Gastrointestinal endoscopy · 2003
Does prophylactic administration of corticosteroid reduce the risk and severity of post-ERCP pancreatitis: a randomized, prospective, multicenter study.
Клиническое исследованиеСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Sherman Stuart, Blaut Urszula, Watkins James L, Barnett Jeffrey, Freeman Martin, Geenen Joseph, Ryan Michael, Parker Harrison, Frakes James T, Fogel Evan L, Silverman William B, Dua Kulwinder S, Aliperti Giuseppe, Yakshe Paul, Uzer Michael, Jones Whitney, Goff John, Earle Dee, Temkit M'hamed, Lehman Glen A
Аннотация
BACKGROUND: Pancreatitis is the most common major complication of diagnostic and therapeutic ERCP. There have been continuing efforts to identify a pharmacologic agent capable of reducing the frequency and severity of this complication. On the basis of several case reports, experimental data, and knowledge of their mechanism of action, corticosteroids might be effective in this regard. The aim of this randomized, double-blind, controlled trial was to determine whether prophylactic, orally administered corticosteroid reduces the frequency and/or severity of post-ERCP pancreatitis.
METHODS: A total of 1115 patients were randomized to receive either prednisone (40 mg) or a placebo orally 15 hours and 3 hours before ERCP. A 160 variable database was prospectively collected according to a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis.
RESULTS: The overall frequency of pancreatitis was 15.07%. It occurred in 92 of 555 patients in the corticosteroid group (16.6%), and in 76 of 560 patients in the control group (13.6%; p = 0.19). The pancreatitis was mild in 10.04%, moderate in 4.04%, and severe in 0.99%. There was no difference between the groups with regard to the severity of pancreatitis. Moreover, the groups were similar with regard to age, gender, body mass index, frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of pre-cut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi dysfunction, sphincter of Oddi manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and bile duct diameter.
CONCLUSION: Prophylactic orally administered corticosteroid did not reduce the frequency or severity of post-ERCP pancreatitis.
METHODS: A total of 1115 patients were randomized to receive either prednisone (40 mg) or a placebo orally 15 hours and 3 hours before ERCP. A 160 variable database was prospectively collected according to a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis.
RESULTS: The overall frequency of pancreatitis was 15.07%. It occurred in 92 of 555 patients in the corticosteroid group (16.6%), and in 76 of 560 patients in the control group (13.6%; p = 0.19). The pancreatitis was mild in 10.04%, moderate in 4.04%, and severe in 0.99%. There was no difference between the groups with regard to the severity of pancreatitis. Moreover, the groups were similar with regard to age, gender, body mass index, frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of pre-cut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi dysfunction, sphincter of Oddi manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and bile duct diameter.
CONCLUSION: Prophylactic orally administered corticosteroid did not reduce the frequency or severity of post-ERCP pancreatitis.
Предметные рубрики MeSH
Administration, OralAdultAge DistributionAgedChi-Square DistributionCholangiopancreatography, Endoscopic RetrogradeDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansIncidenceMaleMiddle AgedPancreatic DiseasesPancreatitisPrednisonePrimary PreventionProbabilityProspective StudiesReference ValuesRisk AssessmentSeverity of Illness Index