Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
186
Biliary access using needle knife fistulotomy technique
standard biliary cannulation
Thomas Jefferson University Hospial
Philadelphia, Pennsylvania, United States
post ERCP pancreatitis
Incidence of post ERCP pancreatitis defined as epigastric abdominal pain with lipase more than three times the upper limit of normal occurring within 48 hours of the procedure
Time frame: within 48 hours of the procedure
Bleeding
Significant bleeding was defined as a need for transfusion and/or need for repeat endoscopy for hemostasis
Time frame: within 48 hours
Perforation
Perforation, defined by a full thickness defect either seen during endoscopy or on radiological studies post procedure.
Time frame: within 48 hours
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