Gastroparesis Outcome Longitudinal Database Enrolled Numerically

Обзор

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.

Подробное описание

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 6. 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

Вмешательства

• Устройство GI Neuromodulation
  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.
• Препарат Immunotherapy
  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; othe
• Процедура Pyloric Therapies
  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; othe

Первичные конечные точки

• Patient Reported Outcome GI Symptoms [Срок оценки: Change from baseline to one week to one year]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• University of Louisville — Louisville

Публикации

• 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. PMID 41307525
• 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. PMID 36626193
• 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. PMID 35183451

Идентификаторы

NCT: NCT03876288 · 20.0697

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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