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临床试验/NCT01173484
NCT01173484终止不适用

Idiopathic Gastroparesis Registry to Define Severity, Treatment Response, and Prognosis Using a Predominant-Symptom Classification

University of Louisville1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
1
主要终点
Incidence of poor outcome

研究概览

简要总结

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 differences in causes, symptoms, and prognosis among patients with idiopathic gastroparesis. Understanding these differences is necessary in order to provide effective treatment in these patients. We believe our classification for gastroparesis is a useful tool in the management of patients with idiopathic gastroparesis to predict clinical severity, treatment response, and future prognosis.

详细描述

"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 gastroparesis. 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 differences in pathophysiology, clinical presentation, severity, and future prognosis among patients with idiopathic gastroparesis. Understanding these differences is necessary in order to provide cost-effective treatment in these patients.

We believe our clinical classification for gastroparesis is a clinical useful tool in the management of patients with idiopathic gastroparesis to predict clinical severity, treatment response, and future prognosis. Patients with vomiting-predominant gastroparesis will be more likely to have an underlying cause, such as viral infection or impaired glucose tolerance with vagal neuropathy. Their symptoms will likely be persistent. Patients with dyspepsia-predominant gastroparesis mimic those with functional dyspepsia and are unlikely to have complications such as weight loss, and dehydration. The necessity of enteric feeding in these patients is also unlikely. Prokinetics may help since delayed gastric emptying may contribute to epigastric pain or postprandial distress. Finding and treating small intestinal bacterial overgrowth as well as suggesting lifestyle and dietary modifications may be helpful. Patients with regurgitation-predominant gastroparesis may benefit most by improving their delayed gastric emptying. Their gastroparesis may cause reflux-like symptoms, especially at night.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Incidence of poor outcome

时间窗: 3 years

Compare the incidence of any one of the following indicators of poor outcome between subjects with vomiting-predominant, dyspepsia-predominant, and regurgitation-predominant idiopathic gastroparesis: i) Developing new weight loss of \>10% due to gastroparesis compare to weight at study baseline ii) Gastric failure (severe symptoms requiring G or J tube or TPN) iii) Death

次要结局

  • Prevalence of obesity, metabolic syndrome and impaired glucose tolerance(1 year)
  • Clinical severity(1 year)
  • Incidence of treatment success(3 years)
  • Potential etiology of "idiopathic" gastroparesis(1 year)
  • Prognostic indicators for idiopathic gastroparesis(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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