TY - JOUR
T1 - Chronic use of statins and risk of post-ERCP acute pancreatitis (STARK)
T2 - Study protocol for an international multicenter prospective cohort study
AU - Korpela, Taija
AU - Cárdenas-Jaén, Karina
AU - Archibugi, Livia
AU - Poropat, Goran
AU - Maisonneuve, Patrick
AU - Arcidiacono, Paolo Giorgio
AU - De Pretis, Nicolò
AU - Löhr, Matthias
AU - Capurso, Gabriele
AU - de-Madaria, Enrique
PY - 2018/12/1
Y1 - 2018/12/1
N2 - 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.
AB - 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.
KW - Endoscopic retrograde cholangiopancreatography
KW - ERCP
KW - Hydroxymethylglutaryl-CoA reductase inhibitors
KW - Prevention
KW - Prophylaxis
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U2 - 10.1016/j.dld.2018.07.042
DO - 10.1016/j.dld.2018.07.042
M3 - Article
C2 - 30224317
AN - SCOPUS:85053184147
VL - 50
SP - 1362
EP - 1365
JO - Digestive and Liver Disease
JF - Digestive and Liver Disease
SN - 1590-8658
IS - 12
ER -