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Идёт набор NCT06185621

The Effect of Aspirin on Recurrent Acute Pancreatitis

Без фазы С лечением Recurrent Acute Pancreatitis Prevention Aspirin

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 100mg aspirin.
Кому может быть актуально
Состояния в реестре: Recurrent Acute Pancreatitis, Prevention, Aspirin. Базовые параметры: 14 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • Patients with with recurrent acute pancreatitis

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Air Force Military Medical University, China — Сиань

Публикации

  • 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

Идентификаторы

NCT: NCT06185621 · KY20232303-F-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗