NCT02830984

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

Nasobiliary Drainage After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing Postoperative Pancreatitis in Treating of Large Bile Duct Stones

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

Type	Name	Description
PROCEDURE	EST+LBD+ENBD	Nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones
PROCEDURE	EST+LBD	Without nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2016-07-13
• Last updated: 2017-03-07

Locations

1 site across 1 country: China