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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis||Drug: Lidocaine Hydrochloride Drug: Normal Saline||Not Applicable|
Post endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis is a common cause of morbidity for which there is no known pharmacologic prophylaxis. Post-ERCP pancreatitis is thought to be caused by several factors, including intraductal pressure, multiple duct injections with contrast, and neural arc reflexes. Lidocaine is a safe, inexpensive class IV antiarrhythmic that has topical anesthetic effects, inhibits trypsin activity, and may potentially prevent post-ERCP pancreatitis by injection directly into the pancreatic duct at the time of ERCP. Lidocaine has been shown to inhibit phospholipase A2, a key pancreatic enzyme, interrupt local arc reflexes to stop neuronal transmission, and to dampen GI tract mucosal reflexes to prevent high ductal pressure.
The key objective of this study is to determine if injection of lidocaine is beneficial in preventing post-ERCP pancreatitis. Subjects will be randomized to study group or control group in an equal ratio. The physicians performing the ERCP will be unaware of the treatment group to which patients have been assigned. Study arm will receive contrast agent Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) during ERCP. Control arm will receive contrast agent Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) during ERCP. Diatrizoate diluted with normal saline is the standard of care. Patients will be contacted 1 day and 1 week post-ERCP to assess for symptoms of pancreatitis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||506 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Single Center, Randomized, Double-Blind Controlled Study of Topical Endoluminal Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Study subjects receive a 1:1 combination of 5 ml Diatrizoate 60% and 5 ml Lidocaine Hydrochloride 2%
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.
Active Comparator: Normal Saline
The control arm receives a 1:1 combination of 5 ml Diatrizoate and 5ml saline.
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).
- Post ERCP Pancreatitis is the Primary Outcome. [ Time Frame: 24-48 hours post-procedure ]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.
- Serum Amylase Levels [ Time Frame: measurement is taken 2 hrs after ERCP ]serum amylase levels are measure by a blood draw
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953199
|United States, Pennsylvania|
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Abraham Mathew, M.D., M.S.||Milton S. Hershey Medical Center|