The Effect of Aspirin on Recurrent Acute Pancreatitis

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of 100mg Aspirin on Recurrent Acute Pancreatitis: a Prospective Cohort Study

Conditions
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Recurrent Acute Pancreatitis, Prevention, Aspirin

Intervention / Treatment
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* Drug: 100mg aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with with recurrent acute pancreatitis Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Patients received oral 100mg aspirin, one tablet daily for 2 years
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100mg aspirin group<br>Patients received oral 100mg aspirin, one tablet daily for 2 years | Drug: 100mg aspirin<br>* Patients received oral 100mg aspirin, one tablet daily for 2 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean interval between two consecutive occurrences of acute pancreatitis during follow-up | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The numbers of acute pancreatitis during follow-up |  | 2 years | 
| The numbers of pancreatitis with different severity evaluated by revised Atlanta criteria | Mild acute pancreatitis, no organ failure and no local or systemic complications; Moderately severe acute pancreatitis, organ failure that resolves within 48 h (transient organ failure) and/or Local or systemic complications without persistent organ failure. Severe acute pancreatitis, Persistent organ failure (>48 h). | 2 years | 
| The hospitalization days due to acute pancreatitis |  | 2 years | 
| The rate of patients with chronic pancreatitis. | chronic pancreatitis was defined according to the Asia&Pacific consensus report, when meeting one of the following conditions: (1) pancreatic calcification on cross-sectional imaging; (2) pancreatic ductal changes on endoscopic retrograde cholangiopancreatography (ERCP); (3) abnormal pancreatic function test results; (d) confirmed CP on endoscopic ultrasound; and (4) histological evidence of CP. | 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 |