Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis
A Single Center, Randomized, Double-Blind Controlled Study of Topical Endoluminal Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis
1 other identifier
interventional
506
1 country
1
Brief Summary
The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
October 3, 2017
CompletedOctober 3, 2017
September 1, 2017
3.2 years
August 4, 2009
January 19, 2017
September 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post ERCP Pancreatitis is the Primary Outcome.
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.
24-48 hours post-procedure
Secondary Outcomes (1)
Serum Amylase Levels
measurement is taken 2 hrs after ERCP
Study Arms (2)
Lidocaine
EXPERIMENTALStudy subjects receive a 1:1 combination of 5 ml Diatrizoate 60% and 5 ml Lidocaine Hydrochloride 2%
Normal Saline
ACTIVE COMPARATORThe control arm receives a 1:1 combination of 5 ml Diatrizoate and 5ml saline.
Interventions
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abraham Mathew MDlead
- Milton S. Hershey Medical Centercollaborator
Study Sites (1)
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Related Publications (6)
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.
PMID: 14631103BACKGROUNDKiyonari 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.
PMID: 10708188BACKGROUNDMakela 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.
PMID: 9279965BACKGROUNDPortiansky 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.
PMID: 7498445BACKGROUNDSchroder T, Kinnunen PK, Lempinen M. Xylocaine treatment in experimental pancreatitis in pigs. Scand J Gastroenterol. 1978;13(7):863-5. doi: 10.3109/00365527809182204.
PMID: 725507BACKGROUNDSchwartz 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.
PMID: 14745389BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Abraham Mathew MD
- Organization
- Penn State Hershey Medical center
Study Officials
- PRINCIPAL INVESTIGATOR
Abraham Mathew, M.D., M.S.
Milton S. Hershey Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
March 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
October 3, 2017
Results First Posted
October 3, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share