Topical Pancreatic Duct Lidocaine for Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

This study has been completed.
Sponsor:
Collaborator:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Abraham Mathew MD, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00953199
First received: August 4, 2009
Last updated: August 14, 2013
Last verified: August 2013

August 4, 2009
August 14, 2013
March 2010
May 2013   (final data collection date for primary outcome measure)
The primary outcome of interest will be development of acute pancreatitis defined as new or worsening abdominal pain post-ERCP associated with an increase in serum amylase at least 3 times the upper limit of normal. [ Time Frame: 24-48 hours post-procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00953199 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Topical Pancreatic Duct Lidocaine for Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
A Single Center, Randomized, Double-Blind Controlled Study of Topical Endoluminal Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Pancreatitis
  • Drug: Lidocaine Hydrochloride
    1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
  • Drug: Normal Saline
    1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
  • Experimental: Lidocaine
    Intervention: Drug: Lidocaine Hydrochloride
  • Active Comparator: Normal Saline
    Intervention: Drug: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
506
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00953199
Lidocaine
Not Provided
Abraham Mathew MD, Penn State Milton S. Hershey Medical Center
Abraham Mathew MD
Milton S. Hershey Medical Center
Principal Investigator: Abraham Mathew, M.D., M.S. Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP