Actively Recruiting

Age: 18Years +
All Genders
ID06776874

Observational Study to Develop and Validate Predictive Scores for Adverse Events After Endoscopic Retrograde Cholangiopancreatography (ERCP)

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-15

981

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adverse events related to endoscopic retrograde cholangiopancreatography (ERCP), a key procedure for treating biliopancreatic diseases. The study aims to identify factors that increase the risk of complications after ERCP, develop and validate predictive models for these events, and evaluate the rate of complications in participating centers. This will help improve patient information and decision-making during treatment. Participants will undergo ERCP according to normal clinical practice without any changes to their treatment. The study involves applying two predictive models—one based on pre-procedural factors and another including both pre- and intra-procedural factors—to a group of patients undergoing ERCP. These models are evaluated for their ability to predict adverse events following the procedure. During the study, researchers will collect data on post-ERCP complications over 14 days following the procedure. There are no experimental interventions or added procedures, and patient care follows routine clinical protocols. The study will monitor and analyze complication rates to validate the predictive models and better understand risk factors for adverse events after ERCP.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >18 years
  • Patients admitted with hepato-biliary-pancreatic disease or other conditions requiring ERCP treatment
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Day of procedure

Participants undergo ERCP as part of their normal clinical care to assess and treat hepato-biliary-pancreatic conditions.

1 visit (in-person)

Long-term Monitoring

Duration - 14 days

Participants are observed for adverse events following ERCP to identify and validate predictive risk factors.

Follow-up assessments during 14 days after ERCP

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

L

Lorenzo Fuccio, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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