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Recruiting NCT06185621

The Effect of Aspirin on Recurrent Acute Pancreatitis

No phase Interventional Recurrent Acute Pancreatitis Prevention Aspirin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 100mg aspirin.
Who it may be relevant to
Registry conditions: Recurrent Acute Pancreatitis, Prevention, Aspirin. Basic parameters: 14 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • The mean interval between two consecutive occurrences of acute pancreatitis during follow-up [Time frame: 2 years]
Secondary outcome measures (8)
  • The numbers of acute pancreatitis during follow-up [Time frame: 2 years]
  • The numbers of pancreatitis with different severity evaluated by revised Atlanta criteria [Time frame: 2 years]
  • The hospitalization days due to acute pancreatitis [Time frame: 2 years]
  • The rate of patients with chronic pancreatitis. [Time frame: 2 years]
  • The rate of patients with new-onset diabetes [Time frame: 2 years]
  • The numbers of aspirin tablets the patients actually take [Time frame: 2 years]
  • The mortality rate [Time frame: 2 years]
  • The rate of patients who had adverse events due to oral aspirin [Time frame: 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Air Force Military Medical University, China — Xi'an

Publications

  • Sankaran SJ, Xiao AY, Wu LM, Windsor JA, Forsmark CE, Petrov MS. Frequency of progression from acute to chronic pancreatitis and risk factors: a meta-analysis. Gastroenterology. 2015 Nov;149(6):1490-1500.e1. doi: 10.1053/j.gastro.2015.07.066. Epub 2015 Aug 20. PMID 26299411
  • Guda NM, Muddana V, Whitcomb DC, Levy P, Garg P, Cote G, Uc A, Varadarajulu S, Vege SS, Chari ST, Forsmark CE, Yadav D, Reddy DN, Tenner S, Johnson CD, Akisik F, Saluja AK, Lerch MM, Mallery JS, Freeman ML. Recurrent Acute Pancreatitis: International State-of-the-Science Conference With Recommendations. Pancreas. 2018 Jul;47(6):653-666. doi: 10.1097/MPA.0000000000001053. PMID 29894415
  • Takada Y, Bhardwaj A, Potdar P, Aggarwal BB. Nonsteroidal anti-inflammatory agents differ in their ability to suppress NF-kappaB activation, inhibition of expression of cyclooxygenase-2 and cyclin D1, and abrogation of tumor cell proliferation. Oncogene. 2004 Dec 9;23(57):9247-58. doi: 10.1038/sj.onc.1208169. PMID 15489888

Identifiers

NCT: NCT06185621 · KY20232303-F-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗