Chronic use of statins and risk of post-ERCP acute pancreatitis (STARK): Study protocol for an international multicenter prospective cohort study

Published on Dec 1, 2018in Digestive and Liver Disease3.57
· DOI :10.1016/J.DLD.2018.07.042
Taija Korpela4
Estimated H-index: 4
(UH: University of Helsinki),
Karina Cárdenas-Jaén5
Estimated H-index: 5
+ 7 AuthorsEnrique de-Madaria18
Estimated H-index: 18
Sources
Abstract
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.
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Background and Aims Prospective data have shown the benefit of rectal indomethacin (IND) for preventing post-ERCP pancreatitis (PEP). A recent pilot study demonstrated a lower incidence of PEP after an 8-hour lactated Ringer's solution (LR) infusion. The aim of this study was to evaluate the efficacy of IND with or without bolus LR in patients at high-risk for PEP. Methods In this randomized, double-blinded, placebo-controlled trial we assigned patients to standard normal saline solution (NS) + ...
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Cited By4
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OBJECTIVES post-endoscopic retrograde cholangiopancreatography (ERCP) acute pancreatitis (PEP) is a frequent complication of this endoscopic procedure. Chronic statin intake has been linked to lower incidence and severity of acute pancreatitis (AP). Periprocedural rectal administration of non-steroidal anti-inflammatory drugs is protective against PEP, but the role of chronic acetylsalicylic-acid (ASA) treatment is unclear. We aimed to investigate whether statins and chronic ASA intake are assoc...
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#1Ryunosuke HakutaH-Index: 9
#2Yousuke NakaiH-Index: 51
Last. Kazuhiko KoikeH-Index: 91
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GOALS AND BACKGROUND: Endoscopic retrograde cholangiopancreatography is widely utilized to diagnose and treat various pancreaticobiliary diseases, but postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) can be a fatal adverse event. Evidence suggests that statins may exhibit suppressive effects on inflammation in the pancreas. We carried out an observational cohort study to examine the protective effect of statins on PEP. STUDY: We retrospectively identified consecutive patient...
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Three-Hydroxy-3-methyl-glutaryl-coenzyme A (HMG co-A) reductase inhibitors (statins) represent an effective therapeutic tool used worldwide in the treatment of dyslipidemia, and a growing body of e...
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#1Antonio Facciorusso (University of Foggia)H-Index: 19
#2Vincenzo Rosario Buccino (University of Foggia)H-Index: 7
Last. Nicola Muscatiello (University of Foggia)H-Index: 22
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ABSTRACT Background Basic and clinical studies suggest that statins may prevent and even ameliorate acute pancreatitis. The present study was to evaluate whether statin decreases the risk of acute pancreatitis in patients undergoing endoscopic ultrasound-guided fine-needle aspiration of pancreatic cysts. Methods Out of 456 patients with pancreatic cysts referred to our center between 2006 and 2018, 365 were finally included in analyses: 86 were treated with statins and 279 were not at the time o...
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Abstract Background/Objectives Acute Pancreatitis (AP) is one of the leading gastrointestinal conditions requiring hospitalization. It has been suggested that statins could exert a protective role in the natural history of AP; however, their influence is not entirely clear. Our objective was to investigate the relationship between statin intake and AP. Methods Retrospective analysis of a prospective registry of patients diagnosed with AP. Statin intake on admission as well as clinical, analytica...
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