GpR2GpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveMaladies du système digestif+5
+ Maladies Gastro-intestinales
+ Manifestations Neurologiques
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 1 juillet 2012
Date à laquelle le premier participant a commencé l'étude.The Gastroparesis Registry 2 (GpR 2) will enroll new patients and patients from the initial NIDDK Gastroparesis Clinical Research Consortium Gastroparesis Registry (GpR) of gastroparesis patients which was initiated in February 2007 and completed in March 2011. To continue to follow and expand the data collections of a well-characterized cohort to further define the natural history and clinical course of gastroparesis. To provide a reliable source for recruitment of well-characterized patients with gastroparesis for therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies. These subsequent clinical trials or ancillary studies will be conducted under separate study protocols with separate consent processes.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.506 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, early satiety, post-prandial fullness, and/or abdominal pain * An etiology of either diabetic, idiopathic, or post-Nissen fundoplication gastroparesis * Gastric emptying scintigraphy of solids and liquids test using 4 hours Egg Beaters® protocol within the last 6 months with either: * Abnormal gastric emptying rate defined as an abnormal 2 hour (\>60% retention) and/or 4 hour (\>10% retention) result based on a 4-hour scintigraphic low fat Egg Beaters® gastric emptying study performed at a GpCRC clinical center. * Patients with a normal gastric emptying rate but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying * Age at least 18 years at initial screening visit * Upper endoscopy results within last 2 years Exclusion Criteria: * Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs) * Presence of other conditions that could explain the patient's symptoms: * Pyloric or intestinal obstruction as determined by endoscopy, upper GI series or abdominal CT scan * Active inflammatory bowel disease * Known eosinophilic gastroenteritis * Primary neurological conditions that could cause nausea and/or vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions * Acute liver failure * Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7 ) * Acute renal failure * Chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis * Total or subtotal (near complete) gastric resection, esophagogastrostomy, gastrojejunostomy, or gastric bypass. Note: patients with prior fundoplication will be eligible for enrollment. * Any other plausible structural or metabolic cause * Any other condition, which in the opinion of the investigator would interfere with study requirements * Inability to obtain informed consent
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 6 sites
Johns Hopkins Bayview Medical Center
Baltimore, United StatesMassachusetts General Hospital-Digestive Healthcare Center
Boston, United StatesWake Forest University Health Sciences
Winston-Salem, United States