Observational Study to Develop a Predictive Score for Adverse Events Post ERCP

January 14, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Studio Osservazionale Per lo Sviluppo di Uno Score Predittivo Degli Eventi Avversi Post-colangiopancreatografia Retrograda Endoscopica (ERCP)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Endoscopic retrograde cholangiopancreatography (ERCP) was described for the first time in 1968 and today is the pivotal procedure for the treatment of various biliopancreatic diseases. ERCP is associated with adverse events (AEs) such as post-ERCP pancreatitis (PEP), cholangitis and also with mortality.AEs related to therapeutic ERCP have been variably reported in several studies, with an estimated range of 4-30% for all AEs and 0.1-1% for overall mortality. In a systematic review of 21 studies prospective studies found an overall AE rate of 6.85% with mortality of 0.33%. PEP (3-15%) and bleeding (1-5%) are the two most common AEs, followed by cholangitis (1-5%) and perforation (1-2%). Several studies have attempted to identify potential risk factors for EAs ERCP-relati. Many of these studies are limited by the heterogeneity of definitions, the use of outdated criteria for the definition of AEs and by not large samples of patients. A more precise identification of the risk factors of EA related to ERCP is important so that preventive therapies can be introduced early and more effectively monitor individuals at increased risk. A recent retrospective study by Eduardo-Rodrigues Pinto et al. conducted on 1491 consecutive patients undergoing 1991 ERCP procedures, identified, based on pre- and intra-procedural covariables, risk factors related to patient and procedure for EA, in order to develop, through a multivariate logistic regression analysis, a predictive score estimating the likelihood of the occurrence of EA post-ERCP. This would allow a more correct information to the patient about the procedure and an optimization of the decision making of the physician in charge of the patient. Two two models, one considering only pre-procedural factors (model 1) and the other that considers both pre- and intra-procedural factors (model 2); both showed moderate predictive ability (AUC-ROC of 0.668 and 0.684 respectively). The score is based on data from patients from a single institution and has not been validated prospectively or externally to the population on which it was developed. The main objective of the study is: the identification of independent factors associated with an increased risk of post-ERCP complications. The secondary 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 [12] using data collected during the study and the evaluation of the rate of post-ERCP AEs in the centers involved in the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
981

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing ERCP according to normal clinical practice

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
post-ERCP complications
Time Frame: 14 days
Identification of independent factors associated with an increased risk of post-ERCP complications.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lorenzo Lorenzo, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADVERCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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