Post-ERCP Acute PancreatitisPEP-PREPARENCT04770857
Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis
An observational study of Post-ERCP Acute Pancreatitis, run by Nicola Frei at 1 site in Switzerland.
Trial summary
Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from < 2% up to 40%. Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- Visual analogue scale
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2021to Aug 2023
- Phase
- Observational
- 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
Study population: All patients scheduled for ERCP for any reason at the study center will be asked for participation.
Who may be able to join
- Age >18 years
- Scheduled for ERCP for any reason
Who cannot join
- Absence of consent
- Language barrier
- No endoscopic advance to the papilla vateri
- Active pancreatitis at the time of the procedure
- Mental disability
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Sankt Gallen
Sankt Gallen, 9007
Nicola Fabian Frei, MD, +41 71 494 99 68, nicolafabian.frei@kssg.ch
About this study
Official title: Evaluation of Post-Post-Endoscopic Retrograde Cholangiopancreaticography Pain (ERCP) as a Predictor for Post-ERCP Pancreatitis
Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from < 2% up to 40%.
Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP.
This study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Visual analogue scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual analogue scaleOther
Post procedural pain assessment using the visual analogue scale (VAS) will be performed in patients undergoing ERCP
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between Pain 1 hour after ERCP
Measured: 1 hour
Secondary outcomes (2)
Predictive value of VAS for PEP Predictive value of VAS for PEP
Measured: 1 hour
Association between VAS level and severity of PEP
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Sep 2021 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionAug 2023 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicola Frei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicola Frei, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770857
- Sponsor's protocol ID
- CTU 19/036
- Acronym
- PEP-PREPARE
- Status last verified
- Jul 2021
- First submitted
- 22 Feb 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-Post-Endoscopic Retrograde Cholangiopancreaticography Pain (ERCP) as a Predictor for Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT04770857
- Acronym / sponsor ID
- PEP-PREPARE / CTU 19/036
- Conditions
- Post-ERCP Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nicola FreiUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 25 Feb 2021 (actual)
- 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.
Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from < 2% up to 40%.
Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP.
This study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for ERCP for any reason at the study center will be asked for participation.
Key inclusion criteria (2 listed)
- Age >18 years
- Scheduled for ERCP for any reason
Key exclusion criteria (5 listed)
- Absence of consent
- Language barrier
- No endoscopic advance to the papilla vateri
- Active pancreatitis at the time of the procedure
- Mental disability
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 |
|---|---|---|
| Visual analogue scalePost procedural pain assessment using the visual analogue scale (VAS) will be performed in patients undergoing ERCP | Other | – |
Primary outcome
Association between Pain 1 hour after ERCP
Time frame: 1 hour
2 secondary outcomes
Predictive value of VAS for PEP Predictive value of VAS for PEP
Time frame: 1 hour
Association between VAS level and severity of PEP
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-ERCP Acute Pancreatitis, run by Nicola Frei at 1 site in Switzerland.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jul 2021. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Fabian Frei, MD (+41 71 494 99 68, nicolafabian.frei@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between Pain 1 hour after ERCP (time frame: 1 hour). 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 29 Jul 2021.