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Trial record 30 of 1388 for:    bilirubin AND alanine

Early EUS in Acute Biliary Pancreatitis

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ClinicalTrials.gov Identifier: NCT02430285
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Biliary Pancreatitis Procedure: Endoscopic Ultrasound Device: Olympus 180 series echoendoscope Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Endoscopic Ultrasound (EUS) in Acute Biliary Pancreatitis: a Prospective Pilot Study
Study Start Date : January 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Name: Olympus 180 series(Olympus Europa Holding, Hamburg, Germany)

Device: Olympus 180 series echoendoscope



Primary Outcome Measures :
  1. Reliability of early EUS [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430285


Locations
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Italy
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Andrea Anderloni, MD, PhD Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, 20089, Italy

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michele Tedeschi, Chief of Clinical Research, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02430285     History of Changes
Other Study ID Numbers: EARLY-EUS
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015

Keywords provided by Michele Tedeschi, Istituto Clinico Humanitas:
biliary stone
cholelithiasis
pancreatitis
EUS
ERCP
early
choledocholithiasis

Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases