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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

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
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

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Study Type : Observational
Estimated 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 : September 2016
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Complications rate [ Time Frame: 30 days ]
    Occurrence of post -ERCP complications


Secondary Outcome Measures :
  1. Rate of repeated procedure [ Time Frame: 30 days ]
    The rate of ERCPs that have to be repeated within 1 month



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive adult patients undergoing ERCP for various indications
Criteria

Inclusion Criteria:

  • Willingness to participate in the study

Exclusion Criteria:

  • Informed consent not subscribed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971579


Contacts
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Contact: Pietro Occhipinti, MD -39 3356255730 pocchip@tin.it
Contact: gianpiero manes, MD <39 3477790886 gimanes@tin.it

Locations
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Italy
AOU Maggiore della Carità Recruiting
Novara, Italy, 28100
Contact: Pietro Occhipinti, MD    -39 3356255730    pocchip@tin.it   
Contact: gianpiero manes    -39 3477790886    gimanes@tin.it   
Sponsors and Collaborators
ASST Rhodense
Investigators
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Principal Investigator: Pietro Occhipinti, MD AOU Maggiore della Carità Novara

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Responsible Party: gianpiero manes, MD, ASST Rhodense
ClinicalTrials.gov Identifier: NCT02971579    
Other Study ID Numbers: request
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by gianpiero manes, ASST Rhodense:
ERCP
biliary diseases
Pancreatic diseases
outcome
Quality
Training
Additional relevant MeSH terms:
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Pancreatic Diseases
Biliary Tract Diseases
Digestive System Diseases