The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access with contrast injection even if results are conflicting. The aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in PEP high-risk patients. Type of study: Multicentric, prospective and randomized trial Patients: PEP high-risk patients underwent ERCP for benign biliary pathology Number of patients: 320 patients (160 for each group) Aim: Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
320
Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation
Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation
The evaluation of the incidence of PEP
Time frame: loop20216
The evaluation of CBD percentage cannulation.
Time frame: loop20216
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