Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

NCT ID: NCT02698137

Last Updated: 2020-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1843 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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This is an investigator-driven, prospective multicenter trial which analyzes the impact of trainee participation on procedure-related outcome (technical success and procedure-related complications).

All ERCPs in the participating centers will be documented using a standard report form which will require the attending endoscopist to provide data relating to the patient (age, gender, diagnosis, bilirubin levels) and the procedure (including but not limited to the indication, technical aspects including cannulation technique, time to cannulation, degree of trainee involvement - where appropriate, procedure-related adverse events and their outcome).

Because teaching ERCP is not yet a standardized procedure, we aim to assemble a large database, stemming from the experience of several teaching centers in order to identify the main patient and operator-related factors which might influence the outcome of the procedure.

Conditions

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Cholangiopancreatography, Endoscopic Retrograde Common Bile Duct Lithiasis Biliary Strictures Bile Duct and Pancreatic Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* refusal to sign the informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Hospital Colentina

OTHER

Sponsor Role lead

Responsible Party

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dr. Theodor Alexandru Voiosu

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theodor Voiosu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Colentina

Locations

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

Zagreb, , Croatia

Site Status

Endoscopia Digestiva Chirurgica, Policlinico Gemelli

Roma, , Italy

Site Status

Gastroenterology Department, Colentina Hospital

Bucharest, , Romania

Site Status

Countries

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Croatia Italy Romania

References

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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.

Reference Type BACKGROUND
PMID: 25705300 (View on PubMed)

Other Identifiers

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QUASIE2

Identifier Type: -

Identifier Source: org_study_id

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