N/A N=506 Randomized Double-blind Prevention

Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

Pancreatitis

Bottom Line

View on ClinicalTrials.gov: NCT00953199 ↗

Enrolled (actual)

506

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Post ERCP Pancreatitis is the Primary Outcome. — 26; 20 participants — p=.45

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lidocaine Hydrochloride (Drug); Normal Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abraham Mathew MD
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Post ERCP Pancreatitis is the Primary Outcome.	26; 20	.45
SECONDARY Serum Amylase Levels	130; 128	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00953199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.