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

Pancreatic Diseases Clinical Trial

— REQUEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971579
• Other study ID #: request
• Status: Completed
• Start date: September 2016
• Est. completion date: June 2017

Study information

• Verified date: January 2021
• Source: ASST Rhodense
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: June 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Willingness to participate in the study

Exclusion Criteria:

• Informed consent not subscribed

Related Conditions & MeSH terms

• Biliary Tract Diseases
• Pancreatic Diseases

Intervention

Procedure:
• ERCP
Endoscopic procedure used to manage biliary and pancreatic diseases

Locations

Country	Name	City	State
Italy	AOU Maggiore della Carità	Novara

Sponsors (1)

Lead Sponsor	Collaborator
ASST Rhodense

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications rate	Occurrence of post -ERCP complications	30 days
Secondary	Rate of repeated procedure	The rate of ERCPs that have to be repeated within 1 month	30 days