The Effect of Aspirin on Recurrent Acute Pancreatitis

NCT06185621 | Recruiting

• 1 other identifier: KY20232303-F-1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Acute Pancreatitis; Prevention; Aspirin

Outcome Measures

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.

  2 years

Secondary Outcomes (8)

• The numbers of acute pancreatitis during follow-up

  2 years

• The numbers of pancreatitis with different severity evaluated by revised Atlanta criteria

  2 years

• The hospitalization days due to acute pancreatitis

  2 years

• The rate of patients with chronic pancreatitis.

  2 years

• The rate of patients with new-onset diabetes

  2 years

Study Arms (1)

100mg aspirin group

EXPERIMENTAL

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

Drug: 100mg aspirin

Interventions

100mg aspirin DRUG

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

100mg aspirin group

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with with recurrent acute pancreatitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Air Force Military Medical University, China

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Yanglin Pan, MD

CONTACT

+8613991811225; yanglinpan@hotmail.com

Xiaoyu Kang, MD

CONTACT

+8615291680602; kangxiaoyu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

CN (1)