Pancreatitis
Conditions
Keywords
endoscopic retrograde cholangiopancreatography, ERCP, pancreatitis, lidocaine, post-ERCP pancreatitis
Brief summary
The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.
Detailed description
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.
Interventions
DRUGLidocaine 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.
DRUGNormal 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
Milton S. Hershey Medical Center
Abraham Mathew MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post ERCP Pancreatitis is the Primary Outcome. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Amylase Levels | measurement is taken 2 hrs after ERCP | serum amylase levels are measure by a blood draw |
Countries
United States
Participant flow
Recruitment details
March 2010 -May 2013, recruited from the endoscopy unit
Participants by arm
| Arm | Count |
|---|---|
| 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. | 254 |
| 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). | 252 |
| Total | 506 |
Baseline characteristics
| Characteristic | Lidocaine | Normal Saline | Total |
|---|---|---|---|
| Age, Continuous | 56 years | 55.6 years | 55.8 years |
| Sex: Female, Male Female | 128 Participants | 126 Participants | 254 Participants |
| Sex: Female, Male Male | 126 Participants | 126 Participants | 252 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 254 | 0 / 252 |
| other Total, other adverse events | 0 / 254 | 0 / 252 |
| serious Total, serious adverse events | 0 / 254 | 0 / 252 |
Outcome results
Primary
Post ERCP Pancreatitis is the Primary Outcome.
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Post ERCP Pancreatitis is the Primary Outcome. | 26 participants |
| Normal Saline | Post ERCP Pancreatitis is the Primary Outcome. | 20 participants |
Comparison: 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.p-value: 0.45Chi-squared
Secondary
Serum Amylase Levels
serum amylase levels are measure by a blood draw
Time frame: measurement is taken 2 hrs after ERCP
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lidocaine | Serum Amylase Levels | 130 units/liter |
| Normal Saline | Serum Amylase Levels | 128 units/liter |