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The Effect of Aspirin on Recurrent Acute Pancreatitis

NCT ID: NCT06185621

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrent Acute Pancreatitis Prevention Aspirin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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100mg aspirin group

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

Group Type EXPERIMENTAL

100mg aspirin

Intervention Type DRUG

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

Interventions

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100mg aspirin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Air Force Military Medical University, China

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanglin Pan, MD

Role: CONTACT

Phone: +8613991811225

Email: [email protected]

Xiaoyu Kang, MD

Role: CONTACT

Phone: +8615291680602

Email: [email protected]

Facility Contacts

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Yanglin Pan, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26299411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29894415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15489888 (View on PubMed)

Other Identifiers

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KY20232303-F-1

Identifier Type: -

Identifier Source: org_study_id