Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
181 participants
INTERVENTIONAL
2010-01-31
2013-06-30
Brief Summary
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In clinical practice the decision to perform an ERCP is often based on biochemical and radiological criteria despite they already have been shown to be unreliable predictors of CBD stone presence.
Endoscopic ultrasound (EUS) is not currently a worldwide standard diagnostic procedure early in the course of acute biliary pancreatitis, but it has been shown to be accurate, safe and cost effective in diagnosing biliary obstructions compared with magnetic resonance cholangiopancreatography (MRCP) and ERCP and therefore in preventing unnecessary ERCP and its related complications.
The investigators aim to investigate the clinical usefulness of early EUS in the management of ABP.
All consecutive patients entering the emergency department due to acute abdominal pain and showing biochemical and/or radiological findings consistent with possible ABP will be prospectively enrolled. Patients will be classified as having a low, moderate, or high probability of CBD stones, according to established risk stratification. All enrolled patients will undergo EUS within 48 h of their admission. ERCP will be performed immediately after EUS only in those cases with proven CBD stones or sludge.
The following parameters will be investigated: (1) clinical: age, sex, fever; (2) radiological: dilated CBD, (3) biochemical: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (gGT), alkaline phosphatase (ALP), amylase, lipases, C-reactive protein (CRP). Association between presence of CBD stone at EUS and the individual predictors were assessed by univariate logistic regression. Predictors significantly associated with CBD stones (p\<0.05) will enter in a multivariate logistic regression model.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Endoscopic Ultrasound
All consecutive patients entering the emergency department due to acute abdominal pain and showing biochemical and/or radiological findings consistent with possible acute biliary pancreatitis, undergo Endoscopic Ultrasound with linear array Olympus 180 series echoendoscopes (Olympus Europa Holding, Hamburg, Germany).
Endoscopic Ultrasound
Endoscopic Ultrasound
Olympus 180 series echoendoscope
Interventions
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Endoscopic Ultrasound
Endoscopic Ultrasound
Olympus 180 series echoendoscope
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patient in whom the cause of biliary obstruction was already identified by US
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Michele Tedeschi
Chief of Clinical Research
Principal Investigators
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Andrea Anderloni, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, 20089, Italy
Locations
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Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milan, Italy, Italy
Countries
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References
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Fabbri C, Polifemo AM, Luigiano C, Cennamo V, Fuccio L, Billi P, Maimone A, Ghersi S, Macchia S, Mwangemi C, Consolo P, Zirilli A, Eusebi LH, D'Imperio N. Single session versus separate session endoscopic ultrasonography plus endoscopic retrograde cholangiography in patients with low to moderate risk for choledocholithiasis. J Gastroenterol Hepatol. 2009 Jun;24(6):1107-12. doi: 10.1111/j.1440-1746.2009.05828.x.
ASGE Standards of Practice Committee; Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. No abstract available.
De Lisi S, Leandro G, Buscarini E. Endoscopic ultrasonography versus endoscopic retrograde cholangiopancreatography in acute biliary pancreatitis: a systematic review. Eur J Gastroenterol Hepatol. 2011 May;23(5):367-74. doi: 10.1097/MEG.0b013e3283460129.
Anderloni A, Galeazzi M, Ballare M, Pagliarulo M, Orsello M, Del Piano M, Repici A. Early endoscopic ultrasonography in acute biliary pancreatitis: A prospective pilot study. World J Gastroenterol. 2015 Sep 28;21(36):10427-34. doi: 10.3748/wjg.v21.i36.10427.
Other Identifiers
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EARLY-EUS
Identifier Type: -
Identifier Source: org_study_id