Post-ERCP Acute PancreatitisPredERCPNCT05800626
Prediction of PEP Based on the Appearance of the Major Duodenal Papilla
An observational study of Post-ERCP Acute Pancreatitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial summary
This observational, prospective study aims at evaluating how the occurrence of post-Endoscopic Retrograde CholangioPancreatography (ERCP) acute pancreatitis (PEP) could be influenced by difficult biliary cannulation that might be previously assessed by the morphological appearance of native major papilla in all the… 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?
- Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- How many people
- 1,740 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Apr 2023to 31 Dec 2025
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include all consecutive patients with a native major duodenal papilla undergoing ERCP. Patients that previously underwent ERCP with sphincterotomy will not be included. Patients will be considered enrolled after signing the informed consent form. All patients will be hospitalized for at least 24 hours after ERCP for clinical observation.
Who may be able to join
- Patients with native duodenal papilla;
- Any indication to ERCP +/- biliary sphincterotomy of duodenal major papilla;
- Patients able to provide a written informed consent
Who cannot join
- ERCP performed for disorders unrelated to biliary tract;
- Previous upper gastrointestinal tract surgery;
- Presence of a duodenal stricture (either malignant or benign);
- Presence of a malignant infiltration of the papilla;
- Concomitant anticoagulant and/or P2Y12 inhibitors therapy (clopidogrel, prasugrel, ticagrelor) that precludes the treatment;
- INR > 1.5;
- Platelets count < 80000/mm3;
- Unwillingness to sign written informed consent.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
IVO BOSKOSKI, +390630155701, ivo.boskoski@policlinicogemelli.it
IVO BOSKOSKI
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Roma, 00168
Ivo Boskoski, MD, PhD, 00390630156580, ivo.boskoski@policlinicogemelli.it
About this study
Official title: Prediction of Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis Based on the Appearance of the Major Duodenal Papilla: a Prospective, Observational, Cohort Study
This observational, prospective study aims at evaluating how the occurrence of post-Endoscopic Retrograde CholangioPancreatography (ERCP) acute pancreatitis (PEP) could be influenced by difficult biliary cannulation that might be previously assessed by the morphological appearance of native major papilla in all the patients undergoing ERCP.
The rate of successful biliary cannulation across papilla types could be used as intraprocedural quality and competence metrics during training. Moreover, recognizing difficult papillae could allow reserving those to experts to decrease the odds of failed cannulation.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Retrograde Cholangio-Pancreatography (ERCP)Procedure or surgery
ERCP performed for clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PEP occurrence
Rate of PEP occurrence distributed between the different native major duodenal papilla types
Measured: within 48 hours after the procedure
Secondary outcomes (6)
Rate of difficult biliary cannulation
Rate of difficult biliary cannulation (> 5 cannulation attempts and/or > 5 minutes attempting to cannulate biliary duct and/or at least one passage in the pancreatic duct) distributed between the different native major duodenal papilla types
Measured: during the procedure
Rate of difficult biliary cannulation
Rate of difficult biliary cannulation distributed between the different types of the intramural papillary segments on fluoroscopic images
Measured: during the procedure
Rate of intraoperative complications
Rate of intraoperative complications distributed between the different native major duodenal papilla types
Measured: during the procedure
Rate of postoperative complications except for PEP
Rate of postoperative complications except for PEP (up to 48 hours after ERCP) distributed between the different native major duodenal papilla types
Measured: within 48 hours after the procedure
Difference in the rate of difficult biliary cannulation
Difference in the rate of difficult biliary cannulation between ERCP experts (>300 performed procedures) and fellows (<300 performed procedures)
Measured: during the procedure
occurrence of intra- and post-procedural complications
To evaluate the occurrence of intra- and post-procedural complications but PEP, fluoroscopic morphology of the papillary segment of distal bile duct, perioperative and intraoperative risk factors
Measured: within 48 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,740 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800626
- Sponsor's protocol ID
- 5534
- Acronym
- PredERCP
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis Based on the Appearance of the Major Duodenal Papilla: a Prospective, Observational, Cohort Study
- ClinicalTrials.gov ID
- NCT05800626
- Acronym / sponsor ID
- PredERCP / 5534
- Conditions
- Post-ERCP Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,740 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Apr 2023 (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.
This observational, prospective study aims at evaluating how the occurrence of post-Endoscopic Retrograde CholangioPancreatography (ERCP) acute pancreatitis (PEP) could be influenced by difficult biliary cannulation that might be previously assessed by the morphological appearance of native major papilla in all the patients undergoing ERCP.
The rate of successful biliary cannulation across papilla types could be used as intraprocedural quality and competence metrics during training. Moreover, recognizing difficult papillae could allow reserving those to experts to decrease the odds of failed cannulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all consecutive patients with a native major duodenal papilla undergoing ERCP. Patients that previously underwent ERCP with sphincterotomy will not be included. Patients will be considered enrolled after signing the informed consent form. All patients will be hospitalized for at least 24 hours after ERCP for clinical observation.
Key inclusion criteria (3 listed)
- Patients with native duodenal papilla;
- Any indication to ERCP +/- biliary sphincterotomy of duodenal major papilla;
- Patients able to provide a written informed consent
Key exclusion criteria (8 listed)
- ERCP performed for disorders unrelated to biliary tract;
- Previous upper gastrointestinal tract surgery;
- Presence of a duodenal stricture (either malignant or benign);
- Presence of a malignant infiltration of the papilla;
- Concomitant anticoagulant and/or P2Y12 inhibitors therapy (clopidogrel, prasugrel, ticagrelor) that precludes the treatment;
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 Retrograde Cholangio-Pancreatography (ERCP)ERCP performed for clinical practice | Procedure or surgery | – |
Primary outcome
Rate of PEP occurrence
Time frame: within 48 hours after the procedure
Rate of PEP occurrence distributed between the different native major duodenal papilla types
6 secondary outcomes
Rate of difficult biliary cannulation
Time frame: during the procedure
Rate of difficult biliary cannulation
Time frame: during the procedure
Rate of intraoperative complications
Time frame: during the procedure
Rate of postoperative complications except for PEP
Time frame: within 48 hours after the procedure
Difference in the rate of difficult biliary cannulation
Time frame: during the procedure
occurrence of intra- and post-procedural complications
Time frame: within 48 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
2 sites 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 Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites 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 3 inclusion and 8 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivo Boskoski (+390630156580, ivo.boskoski@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PEP occurrence (time frame: within 48 hours after the procedure). 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 28 Feb 2024.