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

January 17, 2021 updated by: gianpiero manes, ASST Rhodense

A Network on the Quality of ERCP, on the Organization of the Endoscopic Units and on the Training of the Endoscopists in Italy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1800

Contacts and Locations

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

Study Locations

  • Italy
      • Novara, Italy, 28100
        • AOU Maggiore della Carita

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

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive adult patients undergoing ERCP for various indications

Description

Inclusion Criteria:

  • Willingness to participate in the study

Exclusion Criteria:

  • Informed consent not subscribed

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications rate
Time Frame: 30 days
Occurrence of post -ERCP complications
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of repeated procedure
Time Frame: 30 days
The rate of ERCPs that have to be repeated within 1 month
30 days

Collaborators and Investigators

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

Sponsor

ASST Rhodense

Investigators

  • Principal Investigator: Pietro Occhipinti, MD, AOU Maggiore della Carità Novara

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

September 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

November 20, 2016

First Submitted That Met QC Criteria

November 20, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 17, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • request

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

product manufactured in and exported from the U.S.

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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