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NCT Number: NCT06185621

The Effect of Aspirin on Recurrent Acute Pancreatitis

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.

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Key information

Conditions

Recurrent Acute Pancreatitis Aspirin Digestive System Diseases Pancreatic Diseases Pancreatitis Prevention

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Air Force Military Medical University, China

Xi'an, Shaanxi, 710032, China

Location status: Recruiting

Location contact

Yanglin Pan, MD

CONTACT

[email protected]

13991811225

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

100mg aspirin

Drug

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

Primary outcomes

  1. The mean interval between two consecutive occurrences of acute pancreatitis during follow-up

    Time frame: 2 years

    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.

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

    Time frame: 2 years

    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).

  3. The hospitalization days due to acute pancreatitis

    Time frame: 2 years

  4. The rate of patients with chronic pancreatitis.

    Time frame: 2 years

    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.

  5. The rate of patients with new-onset diabetes

    Time frame: 2 years

  6. The numbers of aspirin tablets the patients actually take

    Time frame: 2 years

  7. The mortality rate

    Time frame: 2 years

  8. The rate of patients who had adverse events due to oral aspirin

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoyu Kang, MD

CONTACT

[email protected]

+8615291680602

Yanglin Pan, MD

CONTACT

[email protected]

+8613991811225

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2023
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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