NCT06776874

Brief Summary

The main objective of the study is: the identification of independent factors associated with an increased risk of post-ERCP complications. Other objectives are: the development of a predictive model of events post-ERCP adverse events and its validation; geographic validation of a predictive model already published in the literature using data collected during the study and the evaluation of the rate of post-ERCP AEs in the centers involved in the study.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
981

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2021

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 15, 2025

Status Verified

December 1, 2024

Enrollment Period

4.8 years

First QC Date

January 10, 2025

Last Update Submit

January 14, 2025

Conditions

Endoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

  • post-ERCP complications

    Identification of independent factors associated with an increased risk of post-ERCP complications.

    14 days

Study Arms (1)

Patients undergoing ERCP according to normal clinical practice

The validation of the present predictive model and the one already published in the Literature will involve the simple application of the two models to a cohort of patients (so-called validation group), undergoing ERCP according to normal clinical practice; therefore, there will be no interventions that would may alter the patient's normal course of treatment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing ERCP according to normal clinical practice

You may qualify if:

  • Age \>18 years
  • Patients admitted with hepato-biliary-pancreatic disease or other pathological conditions that require treatment by ERCP
  • Obtaining informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

  • Lorenzo Lorenzo, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Fuccio, MD

CONTACT

0512143338lorenzo.fuccio@aosp.bo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 15, 2025

Study Start

March 24, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 15, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)