Clinical Trial: Compare the Knob-tipped Knife With the Needle Knife in Difficult Biliary Cannulation
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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.
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Changhai Hospital
Current Primary Outcome: Successful biliary cannulation rate after precut papillotomy [ Time Frame: During endoscopic retrograde cholangiopancreatography (ERCP) procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Biliary cannulation time after precut papillotomy [ Time Frame: From precut papillotomy started to biliary cannulation achieved or abandoned ]
Original Secondary Outcome: Same as current
Information By: Changhai Hospital
Dates:
Date Received: December 6, 2012
Date Started: December 2012
Date Completion: December 2014
Last Updated: December 7, 2012
Last Verified: December 2012
