Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

NCT00953199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2017-10-03

Study results available
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Summary

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    collaborator OTHER
  • Abraham Mathew MD

    lead OTHER

Principal Investigators

  • Abraham Mathew, M.D., M.S. · Milton S. Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953199 on ClinicalTrials.gov