Clinical trial NCT02698137: Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Common Bile Duct Lithiasis
Biliary Strictures
Bile Duct and Pancreatic Tumors
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 1843
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients undergoing ERCP in an endoscopy training program setting

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* refusal to sign the informed consent

Primary outcomes:
measure: procedure-related adverse events
timeFrame: 30 days
Secondary outcomes:
measure: technical failure of the procedure
timeFrame: 30 days
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: GI Endoscopy Unit, Department of Gastroenterology and Hepatology, University Hospital Zagreb
city: Roma
country: Italy
facility: Endoscopia Digestiva Chirurgica, Policlinico Gemelli
city: Bucharest
country: Romania
facility: Gastroenterology Department, Colentina Hospital
Study officials:
affiliation: Clinical Hospital Colentina
name: Theodor Voiosu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.