A Large Sample Follow-up Study of Long-term Complications of Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- change in glucose
研究概览
简要总结
This is a follow-up study focusing on long-term complications of acute pancreatitis. The primary purposes include: 1. To assess the incidence of type 2 diabetes mellitus（2-DM）,impaired glucose tolerance, metabolic abnormalities of blood lipids after acute pancreatitis. 2. To observe the possible long-term clinical outcomes after acute pancreatitis attack, which may include: chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension, autoimmune pancreatitis et al. 3. To evaluate the long-term influence of acute lung injury(PaO2/FiO2<200,FiO2 means fraction of inspiration O2) in AP patients during ICU stay on life qualities of the patients; 4. To observe the prognosis of the local complications of acute pancreatitis(AP) patients; it might be helpful to find the most effective and targeted interventions aiming at different phases after AP attack.
详细描述
Currently，follow-up study is limited on glucose intolerance and life quality assessment. However, it has been shown that AP is associated to some extent with other diseases such as chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension and autoimmune pancreatitis; In addition, for patients who have severe lung injury following AP, especially with PaO2/FiO2<200 during ICU stay, the long term prognosis remains unclear. Thus, a large sample follow-up study is essential for elucidating the possible long-term complications.
Prior to follow up study, the investigators performed baseline analysis of AP patient data from the database of the First Affiliated Hospital of Nanchang University. It is estimated that 1300 patients will be interviewed over telephone and 600 patients in the outpatient department. The content of the follow-up includes: questionnaire (the MOS[medical outcome study] item short from health survey, SF[short form]-36) ; lab testing(complete blood count, blood chemistry such as liver and kidney function, C-reaction protein(CRP), AMY, fasting blood-glucose，1 and 2 hour postprandial blood glucose,C-peptide, blood lipids, FE-1) and CT scan. For patients who have severe lung injuries during ICU stay, pulmonary function test, Blood gas analysis and chest CT will be performed. After screening, the patients with chronic pancreatitis(CP), pancreatic cancer(PC), post Pancreatogenic portal hypertension（PPH） or autoimmune pancreatitis(AIP）will be hospitalized for further therapy.
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute pancreatitis from our hospital
- •Must be signed the informed consent
排除标准
- •Failed to complete the questionnaire survey and the follow-up examination
结局指标
主要结局
change in glucose
时间窗: An expected duration which estimated to be average of 4.2 years
Fasting blood-glucose，1 and 2 hour postprandial blood glucose will be performed in order to diagnose patients with impaired fasting glucose, impaired glucose tolerance and diabetes according to 2006 World Health organization diagnostic criteria.
Change in C-Peptide
时间窗: An expected duration which estimated to be average of 4.2 years
Fasting C-Peptide，1 and 2 hour postprandial C-Peptide will be performed in order to test pancreatic β-cell function.
Change in the Levels of fecal elastase-1
时间窗: An expected duration which estimated to be average of 4.2 years
Fecal elastase-1(FE-1) were used to evaluate exocrine function. Exocrine insufficiency is defines as FE-1 level less than 200 Kg/g
Change in blood liquid
时间窗: An expected duration which estimated to be average of 4.2 years
Blood liquid(triglyceride, cholesterol, low density lipoprotein and high-density lipoprotein) will be tested aiming at evaluating blood liquid metabolism.
次要结局
- the MOS item short from health survey, SF-36(An expected duration which estimated to be average of 4.2 years)
- Abdomen CT(An expected duration which estimated to be average of 4.2 years)
- outpatient clinic and phone questionnaire(An expected duration which estimated to be average of 4.2 years)
研究者
Lingyu Luo
Physician-in-charge
The First Affiliated Hospital of Nanchang University