Clinical trial NCT05800626: Prediction of PEP Based on the Appearance of the Major Duodenal Papilla
Official title: Prediction of Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis Based on the Appearance of the Major Duodenal Papilla: a Prospective, Observational, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 1740
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Patients with native duodenal papilla;
* Any indication to ERCP +/- biliary sphincterotomy of duodenal major papilla;
* Patients able to provide a written informed consent

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of PEP occurrence
timeFrame: within 48 hours after the procedure
Secondary outcomes:
measure: Rate of difficult biliary cannulation
timeFrame: during the procedure
measure: Rate of difficult biliary cannulation
timeFrame: during the procedure
measure: Rate of intraoperative complications
timeFrame: during the procedure
measure: Rate of postoperative complications except for PEP
timeFrame: within 48 hours after the procedure
measure: Difference in the rate of difficult biliary cannulation
timeFrame: during the procedure
measure: occurrence of intra- and post-procedural complications
timeFrame: within 48 hours after the procedure
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Roma
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References: