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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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all consecutive patients undergoing ERCP in an endoscopy training program setting
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| Name | Affiliation | Role |
|---|---|---|
| Theodor Voiosu, MD, PhD | Clinical Hospital Colentina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GI Endoscopy Unit, Department of Gastroenterology and Hepatology, University Hospital Zagreb | Zagreb | 10000 | Croatia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25705300 | Background | 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. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Endoscopia Digestiva Chirurgica, Policlinico Gemelli |
| Roma |
| Italy |
| Gastroenterology Department, Colentina Hospital | Bucharest | 020125 | Romania |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |