Pancreatitis Acute BiliaryEEPAB2NCT00987428
Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis
A study testing ultrasonography with or not sphincterotomy and Usual procedure in people with Pancreatitis Acute Biliary, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis Acute Biliary
- What is being tested?
- ultrasonography with or not sphincterotomy and Usual procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2009to Mar 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18
- predicted severe acute biliary pancreatitis (including age > 80, BMI >30, pre-existing organ failure, Modified Glasgow score > 3)
- timespan between onset and randomization < 48 hrs
- informed consent signed by patient or liable person in case of emergency
Who cannot join
- non biliary pancreatitis
- non severe pancreatitis
- age < 18
- timespan between onset and randomization > 48 hrs
- absence of consent
- ongoing pregnancy
- no social security insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Multicenter Trial of Early EUS Followed by Endoscopic Sphincterotomy in Case of Bile Duct Stone vs Conservative Treatment in Severe Biliary Pancreatitis
The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP).
Read the detailed description
The management of Acute biliary pancreatitis (ABP) remains controversial. Although early decompression of the bile duct is deemed potentially beneficial, previous randomised studies failed to show the benefit of early endoscopic sphincterotomy (ES) except in selected cases. However, those studies did not use recent non invasive diagnostic methods such as EUS.
Methodology: Patients in the study group undergo EUS followed by ES in case of common bile duct stones within 48 hours of the onset pf symptoms; The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.
- Conditions
- Pancreatitis Acute Biliary
- Being tested
- ultrasonography with or not sphincterotomy, Usual procedure
- Keywords
- ERCP, EUS, Pancreatitis biliary, Severe, Interventional endoscopy, Choledocolithiasis
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonography with or not sphincterotomyProcedure or surgery
Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
Usual procedureProcedure or surgery
The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.
| Study group | Role | What they receive |
|---|---|---|
| groupe 1 | Experimental | Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone Receives: Procedure: ultrasonography with or not sphincterotomy |
| Groupe 2 | Active comparator | usual procedure Receives: Procedure: Usual procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the SOFA score measured at entry in the study (day 0) and at day 8
Measured: Day 8
Secondary outcomes (5)
Differences in SOFA score as measured at entry in the study and at day 15
Measured: Day 15
Procedure-related morbidity
Measured: at Day 15 to 3 months
Overall morbidity
Measured: at day 15
Overall mortality
Measured: at day 15
Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15
Measured: at day 8 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2011
- Study completionMar 2012
Why it stopped: Insufficient number of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis Acute BiliaryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Frederic Prat, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987428
- Sponsor's protocol ID
- P080903
- Acronym
- EEPAB2
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2009
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Multicenter Trial of Early EUS Followed by Endoscopic Sphincterotomy in Case of Bile Duct Stone vs Conservative Treatment in Severe Biliary Pancreatitis
- ClinicalTrials.gov ID
- NCT00987428
- Acronym / sponsor ID
- EEPAB2 / P080903
- Conditions
- Pancreatitis Acute Biliary
- Keywords
- ERCP, EUS, Pancreatitis biliary, Severe, Interventional endoscopy, Choledocolithiasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient number of participants
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Aug 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Oct 2009 (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.
The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP).
Detailed description
The management of Acute biliary pancreatitis (ABP) remains controversial. Although early decompression of the bile duct is deemed potentially beneficial, previous randomised studies failed to show the benefit of early endoscopic sphincterotomy (ES) except in selected cases. However, those studies did not use recent non invasive diagnostic methods such as EUS.
Methodology: Patients in the study group undergo EUS followed by ES in case of common bile duct stones within 48 hours of the onset pf symptoms; The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| groupe 1 | Experimental | Procedure: ultrasonography with or not sphincterotomyEarly endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone |
| Groupe 2 | Active comparator | Procedure: Usual procedureusual procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18
- predicted severe acute biliary pancreatitis (including age > 80, BMI >30, pre-existing organ failure, Modified Glasgow score > 3)
- timespan between onset and randomization < 48 hrs
- informed consent signed by patient or liable person in case of emergency
Key exclusion criteria (7 listed)
- non biliary pancreatitis
- non severe pancreatitis
- age < 18
- timespan between onset and randomization > 48 hrs
- absence of consent
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 |
|---|---|---|
| ultrasonography with or not sphincterotomyEarly endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone | Procedure or surgery | groupe 1 |
| Usual procedureThe control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction. | Procedure or surgery | Groupe 2 |
Primary outcome
The difference between the SOFA score measured at entry in the study (day 0) and at day 8
Time frame: Day 8
5 secondary outcomes
Differences in SOFA score as measured at entry in the study and at day 15
Time frame: Day 15
Procedure-related morbidity
Time frame: at Day 15 to 3 months
Overall morbidity
Time frame: at day 15
Overall mortality
Time frame: at day 15
Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15
Time frame: at day 8 and day 15
Results and safety
The study was stopped early (reason given: Insufficient number of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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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.
Frederic Prat, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonography with or not sphincterotomy and Usual procedure in people with Pancreatitis Acute Biliary, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Nov 2025. 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 France. 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 was stopped early (reason given: Insufficient number of participants). Results are not available in the source record.
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?
The difference between the SOFA score measured at entry in the study (day 0) and at day 8 (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.