Early EUS in Acute Biliary Pancreatitis
Тільки зареєстровані користувачі можуть перекладати статті
Увійти Зареєструватися
Посилання зберігається в буфері обміну
СтатусЗавершено
Спонсори
Istituto Clinico Humanitas
КЛІНІЧНЕ ДОСЛІДЖЕННЯ: NCT02430285
BioSeek: nct02430285
Ключові слова
Анотація
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.
Дати
Востаннє перевірено: | 03/31/2015 |
Перший поданий: | 04/06/2015 |
Орієнтовна реєстрація подана: | 04/28/2015 |
Опубліковано вперше: | 04/29/2015 |
Останнє оновлення надіслано: | 04/28/2015 |
Останнє оновлення опубліковано: | 04/29/2015 |
Фактична дата початку навчання: | 12/31/2009 |
Розрахункова дата первинного завершення: | 06/30/2012 |
Розрахункова дата завершення дослідження: | 05/31/2013 |
Стан або захворювання
Acute Biliary Pancreatitis
Втручання / лікування
Procedure: Endoscopic Ultrasound
Device: Endoscopic Ultrasound
Фаза
-
Групи рук
Рука | Втручання / лікування |
---|---|
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 |
Критерії прийнятності
Стать, яка підходить для вивчення | All |
Приймає здорових добровольців | Так |
Критерії | 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 |
Результат
Заходи первинного результату
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)