ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP
ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP
Endoscopic retrograde cholangiopancreatography (ERCP) has become one of the most important
 techniques in the treatment of bile duct stones. A number of studies have been conducted
 using large-balloon dilation (LBD) after adequate EST to extract large bile duct stones. In
 those studies, the authors suggested that EST plus LBD might lower the risk of post procedure
 pancreatitis (PEP) by directing balloon dilation toward the bile duct rather than the
 pancreatic duct. It has been reported that EPBD followed by insertion of nasobiliary drainage
 catheter can prevent PEP. However, it is still unclear that nasobiliary drainage after
 endoscopic sphincterotomy plus large-balloon dilation for preventing postoperative
 pancreatitis in treating of large bile duct stones.The investigators therefore designed a
 prospective randomized trial to determine whether nasobiliary drainage prevent PEP after
 endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.
Patients enrolled were confirmed the presence of CBD stones using magnetic resonance
 cholangiopancreatography. Patients with large bile duct stones were randomly assigned to
 EST+LBD+ENBD group and EST+LBD group. A descriptive analysis will be performed on primary
 endpoint, containing frequency of number and percentage of patients. A two proportion
 equality test will be conducted to explore whether incidence rates are different. Descriptive
 statistics including number (N), mean, median, standard deviation, minimum and maximum, will
 be produced for all continuous variables. Frequency tables of number (N) and percentage of
 subjects will be produced for all categorical variables.
Inclusion Criteria:

 -  Patients with visualized bile duct stones ≥12 mm in maximum transverse diameter. -
 Males and females, age > 18 years.

 -  Normal amylase level before undergoing ERCP.

 -  Signed inform consent form and agreed to follow-up on time.

 Exclusion Criteria:

 -  Bleeding diathesis

 -  Prior EST or EPBD or ENBD

 -  Billroth II or Roux-en-Y anatomy

 -  Distal extrahepatic bile duct stenosis

 -  Acute pancreatitis

 -  Intrahepatic bile duct stones.