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| Name | Class |
|---|---|
| Turku University Hospital | OTHER_GOV |
| Oulu University Hospital | OTHER |
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The purpose of the study is to compare two different techniques (pancreatic sphincterotomy (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and the success of cannulation in difficult cannulation. For the study, the difficult cannulation is de-fined as situation when the common bile duct has not been cannulated in five minutes, after five attempts or after two pancreatic guide wire passages or when any of those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The primary end-point is the risk of PEP .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic sphincterotomy | Active Comparator | Pancreatic sphincterotomy technique used in difficult biliary cannulation |
|
| Double guide wire | Active Comparator | Double guide wire technique used in difficult biliary cannulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biliary cannulation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post ERCP pancreatitis defined by ESGE guidelines published 2014 | Acute pancreatitis within 48 hours post ERCP. Post-ERCP pancreatitis (PEP) is defined as the presence of abdominal pain attributable to acute pancreatitis, together with a need for an unplanned hospitalization or an extension of a planned hospitalization by at least 2 days, and a serum /plasma amylase at least 3 times above the upper limit of normal at 24 hours after the procedure. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Biliary cannulation success within 15 minutes after randomization | After randomization, timing to get the wire in biliary duct. First assessed the number of procedures succeeded in 15 minutes. | 15 minutes |
| Biliary cannulation success, total number |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24628493 | Background | Halttunen J, Meisner S, Aabakken L, Arnelo U, Gronroos J, Hauge T, Kleveland PM, Nordblad Schmidt P, Saarela A, Swahn F, Toth E, Mustonen H, Lohr JM. Difficult cannulation as defined by a prospective study of the Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs. Scand J Gastroenterol. 2014 Jun;49(6):752-8. doi: 10.3109/00365521.2014.894120. Epub 2014 Mar 14. |
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The total number of successful biliary cannulations after randomization
| 2 hours |