We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00953199
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Pancreatitis Drug: Lidocaine Hydrochloride Drug: Normal Saline

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 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Single Center, Randomized, Double-Blind Controlled Study of Topical Endoluminal Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis
Study Start Date : March 2010
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lidocaine
Study subjects receive a 1:1 combination of 5 ml Diatrizoate 60% and 5 ml Lidocaine Hydrochloride 2%
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.
Active Comparator: Normal Saline
The control arm receives a 1:1 combination of 5 ml Diatrizoate and 5ml saline.
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).


Outcome Measures

Primary Outcome Measures :
  1. Post ERCP Pancreatitis is the Primary Outcome. [ Time Frame: 24-48 hours post-procedure ]
    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.


Secondary Outcome Measures :
  1. Serum Amylase Levels [ Time Frame: measurement is taken 2 hrs after ERCP ]
    serum amylase levels are measure by a blood draw


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953199


Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Abraham Mathew MD
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Abraham Mathew, M.D., M.S. Milton S. Hershey Medical Center
More Information

Publications:
Responsible Party: Abraham Mathew MD, Professor of Medicine, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00953199     History of Changes
Other Study ID Numbers: Lidocaine
First Posted: August 6, 2009    Key Record Dates
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Abraham Mathew MD, Penn State Milton S. Hershey Medical Center:
endoscopic retrograde cholangiopancreatography
ERCP
pancreatitis
lidocaine
post-ERCP pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action