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| Name | Class |
|---|---|
| Policlinico Gemelli, Rome, Italy | UNKNOWN |
| Cantacuzino Clinical Hospital, Bucharest, Romania | UNKNOWN |
| Zadar Hospital, Zadar, Croatia | UNKNOWN |
| University of Belgrade |
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The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.
The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.
It has previously shown that ERCP procedures with trainee involvement have no additional risk for the patient, but we aim to evaluate whether a subgroup of high-risk procedures can be identified to allow an improvement of the teaching of ERCP, including identifying some high risk features that might indicate that trainee involvement should not be warranted.
Briefly, the study is observational in nature and aims to gather clinical data about the patient and technical data about the procedure (including the degree of trainee involvement( to assess which (if any) procedures carry a higher risk for the patient in a training setting.
data will be gathered using a standard report form completed by the attending endoscopist at the end of each procedure; the form will then be updated at 30days interval with data about potential adverse events.
Patient identity will be protected throughout the study as per regulations in each institution and country; also all patients will sign an informed consent prior to the endoscopic procedure and study enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trainee Group | Patients who undergo ERCPs with trainee involvement |
| |
| control group | Patients who undergo ERCPs without any trainee involvement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP | Procedure | endoscopic retrograde cholangiopancreatography |
|
| Measure | Description | Time Frame |
|---|---|---|
| any procedure related adverse outcome | including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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all adult patients undergoing ERCP for any indication (diagnostic / therapeutic) in the participating centers
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| Name | Affiliation | Role |
|---|---|---|
| theodor voiosu, MD, PhD | Colentina Clinical Hospital, UMF Carol Davila Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colentina Clinical Hospital | Bucharest | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31766060 | Background | Voiosu T, Boskoski I, Voiosu AM, Bengus A, Ladic A, Klarin I, Bove V, Busuioc B, Rimbas M, Rustemovic N, Mateescu B, Jovanovic I, Costamagna G. Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial. Endoscopy. 2020 Feb;52(2):115-122. doi: 10.1055/a-1049-0359. Epub 2019 Nov 25. |
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| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| OTHER |
| UHC Zagreb, Zagreb, Croatia | OTHER_GOV |
| Oxford University Hospitals NHS Trust | OTHER |
| University of Colorado, Denver, USA | UNKNOWN |
| Medical University, Sofia, Bulgaria | UNKNOWN |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| ISUL Hospital, Sofia, Bulgaria | UNKNOWN |
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| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |