Early EUS in Acute Biliary Pancreatitis
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Istituto Clinico Humanitas
临床试验: NCT02430285
BioSeek: nct02430285
关键词
抽象
Acute biliary pancreatitis (ABP) is a potentially life-threatening condition caused by common bile duct (CBD) stones or sludge, which requires prompt diagnosis and treatment by endoscopic removal of the material. Accurate detection of CBD stones is warranted to select patients for early therapeutic endoscopic retrograde cholangiopancreatography (ERCP).
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.
日期
最后验证: | 03/31/2015 |
首次提交: | 04/06/2015 |
提交的预估入学人数: | 04/28/2015 |
首次发布: | 04/29/2015 |
上次提交的更新: | 04/28/2015 |
最近更新发布: | 04/29/2015 |
实际学习开始日期: | 12/31/2009 |
预计主要完成日期: | 06/30/2012 |
预计完成日期: | 05/31/2013 |
状况或疾病
Acute Biliary Pancreatitis
干预/治疗
Procedure: Endoscopic Ultrasound
Device: Endoscopic Ultrasound
相
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手臂组
臂 | 干预/治疗 |
---|---|
Other: 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). | Procedure: Endoscopic Ultrasound Endoscopic Ultrasound |
资格标准
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - All consecutive patients entering the emergency department for possible acute biliary pancreatitis Exclusion Criteria: - gastrectomy - patient in whom the cause of biliary obstruction was already identified by US |
结果
主要结果指标
1. Reliability of early EUS [Twenty-four hours]
Accuracy of EUS in detecting CBD stones (percentage of detection of choledocholithiasis with an early EUS approach in all patients with ABP)