A Register on the Quality of ERCP and Training of Endosco... | NCT02971579

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

NCT02971579

Sponsor

ASST Rhodense

Status

Completed

Last Update Posted

Jan 20, 2021Actual

Enrollment

1,800Actual

Phase

Not provided

Conditions

Biliary Tract Diseases
Pancreatic Diseases

Interventions

ERCP

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Nov 2016Actual

Completion Date

Jun 2017Actual

First Submitted Date

Nov 20, 2016

First Submission Date that Met QC Criteria

Nov 20, 2016

First Posted Date

Nov 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2021

Last Update Posted Date

Jan 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,800Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ERCP	Procedure	Endoscopic procedure used to manage biliary and pancreatic diseases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications rate	Occurrence of post -ERCP complications	30 days

Secondary Outcomes

Measure	Description	Time Frame
Rate of repeated procedure	The rate of ERCPs that have to be repeated within 1 month	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willingness to participate in the study

Exclusion Criteria:

Informed consent not subscribed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive adult patients undergoing ERCP for various indications

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pietro Occhipinti, MD	AOU Maggiore della Carità Novara	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Maggiore della Carità		Novara		28100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001660	Biliary Tract Diseases
D010182	Pancreatic Diseases
D005705	Gallbladder Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002760	Cholangiopancreatography, Endoscopic Retrograde

Ancestor Terms

ID	Term
D002758	Cholangiography
D011860	Radiography, Abdominal
D011859	Radiography
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided