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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.
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:
Work to meet these goals are ongoing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GI Neuromodulation | Device | The investigators would include follow up with: No treatment; temp GES only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome GI Symptoms | 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 | Change from baseline to one week to one year |
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Inclusion:
Exclusion:
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All patients seen
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Abell, MD | Contact | (502)852-6991 | thomas.abell@louisville.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Abell, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41307525 | Derived | Kasem F, Naing LY, Mathur P, McElmurray L, Moppins C, Daniels MW, Stocker A, Abell TL, Omer E. Patients With Gastroparesis Symptoms After Gastric Electrical Stimulation With and Without Tube Feedings. Neuromodulation. 2025 Nov 26:S1094-7159(25)00687-7. doi: 10.1016/j.neurom.2025.07.008. Online ahead of print. | |
| 36626193 | Derived |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D016756 | Immunoglobulins, Intravenous |
| D000074882 | Pyloromyotomy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007074 | Immunoglobulin G |
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Laboratory testing, both clinical and research
|
|
| Immunotherapy | Drug | The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used. |
|
|
| Pyloric Therapies | Procedure | The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used. |
|
|
| Kochar T, Cai W, Guardiola JJ, Mathur P, Hassan H, Atassi H, Stocker A, Hughes M, McElmurray L, Pinkston C, Abell TL. Nutritional Assessment in Patients after Gastric Electrical Stimulation (GES). J Clin Gastroenterol. 2024 Feb 1;58(2):136-142. doi: 10.1097/MCG.0000000000001826. |
| 35183451 | Derived | Shine A, Mathur P, Ahmed S, Ramos S, McElmurray L, Stocker A, Pinkston C, Abell TL. Low-Resolution Electrogastrogram at Baseline and Response to Temporary Gastric Electrical Stimulation-A Comparison of Cutaneous With Mucosal Recordings. Neuromodulation. 2022 Dec;25(8):1150-1159. doi: 10.1016/j.neurom.2021.12.008. Epub 2022 Feb 17. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007132 |
| Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D005743 | Gastrectomy |
| D000074433 | Myotomy |