Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

Abraham Mathew MD

Status: Completed

Conditions: Pancreatitis

Treatments: Drug: Lidocaine Hydrochloride; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00953199

Lidocaine

Details and patient eligibility

About

The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.

Full 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 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.

Enrollment: 506 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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506 participants in 2 patient groups

Lidocaine

Experimental group

Description:

Study subjects receive a 1:1 combination of 5 ml Diatrizoate 60% and 5 ml Lidocaine Hydrochloride 2%

Treatment:

Drug: Lidocaine Hydrochloride

Normal Saline

Active Comparator group

Description:

The control arm receives a 1:1 combination of 5 ml Diatrizoate and 5ml saline.

Treatment:

Drug: Normal Saline