Clinical trial

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

Name
KY20232303-F-1
Description
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.
Trial arms
Trial start
2023-11-01
Estimated PCD
2026-11-01
Trial end
2026-11-01
Status
Recruiting
Treatment
100mg aspirin
Patients received oral 100mg aspirin, one tablet daily for 2 years
Arms:
100mg aspirin group
Size
23
Primary endpoint
The mean interval between two consecutive occurrences of acute pancreatitis during follow-up
2 years
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients received oral 100mg aspirin, one tablet daily for 2 years', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ESTIMATED'}}
Updated at
2023-12-29

1 organization

1 product

3 indications

Product
Aspirin
Indication
Prevention
Indication
Aspirin