Gastroparesis Outcome Longitudinal Database Enrolled Numerically
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Louisville
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Patient Reported Outcome GI Symptoms
Study Overview
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. The study tracks patients regardless of treatment but specifically focuses on GI Neuromodulation (gastric electrical stimulation - GES), Immunotherapy (IVIG), and Pyloric therapies (pyloroplasty, endoscopic). If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.
Detailed Description
- All patients seen with the Sx of Gp and who were evaluated for diagnosis and/or treatment
- 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.
- Numbers of patients referred or consulted for Gp Sx who were Drug Refractory.
- Interventions: GI Neuromodulation with gastric electrical stimulation (GES); Immunotherapy with Intravenous Immunoglobulin; Pyloric therapies such as pyloroplasty, surgical or endoscopic.
- 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
- One of the areas that GOLDEN looks at is High Resolution EGG or Body Surface Mapping (BSM). This specific area included normal control data along with collaborations with the U of Auckland the Temple University. The goals of the BSM portion of GOLDEN are as follows:
- Goal1: Define Normal Body Surface Gastric Mapping (BSGM) Ranges and Activity Profiles in Adults
- Goal 2. Define Spatial Patterns of Abnormal Gastric Electrophysiology in a Large Patient Cohort
- Goal 3: Define Mechanistic Consequences of Retrograde Gastric Slow Wave Activation on Gastric Emptying, Gastric Contractions, and Reflux Events
Work to meet these goals are ongoing
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
People presenting with the Sx of Gp
People presenting with the symptoms of gastroparesis. The three main interventions are GI neuromodulation, immunotherapy, and pyloric therapies.
Intervention: Pyloric Therapies (Procedure)
People presenting with the Sx of Gp
People presenting with the symptoms of gastroparesis. The three main interventions are GI neuromodulation, immunotherapy, and pyloric therapies.
Intervention: GI Neuromodulation (Device)
People presenting with the Sx of Gp
People presenting with the symptoms of gastroparesis. The three main interventions are GI neuromodulation, immunotherapy, and pyloric therapies.
Intervention: Immunotherapy (Drug)
Outcomes
Primary Outcomes
Patient Reported Outcome GI Symptoms
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Thomas Abell
The Arthur M Schoen MD Chair in Gastroenterology
University of Louisville