A Register on the Quality of ERCP and Training of Endoscopists in Italy

NCT ID: NCT02971579

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a prospective observational longitudinal study

Aim of the study is to collect information:

* on the organization models of the Endoscopic Units performing ERCP in Italy
* on the previous and/or ongoing training of the endoscopists performing ERCP
* on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Quality of ERCP in Italy has been object of various, mainly retrospective studies in Italy, but it has never systematically and prospectively evaluated in a large prospective series.

Moreover, the study aim at collecting data on the organization models of the Endoscopic Units performing ERCP in Italy; on the previous and/or ongoing training of the endoscopists performing ERCP; on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome of the procedure

The study consists of 3 phases:

1. Collection of the information on the Endoscopic Unit and on the endoscopists who performed ERCP in the center
2. Collection of data regarding consecutive ERCPs performed in adult patients in each center including demographic, clinical and procedural information
3. Definition of the the outcome of ERCP assessed after 30 days from the procedure

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Biliary Tract Diseases Pancreatic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ERCP

Endoscopic procedure used to manage biliary and pancreatic diseases

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willingness to participate in the study

Exclusion Criteria

* Informed consent not subscribed
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ASST Rhodense

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

gianpiero manes

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pietro Occhipinti, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Maggiore della Carità Novara

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AOU Maggiore della Carità

Novara, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

request

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Registry for Advanced Endoscopy
NCT05187312 RECRUITING