QUASIE2: Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

Sponsor

Clinical Hospital Colentina (Other)

Overall Status

Completed

CT.gov ID

NCT02698137

Collaborator

(none)

1,843

Enrollment

Locations

Duration (Months)

614.3

Patients Per Site

15.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiopancreatography, Endoscopic Retrograde Common Bile Duct Lithiasis Biliary Strictures Bile Duct and Pancreatic Tumors

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1843 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Quality Assessment in ERCP: Risk Factors for Procedure-related Complications in Patients Undergoing ERCP in the Setting of an Endoscopy Training Program

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Outcome Measures

Primary Outcome Measures

procedure-related adverse events [30 days]
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

Secondary Outcome Measures

technical failure of the procedure [30 days]
percentage of procedures where the operator was unable to achieve the desired therapeutic goal (i.e selective cannulation, stone removal, stenting)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

refusal to sign the informed consent

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	GI Endoscopy Unit, Department of Gastroenterology and Hepatology, University Hospital Zagreb	Zagreb	Croatia	10000
2	Endoscopia Digestiva Chirurgica, Policlinico Gemelli	Roma	Italy
3	Gastroenterology Department, Colentina Hospital	Bucharest	Romania	020125

Sponsors and Collaborators

Clinical Hospital Colentina

Investigators

Principal Investigator: Theodor Voiosu, MD, PhD, Clinical Hospital Colentina

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

dr. Theodor Alexandru Voiosu, MD, PhD, Clinical Hospital Colentina

ClinicalTrials.gov Identifier:

NCT02698137

Other Study ID Numbers:

QUASIE2

First Posted:

Mar 3, 2016

Last Update Posted:

Apr 9, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Lithiasis

Study Results

No Results Posted as of Apr 9, 2020