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

NCT02830984 | Unknown DMC

• 1 other identifier: ENBD-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare EST+LBD+ENBD group EST+LBD with group on the incidence of hyperamylasemia/adverse events.

  the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups

Study Arms (2)

EST+LBD+ENBD group

EXPERIMENTAL

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

Procedure: EST+LBD+ENBD

EST+LBD group

ACTIVE COMPARATOR

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

Procedure: EST+LBD

Interventions

EST+LBD+ENBD PROCEDURE

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

EST+LBD+ENBD group

EST+LBD PROCEDURE

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

EST+LBD group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University

Hefei, Anhui, 230001, China

RECRUITING

Study Officials

• Shao Feng, MD

  Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shao Feng, MD

CONTACT

8613033090788; tagsmile1985@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2016
• First Posted: July 13, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 7, 2017

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)