Status:
COMPLETED
Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis
Lead Sponsor:
Abraham Mathew MD
Collaborating Sponsors:
Milton S. Hershey Medical Center
Conditions:
Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.
Detailed Description
Post endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis is a common cause of morbidity for which there is no known pharmacologic prophylaxis. Post-ERCP pancreatitis is thought to be ca...
Eligibility Criteria
Inclusion
- Patients included are \>18 years old, referred to Endoscopy Clinic for an ERCP for any well established indication such as: biliary strictures, benign and malignant hepato-pancreato-biliary tumors, chronic pancreatitis, and suspected sphincter of Oddi dysfunction
Exclusion
- Known sensitivity to lidocaine or contrast agent
- History of seizure disorder
- History of cardiac arrhythmia (tachyarrhythmia, bradyarrhythmia, cardiac conduction defects, prolonged QT syndrome)
- History of congestive heart failure
- Active acute pancreatitis before procedure
- Planned biliary stent removal without pancreatogram
- Pregnancy
- Incarcerated individuals
- Less than 18 years of age
- Previous sphincterotomy
- Inability to give informed consent
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT00953199
Start Date
March 1 2010
End Date
May 1 2013
Last Update
October 3 2017
Active Locations (1)
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1
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033