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

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ClinicalTrials.gov Identifier: NCT02830984
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Anhui Provincial Hospital

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.

Condition or disease Intervention/treatment Phase
Post-ERCP Acute Pancreatitis Procedure: EST+LBD+ENBD Procedure: EST+LBD Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Nasobiliary Drainage After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing Postoperative Pancreatitis in Treating of Large Bile Duct Stones
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: EST+LBD+ENBD group
Nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones
Procedure: EST+LBD+ENBD
Nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones
Active Comparator: EST+LBD group
Without 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



Primary Outcome Measures :
  1. The prophylaxis effect of ENBD on post-ERCP pancreatitis after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones. [ Time Frame: the incidence of post-ERCP pancreatitis at 24 h after ERCP in two groups ]

    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.



Secondary Outcome Measures :
  1. Compare EST+LBD+ENBD group EST+LBD with group on the incidence of hyperamylasemia/adverse events. [ Time Frame: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups ]

    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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830984


Contacts
Contact: Shao Feng, MD 8613033090788 tagsmile1985@163.com

Locations
China, Anhui
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University Recruiting
HeFei, Anhui, China, 230001
Contact: Shao Feng, MD    8613033090788    tagsmile1985@163.com   
Sponsors and Collaborators
Anhui Provincial Hospital
Investigators
Principal Investigator: Shao Feng, MD Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University

Responsible Party: Anhui Provincial Hospital
ClinicalTrials.gov Identifier: NCT02830984     History of Changes
Other Study ID Numbers: ENBD-001
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases