Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

— QUASIE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698137
• Other study ID #: QUASIE2
• Status: Completed
• Start date: March 2016
• Est. completion date: July 2019

Study information

• Verified date: April 2020
• Source: Clinical Hospital Colentina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1843
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• refusal to sign the informed consent

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Croatia	GI Endoscopy Unit, Department of Gastroenterology and Hepatology, University Hospital Zagreb	Zagreb
Italy	Endoscopia Digestiva Chirurgica, Policlinico Gemelli	Roma
Romania	Gastroenterology Department, Colentina Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Colentina

Countries where clinical trial is conducted

Croatia,  Italy,  Romania, 

References & 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 (Buchar). 2014 Dec;9(4):328-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	technical failure of the procedure	percentage of procedures where the operator was unable to achieve the desired therapeutic goal (i.e selective cannulation, stone removal, stenting)	30 days