Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis
NCT ID: NCT00953199
Last Updated: 2017-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
506 participants
INTERVENTIONAL
2010-03-31
2013-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Lidocaine
Study subjects receive a 1:1 combination of 5 ml Diatrizoate 60% and 5 ml Lidocaine Hydrochloride 2%
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.
Normal Saline
The control arm receives a 1:1 combination of 5 ml Diatrizoate and 5ml saline.
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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Abraham Mathew MD
OTHER
Responsible Party
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Abraham Mathew MD
Professor of Medicine
Principal Investigators
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Abraham Mathew, M.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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Cosen-Binker LI, Binker MG, Negri G, Tiscornia O. Acute pancreatitis possible initial triggering mechanism and prophylaxis. Pancreatology. 2003;3(6):445-56. doi: 10.1159/000074972. Epub 2003 Nov 19.
Kiyonari Y, Nishina K, Mikawa K, Maekawa N, Obara H. Lidocaine attenuates acute lung injury induced by a combination of phospholipase A2 and trypsin. Crit Care Med. 2000 Feb;28(2):484-9. doi: 10.1097/00003246-200002000-00033.
Makela A, Kuusi T, Schroder T. Inhibition of serum phospholipase-A2 in acute pancreatitis by pharmacological agents in vitro. Scand J Clin Lab Invest. 1997 Aug;57(5):401-7. doi: 10.3109/00365519709084587.
Portiansky EL, Gonzalez PH. Protective effect of lidocaine in the experimental foot-and-mouth disease pancreatitis. Experientia. 1995 Nov 15;51(11):1060-2. doi: 10.1007/BF01946916.
Schroder T, Kinnunen PK, Lempinen M. Xylocaine treatment in experimental pancreatitis in pigs. Scand J Gastroenterol. 1978;13(7):863-5. doi: 10.3109/00365527809182204.
Schwartz JJ, Lew RJ, Ahmad NA, Shah JN, Ginsberg GG, Kochman ML, Brensinger CM, Long WB. The effect of lidocaine sprayed on the major duodenal papilla on the frequency of post-ERCP pancreatitis. Gastrointest Endosc. 2004 Feb;59(2):179-84. doi: 10.1016/s0016-5107(03)02540-9.
Other Identifiers
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Lidocaine
Identifier Type: -
Identifier Source: org_study_id