NCT02698137

Brief Summary

The investigators will prospectively collect patient and procedure-related data in an observational study in order to detect patient and procedure-related risk factors for poor outcome (i.e. technical failure of the procedure; procedure-related complications). Data will be prospectively reported using standard report forms and patients will be followed up to 30 days to detect late-onset complications.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,843

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

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

First Submitted

Initial submission to the registry

February 24, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

2.8 years

First QC Date

February 24, 2016

Last Update Submit

April 8, 2020

Conditions

Cholangiopancreatography, Endoscopic RetrogradeCommon Bile Duct LithiasisBiliary StricturesBile Duct and Pancreatic Tumors

Outcome Measures

Primary Outcomes (1)

  • procedure-related adverse events

    the percentage of patients experiencing procedure-related adverse events (i.e post-ERCP pancreatitis; postERCP cholangitis; perforation; postERCP bleeding or death) occuring within 30 days of the procedure

    30 days

Secondary Outcomes (1)

  • technical failure of the procedure

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all consecutive patients undergoing ERCP in an endoscopy training program setting

You may qualify if:

  • all patients undergoing ERCP with attempted cannulation of either the major or minor papilla

You may not qualify if:

  • refusal to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GI Endoscopy Unit, Department of Gastroenterology and Hepatology, University Hospital Zagreb

Zagreb, 10000, Croatia

Location

Endoscopia Digestiva Chirurgica, Policlinico Gemelli

Roma, Italy

Location

Gastroenterology Department, Colentina Hospital

Bucharest, 020125, Romania

Location

Related Publications (1)

  • Voiosu TA, Bengus A, Haidar A, Rimbas M, Zlate A, Balanescu P, Voiosu A, Voiosu R, Mateescu B. Antibiotic Prophylaxis Prior to Elective ERCP Does Not Alter Cholangitis Rates or Shorten Hospital Stay: Results of an Observational Prospective Study of 138 Consecutive ERCPS. Maedica (Bucur). 2014 Dec;9(4):328-32.

    PMID: 25705300BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Theodor Voiosu, MD, PhD

    Clinical Hospital Colentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 3, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2019

Study Completion

July 1, 2019

Last Updated

April 9, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)IT(1)CR(1)