Early EUS in Acute Biliary Pancreatitis

Acute Biliary Pancreatitis Clinical Trial

Official title:

Early Endoscopic Ultrasound (EUS) in Acute Biliary Pancreatitis: a Prospective Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430285
• Other study ID #: EARLY-EUS
• Status: Completed
• Phase: N/A
• First received: April 7, 2015
• Last updated: April 29, 2015
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: April 2015
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: June 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Biliary Pancreatitis
• Pancreatitis

Intervention

Procedure:
• Endoscopic Ultrasound
Endoscopic Ultrasound

Device:
• Olympus 180 series echoendoscope

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital	Rozzano, Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes