Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

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.

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