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Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| loop-tip arm | Experimental | The cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.) |
|
| Control arm | Active Comparator | The cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loop-tip wire (Cook Medical) for the cannulation of the CBD | Device |
| ||
| Cannulotome CT-25mm Cook Medical |
| Measure | Description | Time Frame |
|---|---|---|
| post ERCP pancreatitis rate | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Paolo Hospital | Recruiting | Milan | Italy | 20142 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26528503 | Derived | Masci E, Mangiavillano B, Luigiano C, Bizzotto A, Limido E, Cantu P, Manes G, Viaggi P, Spinzi G, Radaelli F, Mariani A, Virgilio C, Alibrandi A, Testoni PA. Comparison between loop-tip guidewire-assisted and conventional endoscopic cannulation in high risk patients. Endosc Int Open. 2015 Oct;3(5):E464-70. doi: 10.1055/s-0034-1392879. Epub 2015 Sep 15. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 4, 2016 | |
| Reset | Apr 1, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 4, 2016 | Apr 1, 2016 |
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| Device |
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