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Chronic use of statins and risk of post-ERCP acute pancreatitis (STARK) : Study protocol for an international multicenter prospective cohort study
- Source :
- DIGESTIVE AND LIVER DISEASE, r-FISABIO. Repositorio Institucional de Producción Científica, instname, r-FISABIO: Repositorio Institucional de Producción Científica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO), r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante, Digestive and Liver Disease, Volume 50, Issue 12
- Publication Year :
- 2018
-
Abstract
- Background: Acute pancreatitis (AP) is the most common complication after endoscopic retrograde cholangiopancreatography (ERCP). Statins have been traditionally associated to an increased risk of AP, however, recent evidence suggests that statins may have a protective role against this disease. Aims: Our primary aim is to investigate whether the use of statins has a protective effect against post-ERCP pancreatitis (PEP). Secondary outcomes are: to evaluate the effect of other drugs on the incidence of PEP; to ascertain the relationship between the use of statins and the severity of PEP; and to evaluate the effect of other risk and protective factors on the incidence of PEP. Methods: STARK is an international multicenter prospective cohort study. Centers from Spain, Italy, Croatia, Finland and Sweden joined this study. The total sample size will include about 1016 patients, which was based on assuming a 5% incidence of PEP among non-statin (NSt) users, a 1-3 ratio of statin (St) and NSt consumers respectively, a 70% decrease in PEP among St consumers, an alpha-error of 0.05 and beta-error of 0.20. All patients aged >18 years scheduled for ERCP will be offered to enter the study. Discussion: STARK study will ascertain whether statins, a safe, widely used and inexpensive drug, can modify the incidence of PEP. (C) 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
- Subjects :
- Male
Internationality
Disease
Hydroxymethylglutaryl-CoA reductase inhibitors
0302 clinical medicine
Risk Factors
Endoscopic retrograde cholangiopancreatography
Multicenter Studies as Topic
Prospective Studies
Prospective cohort study
BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Interna medicina
Cholangiopancreatography, Endoscopic Retrograde
medicine.diagnostic_test
Incidence (epidemiology)
Data Collection
Incidence
Gastroenterology
3. Good health
Europe
030220 oncology & carcinogenesis
Acute Disease
cardiovascular system
Acute pancreatitis
030211 gastroenterology & hepatology
Female
medicine.medical_specialty
Statin
medicine.drug_class
education
03 medical and health sciences
ERCP
Internal medicine
medicine
Humans
Prevention
Prophylaxis
BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Internal Medicine
METAANALYSIS
Hepatology
business.industry
Protective Factors
medicine.disease
3126 Surgery, anesthesiology, intensive care, radiology
Logistic Models
Pancreatitis
3121 General medicine, internal medicine and other clinical medicine
business
Complication
Subjects
Details
- Language :
- English
- ISSN :
- 15908658
- Database :
- OpenAIRE
- Journal :
- DIGESTIVE AND LIVER DISEASE, r-FISABIO. Repositorio Institucional de Producción Científica, instname, r-FISABIO: Repositorio Institucional de Producción Científica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO), r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante, Digestive and Liver Disease, Volume 50, Issue 12
- Accession number :
- edsair.doi.dedup.....71f2660152dcee5ee9d81d602cc4468c