Clinical trial NCT02830984: ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP
Official title: Nasobiliary Drainage After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing Postoperative Pancreatitis in Treating of Large Bile Duct Stones
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2016-07-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The prophylaxis effect of ENBD on post-ERCP pancreatitis after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.
timeFrame: the incidence of post-ERCP pancreatitis at 24 h after ERCP in two groups
Secondary outcomes:
measure: Compare EST+LBD+ENBD group EST+LBD with group on the incidence of hyperamylasemia/adverse events.
timeFrame: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups
Other outcomes:
Locations:
city: HeFei
country: China
facility: Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
state: Anhui
Study officials:
affiliation: Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
name: Shao Feng, MD
role: PRINCIPAL_INVESTIGATOR
References: