Clinical trial NCT00398801: Gastroparesis Registry
Official title: Gastroparesis Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroparesis
Keywords: gastroparesis
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-11-14
Enrollment: 591
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary care centers for patients with symptoms of gastroparesis

Brief summary: The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.

Detailed description: The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis. The Gastroparesis Registry will also provide a resource to inform the development of clinical trials and ancillary studies of the epidemiology, etiology, pathophysiology, and impact of gastroparesis.

Eligibility criteria: Inclusion Criteria:

* Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, abdominal pain, early satiety, post-prandial fullness,
* Completion of a 4-hour scintigraphic low fat Egg Beaters gastric emptying study
* Patients with either or both abnormal 2 hour (\>60% retention) and 4 hour (\>10% retention) gastric emptying will be enrolled and classified as definite gastroparesis (Gp)
* Patients with normal gastric emptying, but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying (GLNGE)
* Age at least 18 years at initial screening visit
* Ability and willingness to participate in follow-up

Exclusion Criteria:

* Inability to comply with or complete the gastric emptying scintigraphy
* Presence of other conditions that could explain the patient's symptoms:
* Pyloric or intestinal obstruction
* Active inflammatory bowel disease
* Eosinophilic gastroenteritis
* Neurological conditions such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
* Acute liver failure
* Advanced liver disease (Child's B or C)
* Acute renal failure
* Untreated chronic renal failure (serum creatinine \>3 mg/dL)
* Total or subtotal gastric resection (patients with prior fundoplication or postvagotomy gastroparesis after pyloroplasty or antrectomy with Billroth I, Billroth II, or Roux-en-Y gastrojejunostomy 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: El Paso
country: United States
facility: Texas Tech University Health Science Center (TTUHSC)
state: Texas
Study officials:
affiliation: Johns Hopkins University Bloomberg School of Public Health
name: James Tonascia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University Hospital
name: Henry P Parkman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: William L Hasler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mississippi Medical Center
name: Thomas L Abell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Pankaj J Pasricha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Kenneth L Koch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University Health Science Center
name: Richard W McCallum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Calles J, Abell TL, Sarosiek I, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F. Cholecystectomy and clinical presentations of gastroparesis. Dig Dis Sci. 2013 Apr;58(4):1062-73. doi: 10.1007/s10620-013-2596-y. Epub 2013 Mar 2.
citation: Sarosiek I, Van Natta M, Parkman HP, Abell T, Koch KL, Kuo B, Shulman RJ, Farrugia G, Grover M, Hamilton FA, Pasricha PJ, Yates KP, Miriel L, Wilson L, Yamada G, Tonascia J, McCallum RW; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Gastroparesis Clinical Research Consortium (GpCRC). Effect of Domperidone Therapy on Gastroparesis Symptoms: Results of a Dynamic Cohort Study by NIDDK Gastroparesis Consortium. Clin Gastroenterol Hepatol. 2022 Mar;20(3):e452-e464. doi: 10.1016/j.cgh.2021.05.063. Epub 2021 Jun 2.
citation: Pasricha PJ, Grover M, Yates KP, Abell TL, Bernard CE, Koch KL, McCallum RW, Sarosiek I, Kuo B, Bulat R, Chen J, Shulman RJ, Lee L, Tonascia J, Miriel LA, Hamilton F, Farrugia G, Parkman HP; National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health Gastroparesis Clinical Research Consortium. Functional Dyspepsia and Gastroparesis in Tertiary Care are Interchangeable Syndromes With Common Clinical and Pathologic Features. Gastroenterology. 2021 May;160(6):2006-2017. doi: 10.1053/j.gastro.2021.01.230. Epub 2021 Feb 3.
citation: Parkman HP, Wilson LA, Yates KP, Koch KL, Abell TL, McCallum RW, Sarosiek I, Kuo B, Malik Z, Schey R, Shulman RJ, Grover M, Farrugia G, Miriel L, Tonascia J, Hamilton F, Pasricha PJ; NIDDK/NIH Clinical Gastroparesis Consortium. Factors that contribute to the impairment of quality of life in gastroparesis. Neurogastroenterol Motil. 2021 Aug;33(8):e14087. doi: 10.1111/nmo.14087. Epub 2021 Jan 25.
citation: Pasricha PJ, Yates KP, Nguyen L, Clarke J, Abell TL, Farrugia G, Hasler WL, Koch KL, Snape WJ, McCallum RW, Sarosiek I, Tonascia J, Miriel LA, Lee L, Hamilton F, Parkman HP. Outcomes and Factors Associated With Reduced Symptoms in Patients With Gastroparesis. Gastroenterology. 2015 Dec;149(7):1762-1774.e4. doi: 10.1053/j.gastro.2015.08.008. Epub 2015 Aug 21.
citation: Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Abell TL, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F; National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium. Clinical features of idiopathic gastroparesis vary with sex, body mass, symptom onset, delay in gastric emptying, and gastroparesis severity. Gastroenterology. 2011 Jan;140(1):101-15. doi: 10.1053/j.gastro.2010.10.015. Epub 2010 Oct 20.