Clinical Trial: A Register on the Quality of ERCP and Training of Endoscopists in Italy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
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
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
Detailed Summary:
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:
- Collection of the information on the Endoscopic Unit and on the endoscopists who performed ERCP in the center
- Collection of data regarding consecutive ERCPs performed in adult patients in each center including demographic, clinical and procedural information
- Definition of the the outcome of ERCP assessed after 30 days from the procedure
Sponsor: ASST Rhodense
Current Primary Outcome: Complications rate [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Rate of repeated procedure [ Time Frame: 30 days ]
Original Secondary Outcome: Same as current
Information By: ASST Rhodense
Dates:
Date Received: November 20, 2016
Date Started: September 2016
Date Completion: June 2017
Last Updated: November 28, 2016
Last Verified: November 2016