Status:
TERMINATED
Idiopathic Gastroparesis Registry Using a Predominant-Symptom Classification
Lead Sponsor:
University of Louisville
Conditions:
Gastroparesis
Eligibility:
All Genders
16-80 years
Brief Summary
The diagnosis of "gastroparesis" suggests that delayed gastric emptying is the underlying cause of symptoms, but this description fails to explain the variable presentation. There are fundamental diff...
Detailed Description
"Idiopathic gastroparesis" is a poor term to describe this very heterogeneous syndrome. Pathophysiology may not be "idiopathic," but merely unidentifiable with conventional methods suggested for gastr...
Eligibility Criteria
Inclusion
- Symptoms of gastroparesis (nausea, vomiting, bloating, dyspepsia, early satiety, or effortless regurgitation) \>1 month in duration.
- Abnormal 4-hour gastric emptying scan within the past 3 months.
- Initial investigation, based on the AGA Technical Review for gastroparesis, is non-diagnostic for an underlying cause
Exclusion
- Presence of endocrine or metabolic diseases: type 1 or type 2 diabetes, hypothyroidism, renal failure, adrenal insufficiency.
- Presence of post-surgical gastroparesis: gastric surgery with vagotomy (with or without gastric resection, esophagectomy; surgery without vagotomy (fundoplication, bariatric surgery, heart-lung transplant).
- Presence of neuromuscular diseases: multiple sclerosis, chronic idiopathic demyelinating polyneuropathy, myotonic dystrophy.
- Presence of connective tissue diseases: systemic sclerosis, mixed connective tissue disorder, polymyositis, dermatomyositis, lupus.
- Presence of autonomic diseases: Central (Parkinson, multiple system atrophy, Lewy body disease, brainstem disease) or Peripheral (idiopathic dysautonomia, amyloidosis, immune-mediated disease, vitamin B12 deficiency, mitochondrial disorder, porphyria, hereditary sensory autonomic neuropathy).
- Presence of paraneoplastic syndrome: small cell lung cancer, multiple myeloma, breast cancer, lymphomas, pancreatic cancer.
- Taking dopamine agonists on a daily basis.
- Presence of known viral infection (Epstein-Barr, cytomegalovirus, herpes simplex, rotavirus), Chagas disease.
- Presence of gastric outlet, small bowel or colon mechanical obstruction.
- Presence of gastric electrical stimulator.
- Non-ambulatory patients: bed-ridden, nursing home resident, etc.
- Presence of active cancer or undergoing cancer treatment.
- Less than 16 years old.
- Pregnancy.
- Unable to provide informed consent.
- Prisoners.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01173484
Start Date
June 1 2010
End Date
August 1 2011
Last Update
April 10 2017
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40205