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

• Sponsor: ASST Rhodense (Other)
• Overall Status: Completed
• CT.gov ID: NCT02971579
• Collaborator: (none)
• Enrollment: 1,800
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 200.7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Diseases; Pancreatic Diseases	Procedure: ERCP

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 Design

• Study Type: Observational
• Actual Enrollment: 1800 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Jun 1, 2017

Outcome Measures

Primary Outcome Measures

1. Complications rate [30 days]

   Occurrence of post -ERCP complications

Secondary Outcome Measures

1. Rate of repeated procedure [30 days]

   The rate of ERCPs that have to be repeated within 1 month

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Willingness to participate in the study

Exclusion Criteria:

• Informed consent not subscribed

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Maggiore della Carità	Novara		Italy	28100

Sponsors and Collaborators

• ASST Rhodense

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: gianpiero manes, MD, ASST Rhodense
• ClinicalTrials.gov Identifier: NCT02971579
• Other Study ID Numbers: request
• First Posted: Nov 23, 2016
• Last Update Posted: Jan 20, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by gianpiero manes, MD, ASST Rhodense: ERCP; biliary diseases; Pancreatic diseases; outcome; Quality; Training
• Additional relevant MeSH terms: Pancreatic Diseases; Biliary Tract Diseases

Study Results

No Results Posted as of Jan 20, 2021