A Single Center, Randomized, Double-Blind Controlled Study of Topical Endoluminal Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis
| City: |
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Hershey |
| State: |
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Pennsylvania |
| Zip Code: |
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17033 |
| Conditions: |
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Pancreatitis |
| Purpose: |
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The purpose of this study is to determine if lidocaine is effective in reducing the
incidence of post-ERCP pancreatitis.
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| Study Summary: |
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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 caused by several factors, including intraductal pressure, multiple duct
injections with contrast, and neural arc reflexes. Lidocaine is a safe, inexpensive class
IV antiarrhythmic that has topical anesthetic effects, inhibits trypsin activity, and may
potentially prevent post-ERCP pancreatitis by injection directly into the pancreatic duct at
the time of ERCP. Lidocaine has been shown to inhibit phospholipase A2, a key pancreatic
enzyme, interrupt local arc reflexes to stop neuronal transmission, and to dampen GI tract
mucosal reflexes to prevent high ductal pressure.
The key objective of this study is to determine if injection of lidocaine is beneficial in
preventing post-ERCP pancreatitis. Subjects will be randomized to study group or control
group in an equal ratio. The physicians performing the ERCP will be unaware of the
treatment group to which patients have been assigned. Study arm will receive contrast agent
Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) during ERCP. Control arm will
receive contrast agent Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) during
ERCP. Diatrizoate diluted with normal saline is the standard of care. Patients will be
contacted 1 day and 1 week post-ERCP to assess for symptoms of pancreatitis.
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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
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| NCT ID: |
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NCT00953199 |
| Primary Contact: |
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Principal Investigator
Abraham Mathew, M.D., M.S.
Milton S. Hershey Medical Center
Abraham Mathew, M.D., M.S.
Phone: 717-531-3834
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| Backup Contact: |
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Email: bancrile@hmc.psu.edu
Brooke B Ancrile, Ph.D.
Phone: 717-531-0003 ext. 287992
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| Location Contact: |
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Hershey, Pennsylvania 17033
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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