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Early EUS in Acute Biliary Pancreatitis

Primary Purpose

Acute Biliary Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Endoscopic Ultrasound
Olympus 180 series echoendoscope
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Biliary Pancreatitis focused on measuring biliary stone, cholelithiasis, pancreatitis, EUS, ERCP, early, choledocholithiasis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Endoscopic Ultrasound

Arm Description

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).

Outcomes

Primary Outcome Measures

Reliability of early EUS
Accuracy of EUS in detecting CBD stones (percentage of detection of choledocholithiasis with an early EUS approach in all patients with ABP)

Secondary Outcome Measures

Full Information

First Posted
April 7, 2015
Last Updated
April 29, 2015
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02430285
Brief Title
Early EUS in Acute Biliary Pancreatitis
Official Title
Early Endoscopic Ultrasound (EUS) in Acute Biliary Pancreatitis: a Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Biliary Pancreatitis
Keywords
biliary stone, cholelithiasis, pancreatitis, EUS, ERCP, early, choledocholithiasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Ultrasound
Arm Type
Other
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Ultrasound
Other Intervention Name(s)
Olympus 180 series(Olympus Europa Holding, Hamburg, Germany)
Intervention Description
Endoscopic Ultrasound
Intervention Type
Device
Intervention Name(s)
Olympus 180 series echoendoscope
Primary Outcome Measure Information:
Title
Reliability of early EUS
Description
Accuracy of EUS in detecting CBD stones (percentage of detection of choledocholithiasis with an early EUS approach in all patients with ABP)
Time Frame
Twenty-four hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Anderloni, MD, PhD
Organizational Affiliation
Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, 20089, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
City
Rozzano, Milan
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19638088
Citation
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.
Results Reference
background
PubMed Identifier
20105473
Citation
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.
Results Reference
background
PubMed Identifier
21487299
Citation
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.
Results Reference
background
PubMed Identifier
26420969
Citation
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.
Results Reference
derived

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Early EUS in Acute Biliary Pancreatitis

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