Acute Biliary PancreatitisNCT02430285
Early EUS in Acute Biliary Pancreatitis
A study testing Endoscopic Ultrasound and Olympus 180 series echoendoscope in people with Acute Biliary Pancreatitis, run by Istituto Clinico Humanitas at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Biliary Pancreatitis
- What is being tested?
- Endoscopic Ultrasound and Olympus 180 series echoendoscope
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All consecutive patients entering the emergency department for possible acute biliary pancreatitis
Who cannot join
- gastrectomy
- patient in whom the cause of biliary obstruction was already identified by US
Trial locations and contacts
1 site in 1 country.
Italy1 site
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
About this study
Official title: 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.
Read more
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
- Being tested
- Endoscopic Ultrasound, Olympus 180 series echoendoscope
- Keywords
- biliary stone, cholelithiasis, pancreatitis, EUS, ERCP, early, choledocholithiasis
- Medical subject headings
- Cholecystolithiasis, Cholelithiasis, Pancreatitis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic UltrasoundProcedure or surgery
Also called Olympus 180 series(Olympus Europa Holding, Hamburg, Germany)
Endoscopic Ultrasound
Olympus 180 series echoendoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Endoscopic Ultrasound; Device: Olympus 180 series echoendoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Twenty-four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startJan 2010
- Primary completionJul 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Biliary PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Andrea Anderloni, MD, PhD, Principal investigator, Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, 20089, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430285
- Sponsor's protocol ID
- EARLY-EUS
- Status last verified
- Apr 2015
- First submitted
- 7 Apr 2015
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19638088ASGE 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.
PubMed 20105473De 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.
PubMed 21487299Anderloni 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.
PubMed 26420969
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Endoscopic Ultrasound (EUS) in Acute Biliary Pancreatitis: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT02430285
- Acronym / sponsor ID
- EARLY-EUS
- Conditions
- Acute Biliary Pancreatitis
- Keywords
- biliary stone, cholelithiasis, pancreatitis, EUS, ERCP, early, choledocholithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Ultrasound | Other | Procedure: Endoscopic Ultrasound, Device: Olympus 180 series echoendoscopeAll 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients entering the emergency department for possible acute biliary pancreatitis
Key exclusion criteria (2 listed)
- gastrectomy
- patient in whom the cause of biliary obstruction was already identified by US
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic UltrasoundAlso: Olympus 180 series(Olympus Europa Holding, Hamburg, Germany)Endoscopic Ultrasound | Procedure or surgery | Endoscopic Ultrasound |
| Olympus 180 series echoendoscope | Device | Endoscopic Ultrasound |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Background: PubMed 19638088Fabbri 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.
- Background: PubMed 20105473ASGE 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.
- Background: PubMed 21487299De 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.
- Derived from this study: PubMed 26420969Anderloni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Anderloni, MD, PhD principal investigator
Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, 20089, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Ultrasound and Olympus 180 series echoendoscope in people with Acute Biliary Pancreatitis, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of early EUS (time frame: Twenty-four hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430285, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.