Bile Duct Diseases Clinical Trial
Official title:
The Efficacy and Safety of Precut Papillotomy Using the Knob-tipped Knife and Needle Knife in Difficult Biliary Cannulation: a Randomized-controlled Trial.
The aim of the present study was to compare the efficacy and safety of the knob-tipped knife and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.
Precut sphincterotomy is an alternative technique used to facilitate CBD cannulation
following the failure of conventional bile duct cannulation. Needle knife papillotomy is the
most widely practiced precut technique. However,Pre-cutting the papilla with a needle-knife
is difficult, requiring experience and dexterity to control the axis and depth of the cut.
Due to the increased rate of complications associated with this procedure, including
pancreatitis, hemorrhage, and perforation, it was recommended to be performed only by
experienced endoscopists.
The knob-tipped knife, a novel instrument utilizing a 2mm or 1.5mm cutting knife, is usually
used for endoscopic submucosal dissection (ESD). Its knob-shaped tip and nonadjustable
length make the knife less likely to slip and penetrate the tissue during the resection.
Since the process of precut papillotomy is similar to ESD, the precutting procedure with the
knob-tipped knife may be easier to be performed, as well as be safer. The efficacy and
safety of this instrument in precut papillotomy have not been reported. We therefore
assessed the efficacy and safety of the knob-tipped knife in precut papillotomy in difficult
CBD cannulation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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