NCT02971579

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

November 20, 2016

Last Update Submit

January 17, 2021

Conditions

Biliary Tract DiseasesPancreatic Diseases

Keywords

ERCPbiliary diseasesPancreatic diseasesoutcomeQualityTraining

Outcome Measures

Primary Outcomes (1)

  • Complications rate

    Occurrence of post -ERCP complications

    30 days

Secondary Outcomes (1)

  • Rate of repeated procedure

    30 days

Interventions

ERCPPROCEDURE

Endoscopic procedure used to manage biliary and pancreatic diseases

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive adult patients undergoing ERCP for various indications

You may qualify if:

  • Willingness to participate in the study

You may not qualify if:

  • Informed consent not subscribed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Maggiore della Carità

Novara, 28100, Italy

Location

MeSH Terms

Conditions

Biliary Tract DiseasesPancreatic DiseasesGallbladder Diseases

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Pietro Occhipinti, MD

    AOU Maggiore della Carità Novara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 20, 2016

First Posted

November 23, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2016

Study Completion

June 1, 2017

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)