ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP

University of Science and Technology of China (USTC)

Status: Unknown

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Procedure: EST+LBD+ENBD; Procedure: EST+LBD

Study type: Interventional

Funder types: Other

Identifiers

NCT02830984

ENBD-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

EST+LBD+ENBD group

Experimental group

Description:

Nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones

Treatment:

Procedure: EST+LBD+ENBD

EST+LBD group

Active Comparator group

Description:

Without nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones

Treatment:

Procedure: EST+LBD