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Gastroparesis Registry 3

A legfontosabb adatok

Ki végzi
Johns Hopkins Bloomberg School of Public Health
Hol
Baltimore, Boston, El Paso, Louisville, Philadelphia és Winston-Salem (Egyesült Államok)Mind a 6 helyszín megnézése
Azonosító
Állapot
Befejeződött
Résztvevők
406 fő vett részt
Kezdés
2019. jan. 24.
Befejezés
2024. máj. 13.
A vizsgálat típusa
Megfigyeléses, 6 csoport
A regiszteradat frissítve
2024. május 24.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 21 feltétel megnézéseKevesebb

Ki vehet részt

  • Symptoms of gastroparesis of at least 12 weeks' duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness
  • An etiology of either diabetic, idiopathic, or post-fundoplication (Nissen, Dor, or Toupet) gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying)
  • Gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) 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 gastric emptying study. (This group will comprise ~75% of patients in the registry.)
  • Patients with a normal gastric emptying rate, but who have symptoms of gastroparesis. (This group will comprise ~25% of patients in the registry.)
  • Negative upper endoscopy or upper radiographic GI series within 2 years of registration
  • Age at least 18 years at initial screening visit

Ki nem vehet részt

  • Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy. Note: patients with prior Nissen, Dor, or Toupet fundoplication will be eligible for enrollment
  • Inability to comply with or complete the gastric emptying test by scintigraphy (including allergy to eggs)
  • Presence of other conditions that could explain the patient's symptoms:
  • Active inflammatory bowel disease
  • Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
  • Acute renal failure
  • Acute liver failure
  • Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
  • Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
  • Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
  • Use of narcotic analgesics greater than three days per week
  • Pyloric or intestinal obstruction: by EGD, UGI, or Abdominal CT
  • Known eosinophilic gastroenteritis or eosinophilic esophagitis
  • Inability to obtain informed consent

Helyszínek itt: Egyesült Államok

  • Johns Hopkins Bayview Medical CenterBaltimore, Egyesült ÁllamokNo longer taking part
  • Massachusetts General Hospital-Digestive Healthcare CenterBoston, Egyesült ÁllamokNo longer taking part
  • Texas Tech University Health Science Center (TTUHSC)El Paso, Egyesült ÁllamokNo longer taking part
  • University of LouisvilleLouisville, Egyesült ÁllamokNo longer taking part
  • Temple University HospitalPhiladelphia, Egyesült ÁllamokNo longer taking part
  • Wake Forest University Health SciencesWinston-Salem, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

The purpose of this study is to create a new registry of patients with gastroparesis in order to better understand the characteristics of patients with gastroparesis and follow how their condition changes over time. The data collected may improve the understanding of the condition to enable better diagnosis and treatment.

A vizsgálat 6 csoportja

  • Diabetic

    Participants with a primary etiology of diabetic gastroparesis

  • Idiopathic

    Participants with a primary etiology of idiopathic gastroparesis

  • Post-fundoplication

    Participants with a primary etiology of post-Nissen fundoplication gastroparesis

  • Diabetic with Normal Emptying

    Diabetic participants with symptomatic nausea and vomiting with normal gastric emptying

  • Idiopathic with Normal Emptying

    Idiopathic participants with symptomatic nausea and vomiting with normal gastric emptying

  • Post-fundoplication with Normal Emptying

    Post-fundoplication participants with symptomatic nausea and vomiting with normal gastric emptying

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
The NIDDK Gastroparesis Registry 3: Characterization and Clinical Course of Symptoms and Gastric Emptying in Patients With Symptoms of Gastroparesis
A regiszteradat frissítve
2024. május 24.