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Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

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ClinicalTrials.gov Identifier: NCT00953199
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Abraham Mathew MD, Milton S. Hershey Medical Center

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
Enrollment 506
Recruitment Details March 2010 -May 2013, recruited from the endoscopy unit
Pre-assignment Details  
Arm/Group Title Lidocaine Normal Saline
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 254 252
Completed 254 252
Not Completed 0 0
Arm/Group Title Lidocaine Normal Saline Total
Hide Arm/Group Description 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). Total of all reporting groups
Overall Number of Baseline Participants 254 252 506
Hide Baseline Analysis Population Description
Adult patients send for ERCP with a chance of contrast injection into the pancreatic duct
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 254 participants 252 participants 506 participants
56
(18 to 99)
55.6
(19 to 92)
55.8
(18 to 99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 252 participants 506 participants
Female
128
  50.4%
126
  50.0%
254
  50.2%
Male
126
  49.6%
126
  50.0%
252
  49.8%
1.Primary Outcome
Title Post ERCP Pancreatitis is the Primary Outcome.
Hide Description 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.
Time Frame 24-48 hours post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Normal Saline
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 254 252
Measure Type: Number
Unit of Measure: participants
26 20
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidocaine, Normal Saline
Comments We calculated the sample size to be 570 in each arm, providing 80% power, allocation 1:1, two-sided, alpha 0.05, withdrawal rate of 3% and a reduction in pancreatitis from 8% to 4%. Randomization is performed with permuted blocks of 20. Analysis is based on intention to treat.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .45
Comments .05 was set as level of significance
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Serum Amylase Levels
Hide Description serum amylase levels are measure by a blood draw
Time Frame measurement is taken 2 hrs after ERCP
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Normal Saline
Hide Arm/Group Description:

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.

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).
Overall Number of Participants Analyzed 254 252
Mean (Full Range)
Unit of Measure: units/liter
130
(30 to 1826)
128
(30 to 4000)
Time Frame Adverse event data was collected over 48 hrs. Patients are observed in the recovery area until they are discharged after ERCP or admitted, usually about 2-3 hrs. They are called after 24 -48 hrs and later after a week for follow up.
Adverse Event Reporting Description Pancreatitis and its symptoms were the study outcomes and not considered here as a separate adverse event
 
Arm/Group Title Lidocaine Normal Saline
Hide Arm/Group Description 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).
All-Cause Mortality
Lidocaine Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/254 (0.00%)   0/252 (0.00%) 
Hide Serious Adverse Events
Lidocaine Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/254 (0.00%)   0/252 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lidocaine Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/254 (0.00%)   0/252 (0.00%) 
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Abraham Mathew MD
Organization: Penn State Hershey Medical center
Phone: 717 531 3834
EMail: amathew@hmc.psu.edu
Publications:
Layout table for additonal information
Responsible Party: Abraham Mathew MD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00953199    
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