Early EUS in Acute Biliary Pancreatitis

NCT02430285 | Completed DMC

• 1 other identifier: EARLY-EUS
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Biliary Pancreatitis

Keywords

biliary stone; cholelithiasis; pancreatitis; EUS; ERCP; early; choledocholithiasis

Outcome Measures

Primary Outcomes (1)

• 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)

  Twenty-four hours

Study Arms (1)

Endoscopic Ultrasound

OTHER

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; Device: Olympus 180 series echoendoscope

Interventions

Endoscopic Ultrasound PROCEDURE

Endoscopic Ultrasound

Also known as: Olympus 180 series(Olympus Europa Holding, Hamburg, Germany)

Endoscopic Ultrasound

Olympus 180 series echoendoscope DEVICE

Endoscopic Ultrasound

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients entering the emergency department for possible acute biliary pancreatitis

You may not qualify if:

• gastrectomy
• patient in whom the cause of biliary obstruction was already identified by US

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Rozzano, Milan, Italy, 20089, Italy

Location

Related Publications (4)

• 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.

  PMID: 19638088 BACKGROUND

• 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.

  PMID: 20105473 BACKGROUND

• 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.

  PMID: 21487299 BACKGROUND

• 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.

  PMID: 26420969 DERIVED

MeSH Terms

Conditions

Cholecystolithiasis; Cholelithiasis; Pancreatitis; Choledocholithiasis

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Pancreatic Diseases; Common Bile Duct Diseases; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Andrea Anderloni, MD, PhD

  Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, 20089, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Clinical Research

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 30, 2015
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: June 1, 2013
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

IT (1)