Cholangiopancreatography, Endoscopic Retrograde Clinical Trial
— QUASIE2Official title:
Quality Assessment in ERCP: Risk Factors for Procedure-related Complications in Patients Undergoing ERCP in the Setting of an Endoscopy Training Program
NCT number | NCT02698137 |
Other study ID # | QUASIE2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | July 2019 |
Verified date | April 2020 |
Source | Clinical Hospital Colentina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Clinical Hospital Colentina |
Croatia, Italy, Romania,
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
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 |
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