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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing the Effects of EST and EPBD in Patients With Acute Biliary Pancreatitis

NCT02668081

Acute Biliary Pancreatitis

UNKNOWN NA

Endoscopic Papillary Large Balloon Dilatation Versus Mechanical Lithotripsy for Large Stones

NCT02666820

Common Bile Duct Stones

COMPLETED NA

The Effect of Different Duration of Bolloon Dilation During ESBD

NCT02958618

Common Bile Duct Stones

UNKNOWN NA

Long-duration EPBD vs EST for Removal of Biliary Stones

NCT03683485

Cholangiopancreatography, Endoscopic Retrograde

UNKNOWN NA

Comparison of Endoscopic Sphincterotomy Plus Large-balloon Dilatation and Conventional Treatment for Large CBD Stones

NCT02592811

Choledocholithiasis Large Common Bile Duct Stone

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Post-ERCP Acute Pancreatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EST+LBD+ENBD group

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

Group Type EXPERIMENTAL

EST+LBD+ENBD

Intervention Type PROCEDURE

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

EST+LBD group

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

Group Type ACTIVE_COMPARATOR

EST+LBD

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EST+LBD+ENBD

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

Intervention Type PROCEDURE

EST+LBD

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No