

Detailed 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; 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

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People presenting with the Sx of Gp	Pyloric Therapies	People presenting with the symptoms of gastroparesis. The three main interventions are GI neuromodulation, immunotherapy, and pyloric therapies.
People presenting with the Sx of Gp	GI Neuromodulation	People presenting with the symptoms of gastroparesis. The three main interventions are GI neuromodulation, immunotherapy, and pyloric therapies.
People presenting with the Sx of Gp	Immunotherapy	People presenting with the symptoms of gastroparesis. The three main interventions are GI neuromodulation, immunotherapy, and pyloric therapies.

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcome GI Symptoms	Change from baseline to one week to one year	The primary outcome measures are patient symptoms via the traditional gastroparesis patient reported outcome scale. It uses a 0-4 scale from none to worse on GI Symptoms; for example: Nausea,Vomiting, Anorexia/Early Satiety, Bloating/distension, Abdominal Pain. Scored as each item plus a total that is the sum of the individual scales.The five Sx subscales of 0-4 each are summed for a total score range 0-20

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States