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临床试验/NCT06402305
NCT06402305招募中不适用

Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases

Alaa Mohamed Mostafa1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Lipid Profile and Ultrasound Findings in Patients with Pancreaticobiliary Diseases

研究概览

简要总结

Gall stones happen is the most prevalent pathology affecting the biliary system due to its Physiological function of concentration of bile having a prevalence of 10%-15% and an incidence of 1.4% per year in the adult population of developed countries (Halldestam et al,. 2009). Women are more commonly affected by gall stone disease as compared to men (Attili et al,. 1995).

Multiple risk factors responsible for the Gall stone formation include modifiable factors such as lifestyle factors (reduced physical activity, rapid weight loss, fasting, and oral contraceptives (Di Ciaula et al,. 2013); dietary factors (high fat, high cholesterol, high refined carbohydrates, and low fiber ; metabolic syndrome (obesity, diabetes mellitus, dyslipidemia, and hyperinsulinemia (Cuevas et al., 2004).

Among all the above mentioned risk factors, serum lipids are considered to be the most important risk factor involved in the pathogenesis of Gall stone disease (Celika et al,. 2015). Hyperlipidemia is generally characterized by high serum levels of total cholesterol, triglycerides, low density lipoproteins (LDL-C), and low levels of high-density lipoprotein (HDL-C). Some studies have showed a significant association of hyperlipidemia with gall stones especially hypertriglyceridemia and increased LDL-C levels (Rao et al,. 2012).

Acute pancreatitis (AP) is an inflammatory condition of the pancreas that originates within the pancreatic acinar cells and causes pancreatic necrosis, systemic inflammatory response syndrome, and multiple organ failure (Crockett et al,. 2013). According to The revised Atlanta classification system from 2012 ,AP is diagnosed on the basis of two of three criteria-typically belt-like abdominal pain, an elevated serum lipase level three times above the normal threshold, and radiological imaging signs of pancreatitis (Parniczky et al,.2016).

Severe hypertriglyceridemia is a well-known cause of AP. Recent studies have suggested that elevated serum triglyceride and low high-density lipoprotein cholesterol (HDL-C) levels are associated with persistent organ failure in acute pancreatitis (Peng et al,. 2015). With the change of people's diet structure and lifestyle, the incidence and mortality of hypertriglyceridemic AP are increasing year by year and has surpassed alcohol as the second leading cause of AP (Carr et al,. 2016).

Chronic pancreatitis is a syndrome characterized by chronic progressive pancreatic inflammation, fibrosis, and scarring, resulting in damage to and loss of exocrine (acinar), endocrine (islet cells), and ductal cells(Majumder S,. 2016)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with age above 18 years
  • Patients with confirmed diagnosis of gall stones ,acute calcular cholecystitis ,calcular obstructive jaundice ,biliary stricture ,acute and chronic pancreatitis

排除标准

  • Patients with renal failure, hemolytic diseases (hereditary spherocytosis, sickle cell anemia on history and CBC film).
  • Patients on antihyperlipidemic drugs .

结局指标

主要结局

Lipid Profile and Ultrasound Findings in Patients with Pancreaticobiliary Diseases

时间窗: 1 year

* To evaluate the lipid profile and ultrasound findings in biliary diseases * To assess the lipid profile and ultrasound findings in pancreatic diseases

次要结局

未报告次要终点

研究者

发起方
Alaa Mohamed Mostafa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alaa Mohamed Mostafa

Resident in Tropical Medicine and Gastroenterology Department Sohag University Hospital

Sohag University

研究点 (1)

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