Clinical trial NCT06185621: The Effect of Aspirin on Recurrent Acute Pancreatitis
Official title: The Effect of 100mg Aspirin on Recurrent Acute Pancreatitis: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Acute Pancreatitis
Prevention
Aspirin
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 23
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients received oral 100mg aspirin, one tablet daily for 2 years
Primary purpose: PREVENTION

Brief summary: 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: 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

Primary outcomes:
measure: The mean interval between two consecutive occurrences of acute pancreatitis during follow-up
timeFrame: 2 years
Secondary outcomes:
measure: The numbers of acute pancreatitis during follow-up
timeFrame: 2 years
measure: The numbers of pancreatitis with different severity evaluated by revised Atlanta criteria
timeFrame: 2 years
measure: The hospitalization days due to acute pancreatitis
timeFrame: 2 years
measure: The rate of patients with chronic pancreatitis.
timeFrame: 2 years
measure: The rate of patients with new-onset diabetes
timeFrame: 2 years
measure: The numbers of aspirin tablets the patients actually take
timeFrame: 2 years
measure: The mortality rate
timeFrame: 2 years
measure: The rate of patients who had adverse events due to oral aspirin
timeFrame: 2 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Air Force Military Medical University, China
state: Shaanxi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.