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NCT Number: NCT02971579

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

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

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Key information

Conditions

Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Pancreatic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Maggiore della Carità

Novara, 28100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willingness to participate in the study

Exclusion criteria

  • Informed consent not subscribed

Treatment and study plan

ERCP

Procedure

Endoscopic procedure used to manage biliary and pancreatic diseases

Primary outcomes

  1. Complications rate

    Time frame: 30 days

    Occurrence of post -ERCP complications

Secondary outcomes

  1. Rate of repeated procedure

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

ASST Rhodense

Other

Registry information

Official study title

A Network on the Quality of ERCP, on the Organization of the Endoscopic Units and on the Training of the Endoscopists in Italy

Acronym: REQUEST

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Nov 23, 2016
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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