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Selective cannulation is considered the most challenging step for most of Endoscopic retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used. With one guidewire occupying pancreatic duct (PD), the following cannulation of common bile duct (CBD) with a sphincterotome preloaded with another guidewire often becomes feasible. However, because of the small opening of the papilla, sometimes it is technically challenging for the following cannulation of CBD with the sphincterotome and PD guidewire in the same working channel. We hypothesized that a tiny cut of the opening of papilla, without the injury of pancreatic sphincter, may facilitate the success of DWT and shorten the overall cannulation time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified double wire technique | Experimental | A sphincterotome was used for standard wire-guided cannulation. If the difficult biliary cannulation occurred and guidewire inadvertently entered PD, a tiny cut of opening, with the length of 5mm, was performed with the sphincterotome. Then the guidewire was left in PD and the sphincterotome withdrew. The same sphincterotome was re-inserted in the working channel alongside the first guidewire, another wire is used for wire-guided selective cannulation of CBD. If the cannulation of CBD was not successful within 5 attempts, other cannulation techniques (e.g. transpancreatic precut, needle knife (NK) precut or over-the stent precut) would be tried at the discretion of endoscopists. A 5Fr, unflanged PD stent was placed before the ending of ERCP. |
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| Standard double wire technique | No Intervention | A sphincterotome was used for standard wire-guided cannulation. If the difficult biliary cannulation occurred and guidewire inadvertently entered PD, the guidewire was left in PD and the sphincterotome withdrew. The same sphincterotome was re-inserted in the working channel alongside the first guidewire, another wire is used for wire-guided selective cannulation of CBD. If the cannulation of CBD was not successful within 5 attempts, other cannulation techniques (e.g. transpancreatic precut, NK precut or over-the stent precut) would be tried at the discretion of endoscopists. A 5Fr, unflanged PD stent was placed before the ending of ERCP. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified double wire technique | Procedure | For experimental arm, a tiny cut of papilla orifice, with the length of 5mm, was performed by sphincterotome before the double wire cannulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of double wire technique | the rate of successful cannulation of CBD for ≤5 attempts by using the sphincterotome alongside the PD guidewire. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| cannulation time of double wire technique | the time taken from the touching of papilla by the sphincterotome alongside the PD guidewire to the successful cannulation of CBD | 3 hours |
| Number of attempts for the successful CBD cannulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pan Yanglin, M.D. | Contact | +8613201851680 | panyanglin@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopic center, Xijing Hospital of Digestive Diseases | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| 3 hours |
| Overall cannulation success rate | 3 hours |
| complication rates | 48 hours |