The Effect of 100mg Aspirin on Recurrent Acute Pancreatitis: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- The mean interval between two consecutive occurrences of acute pancreatitis during follow-up
研究概览
简要总结
Recurrent acute pancreatitis (RAP) was defined as two or more occurrences of acute pancreatitis, which was associated with higher percentages of morbidities and mortalities, lower patients' life quality and increased health-care costs. Current interventions, including cholecystectomy and abstain from drinking were reported to be effective methods for preventing the recurrences of biliary and alcoholic etiologies, respectively. However, there were no effective preventions for other etiologies, such as idiopathic etiologies. Non-steroid anti-inflammatory drugs (NSAIDs), including indomethacin, diclofenac and aspirin could inhibiting the inflammatory cascade of pancreatitis. In this study, we aimed at exploring the effects of 100mg aspirin on reducing the occurrences of recurrent acute pancreatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with with recurrent acute pancreatitis
排除标准
- •Less than 2 episodes of acute pancreatitis in the past year
- •Latrogenic AP (pancreatitis due to endoscopic retrograde cholangiopancreatography, surgery, or after other invasive treatment). Iatrogenic pancreatitis will not count as an episode of recurrent pancreatitis
- •Previous allergy to Non-Steroid Anti-inflammatory Drugs (NSAIDs)
- •Regularly taking aspirin or other NSAIDs >3 doses per week
- •Contradictions for the medications of NSAIDs, including Active peptic ulcer disease or gastrointestinal hemorrhage within 3 months or previous peptic ulcer, history of significant hepatic or renal disease, platelet count less than 100X10^9/L or international normalized ratio (INR) >1.5)
- •Biliary stones
- •Receiving endoscopic sphincterotomy and/or pancreatic stent placement and/or cholecystectomy and/or pancreatic surgery after the latest pancreatitis or planning to undergo one of those interventions within preceding 2 years
- •Patients with the level of serum triglycerides of >5.65 mmol/L and did not receive regular lipid-lowering therapy
- •Primary hyperparathyroidism has been well-treated after last episode of pancreatitis and recruitment or will be operated in <2 years
- •Patients with previously heavy alcohol consumption (50g/day for men, 40g/day for women) and have not quit drinking, or have significant withdrawal symptoms
- •Pregnant or breastfeeding patients
- •Inability to give informed consents
研究组 & 干预措施
100mg aspirin group
Patients received oral 100mg aspirin, one tablet daily for 2 years
干预措施: 100mg aspirin (Drug)
结局指标
主要结局
The mean interval between two consecutive occurrences of acute pancreatitis during follow-up
时间窗: 2 years
Acute pancreatitis was defined as meeting two or three following items: (1) acute onset of a persistent, severe, epigastric pain often radiating to the back. (2) Serum amylase and/or lipase concentrations at least three times higher than upper limit of normal value. (3) Abdominal imaging examination results showed pancreatic inflammation.
次要结局
- The numbers of acute pancreatitis during follow-up(2 years)
- The numbers of pancreatitis with different severity evaluated by revised Atlanta criteria(2 years)
- The hospitalization days due to acute pancreatitis(2 years)
- The rate of patients with chronic pancreatitis.(2 years)
- The rate of patients with new-onset diabetes(2 years)
- The numbers of aspirin tablets the patients actually take(2 years)
- The mortality rate(2 years)
- The rate of patients who had adverse events due to oral aspirin(2 years)
研究者
Yanglin Pan
Professor
Air Force Military Medical University, China