We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953199
First Posted: August 6, 2009
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Abraham Mathew MD, Penn State Milton S. Hershey Medical Center
Results First Submitted: January 19, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Pancreatitis
Interventions: Drug: Lidocaine Hydrochloride
Drug: Normal Saline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
March 2010 -May 2013, recruited from the endoscopy unit

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lidocaine 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 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).

Participant Flow:   Overall Study
    Lidocaine   Normal Saline
STARTED   254   252 
COMPLETED   254   252 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Adult patients send for ERCP with a chance of contrast injection into the pancreatic duct

Reporting Groups
  Description
Lidocaine 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 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).
Total Total of all reporting groups

Baseline Measures
   Lidocaine   Normal Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 254   252   506 
Age 
[Units: Years]
Mean (Full Range)
 56 
 (18 to 99) 
 55.6 
 (19 to 92) 
 55.8 
 (18 to 99) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      128  50.4%      126  50.0%      254  50.2% 
Male      126  49.6%      126  50.0%      252  49.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Post ERCP Pancreatitis is the Primary Outcome.   [ Time Frame: 24-48 hours post-procedure ]

2.  Secondary:   Serum Amylase Levels   [ Time Frame: measurement is taken 2 hrs after ERCP ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Abraham Mathew MD
Organization: Penn State Hershey Medical center
phone: 717 531 3834
e-mail: amathew@hmc.psu.edu


Publications:

Responsible Party: Abraham Mathew MD, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00953199     History of Changes
Other Study ID Numbers: Lidocaine
First Submitted: August 4, 2009
First Posted: August 6, 2009
Results First Submitted: January 19, 2017
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017