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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02971579
Recruitment Status : Unknown
Verified November 2016 by gianpiero manes, ASST Rhodense.
Recruitment status was:  Recruiting
First Posted : November 23, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
gianpiero manes, ASST Rhodense

Tracking Information
First Submitted Date November 20, 2016
First Posted Date November 23, 2016
Last Update Posted Date November 29, 2016
Study Start Date September 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2016)
Complications rate [ Time Frame: 30 days ]
Occurrence of post -ERCP complications
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 20, 2016)
Rate of repeated procedure [ Time Frame: 30 days ]
The rate of ERCPs that have to be repeated within 1 month
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Register on the Quality of ERCP and Training of Endoscopists in Italy
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 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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Consecutive adult patients undergoing ERCP for various indications
Condition
  • Biliary Tract Diseases
  • Pancreatic Diseases
Intervention Procedure: ERCP
Endoscopic procedure used to manage biliary and pancreatic diseases
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 20, 2016)
1800
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Willingness to participate in the study

Exclusion Criteria:

  • Informed consent not subscribed
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02971579
Other Study ID Numbers request
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party gianpiero manes, ASST Rhodense
Study Sponsor ASST Rhodense
Collaborators Not Provided
Investigators
Principal Investigator: Pietro Occhipinti, MD AOU Maggiore della Carità Novara
PRS Account ASST Rhodense
Verification Date November 2016