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

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02830984
• Other study ID #: ENBD-001
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2016
• Last updated: March 5, 2017
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2016
• Source: Anhui Provincial Hospital
• Contact: Shao Feng, MD
• Phone: 8613033090788
• Email: tagsmile1985[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Procedure:
• EST+LBD+ENBD
Nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones
• EST+LBD
Without nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones

Locations

Country	Name	City	State
China	Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University	HeFei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prophylaxis effect of ENBD on post-ERCP pancreatitis after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.	If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis).; Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.	the incidence of post-ERCP pancreatitis at 24 h after ERCP in two groups
Secondary	Compare EST+LBD+ENBD group EST+LBD with group on the incidence of hyperamylasemia/adverse events.	Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms. During the study, any unexpected medical issue will be called adverse event.; Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.	the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups