Post-ERCP Acute PancreatitisPEPSINCT01673763
Post-ERCP Pancreatitis Prevention by Stent Insertion
A study testing Stent insertion into the main pancreatic duct in people with Post-ERCP Acute Pancreatitis, run by Technical University of Munich at 4 sites in 4 countries.
Trial summary
The presented study is designed to analyze the efficacy of pancreatic stent insertion in patients undergoing ERCP with accidental cannulation of the pancreatic duct. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- Stent insertion into the main pancreatic duct
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2010to Aug 2017
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients undergoing ERCP with unintended cannulation or opifiacation of main pancreatic duct
- age > 17 years
- signed informed consent
Who cannot join
- intention to intervene main pancreatic duct
- age < 18 years
- pregnancy
- absent of signed informed consent
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Belgium1 site
Deptartment of Hepatobiliary Diseases Leuven University Hospitals
Leuven, 3000
Germany1 site
Klinikum rechts der Isar, Technische Universität München
Munich, 81675
Latvia1 site
P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas
Riga, 1002
Russia1 site
First city hospital of emergency care Northern State Medical University
Arkhangelsk, 163045
About this study
Official title: Study to Reduce Incidence of Post-ERCP Pancreatitis by Stent Insertion in the Main Pancreatic Duct After Unintended Cannulation of the Main Pancreatic Duct
The presented study is designed to analyze the efficacy of pancreatic stent insertion in patients undergoing ERCP with accidental cannulation of the pancreatic duct.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Stent insertion into the main pancreatic duct
- Keywords
- ERCP, endoscopy, pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent insertion into the main pancreatic ductDevice
Stent insertion into the main pancreatic duct
| Study group | Role | What they receive |
|---|---|---|
| Stent | Active comparator | Stent insertion into the main pancreatic duct Receives: Device: Stent insertion into the main pancreatic duct |
| No stent | No intervention | No stent insertion into the main pancreatic duct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-ERCP pancreatitis
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startJul 2010
- Primary completionJun 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP Acute 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Northern State University, Russia, KU Leuven, Latvijas Universitates Medicinas
- Responsible party
- Principal investigator, Monther Bajbouj, Technical University of Munich
- Investigators
- Hana Algül, MD, MPH, Principal investigator, II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673763
- Sponsor's protocol ID
- 240179
- Acronym
- PEPSI
- Status last verified
- Oct 2017
- First submitted
- 17 Oct 2011
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Reduce Incidence of Post-ERCP Pancreatitis by Stent Insertion in the Main Pancreatic Duct After Unintended Cannulation of the Main Pancreatic Duct
- ClinicalTrials.gov ID
- NCT01673763
- Acronym / sponsor ID
- PEPSI / 240179
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- ERCP, endoscopy, pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Northern State University, Russia, KU Leuven, Latvijas Universitates Medicinas
- Study start
- Jul 2010 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 28 Aug 2012 (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 presented study is designed to analyze the efficacy of pancreatic stent insertion in patients undergoing ERCP with accidental cannulation of the pancreatic duct.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent | Active comparator | Device: Stent insertion into the main pancreatic ductStent insertion into the main pancreatic duct |
| No stent | No intervention | –No stent insertion into the main pancreatic duct |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all patients undergoing ERCP with unintended cannulation or opifiacation of main pancreatic duct
- age > 17 years
- signed informed consent
Key exclusion criteria (4 listed)
- intention to intervene main pancreatic duct
- age < 18 years
- pregnancy
- absent of signed informed 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 |
|---|---|---|
| Stent insertion into the main pancreatic ductStent insertion into the main pancreatic duct | Device | Stent |
Primary outcome
Incidence of post-ERCP pancreatitis
Time frame: up to 1 week
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 13 Oct 2017.
Related trials for Post-ERCP Acute Pancreatitis
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Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
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Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
Acute Biliary Pancreatitis
Recruiting
Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Pancreatitis, Acute
RecruitingObservational study
An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Post-ERCP Acute Pancreatitis
Not yet recruitingPhase 4
Indomethacin for Biliary ERCP Patients
Pancreatitis Biliary, Pancreatitis Acute Biliary
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.
Hana Algül, MD, MPH principal investigator
II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent insertion into the main pancreatic duct in people with Post-ERCP Acute Pancreatitis, run by Technical University of Munich at 4 sites in 4 countries.
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 3 inclusion and 4 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Germany, Latvia, Russia. 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?
Incidence of post-ERCP pancreatitis (time frame: up to 1 week). 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 13 Oct 2017.