Early EUS in Acute Biliary Pancreatitis

April 29, 2015 updated by: Michele Tedeschi, Istituto Clinico Humanitas

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
181

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rozzano, Milan, Italy, 20089
        • Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other Names:
  • Olympus 180 series(Olympus Europa Holding, Hamburg, Germany)
Device: Olympus 180 series echoendoscope

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Twenty-four hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Clinico Humanitas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea Anderloni, MD, PhD, Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, 20089, Italy

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EARLY-EUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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