Biliary PancreatitisEEPABNCT00505128
Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis
A study testing Endoscopic sphincterotomy in people with Biliary Pancreatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Pancreatitis
- What is being tested?
- Endoscopic sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to Jul 2009
- 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
- Previous medical examination
- Age over 18
- Acute biliary pancreatitis
- Timespan between onset of symptoms and randomization <72h
- No involvement in another clinical study
- Informed consent obtained
Who cannot join
- Non biliary pancreatitis
- Age < 18
- Timespan between onset of symptoms and randomization >72h
- No follow-up possible beyond 3 months after inclusion
- Ongoing pregnancy
- No informed consent
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- No health insurance affiliation
- Involvement in another clinical study
- Incapacity to understand subject information
- Counter indication of MRI examination if echo-endoscopy is not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study
Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.
Read the detailed description
Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.
Main objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography.
Prospective multicenter randomized controlled study with direct patient benefit
- Conditions
- Biliary Pancreatitis
- Being tested
- Endoscopic sphincterotomy
- Keywords
- Biliary pancreatitis, Bile duct stones, EUS Endoscopic UltraSonography, Endoscopic sphincterotomy, ERCP
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sphincterotomyProcedure or surgery
Also called procedure
procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography Receives: Procedure: Endoscopic sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients cured or consolidated as a function of time
Measured: during 12 months
Secondary outcomes (6)
overall morbidity
Measured: during the 36 months
overall mortality
Measured: during the 36 months
endoscopic procedure-related morbidity and mortality
Measured: during the 12months
LOS
Measured: during the 12 months
morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)
Measured: during the 12 months
economic data
Measured: during the 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary PancreatitisStudies 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
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Frederic PRAT, MD,, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505128
- Sponsor's protocol ID
- P051054
- Acronym
- EEPAB
- Status last verified
- May 2007
- First submitted
- 20 Jul 2007
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00505128
- Acronym / sponsor ID
- EEPAB / P051054
- Conditions
- Biliary Pancreatitis
- Keywords
- Biliary pancreatitis, Bile duct stones, EUS Endoscopic UltraSonography, Endoscopic sphincterotomy, ERCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Jul 2007 (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.
Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.
Detailed description
Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.
Main objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography.
Prospective multicenter randomized controlled study with direct patient benefit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Endoscopic sphincterotomyto test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previous medical examination
- Age over 18
- Acute biliary pancreatitis
- Timespan between onset of symptoms and randomization <72h
- No involvement in another clinical study
Key exclusion criteria (10 listed)
- Non biliary pancreatitis
- Age < 18
- Timespan between onset of symptoms and randomization >72h
- No follow-up possible beyond 3 months after inclusion
- Ongoing pregnancy
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 sphincterotomyAlso: procedureprocedure | Procedure or surgery | 1 |
Primary outcome
Percentage of patients cured or consolidated as a function of time
Time frame: during 12 months
6 secondary outcomes
overall morbidity
Time frame: during the 36 months
overall mortality
Time frame: during the 36 months
endoscopic procedure-related morbidity and mortality
Time frame: during the 12months
LOS
Time frame: during the 12 months
morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)
Time frame: during the 12 months
economic data
Time frame: during the 36 months
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 9 May 2011.
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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, 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 Endoscopic sphincterotomy in people with Biliary Pancreatitis, 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 6 inclusion and 10 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 9 May 2011. 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 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?
Percentage of patients cured or consolidated as a function of time (time frame: during 12 months). 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 9 May 2011; AzTrials last refreshed its copy on 8 Nov 2026.