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The Effect of Aspirin on Recurrent Acute Pancreatitis

ConditionsRecurrent Acute PancreatitisPreventionAspirin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-80
SponsorAir Force Military Medical University, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with with recurrent acute pancreatitis

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 100mg aspirin

    Drug

    Patients received oral 100mg aspirin, one tablet daily for 2 years

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: 100mg aspirin groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

The numbers of acute pancreatitis during follow-up

Time frame
2 years
2

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).

Time frame
2 years
3

The hospitalization days due to acute pancreatitis

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

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Air Force Military Medical University, China

Lead sponsor

Source ClinicalTrials.gov
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