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:

  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

Sponsor: ASST Rhodense

Current Primary Outcome: Complications rate [ Time Frame: 30 days ]

Occurrence of post -ERCP complications


Original Primary Outcome: Same as current

Current Secondary Outcome: Rate of repeated procedure [ Time Frame: 30 days ]

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


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