Prediction of PEP Based on the Appearance of the Major Du... | NCT05800626

Studies
Prediction of PEP Based on the Appearance of the Major Duodenal Papilla

NCT05800626

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

Feb 28, 2024Actual

Enrollment

1,740Estimated

Phase

Not provided

Conditions

Post-ERCP Acute Pancreatitis

Interventions

Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 24, 2023

First Submission Date that Met QC Criteria

Mar 24, 2023

First Posted Date

Apr 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2024

Last Update Posted Date

Feb 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,740Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic Retrograde Cholangio-Pancreatography (ERCP)	Procedure	ERCP performed for clinical practice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of PEP occurrence	Rate of PEP occurrence distributed between the different native major duodenal papilla types	within 48 hours after the procedure

Secondary Outcomes

Measure	Description	Time Frame
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	during the procedure
Rate of difficult biliary cannulation

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ivo Boskoski	Contact	+390630156580		ivo.boskoski@policlinicogemelli.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Recruiting	Rome	Roma	00168	Italy