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Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

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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:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Abraham Mathew MD, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE August 4, 2009
First Posted Date  ICMJE August 6, 2009
Results First Submitted Date  ICMJE January 19, 2017
Results First Posted Date  ICMJE October 3, 2017
Last Update Posted Date October 3, 2017
Study Start Date  ICMJE March 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
Serum Amylase Levels [ Time Frame: measurement is taken 2 hrs after ERCP ]
serum amylase levels are measure by a blood draw
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis
Official Title  ICMJE A Single Center, Randomized, Double-Blind Controlled Study of Topical Endoluminal Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis
Brief Summary The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pancreatitis
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Experimental: Lidocaine
    Study subjects receive a 1:1 combination of 5 ml Diatrizoate 60% and 5 ml Lidocaine Hydrochloride 2%
    Intervention: Drug: Lidocaine Hydrochloride
  • Active Comparator: Normal Saline
    The control arm receives a 1:1 combination of 5 ml Diatrizoate and 5ml saline.
    Intervention: Drug: Normal Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2013)
506
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2009)
1140
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00953199
Other Study ID Numbers  ICMJE Lidocaine
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abraham Mathew MD, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Abraham Mathew MD
Collaborators  ICMJE Milton S. Hershey Medical Center
Investigators  ICMJE
Principal Investigator: Abraham Mathew, M.D., M.S. Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date September 2017

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