Post-ERCP Acute Pancreatitis
Conditions
Keywords
Post-ERCP Acute Pancreatitis, Normal Saline, Lactated Ringer's
Brief summary
This is a randomized, double-blinded, controlled trial. This study is a head to head comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients, with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally and will be continued throughout the procedure. A IVF bolus will be given at the end of the procedure and then continued as a continuous infusion. Our null hypothesis is that there will be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to patients receiving NS solution infusion.
Interventions
DRUGLactated Ringer
This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.
This is a Normal Saline solution infusion before, during, and after the ERCP procedure.
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
i. Possession of one of the following criteria which places the patient at high risk for post-ERCP pancreatitis and/or if patient is to undergo a planned endoscopic intervention deemed at high risk: 1. Suspicion of Oddi dysfunction 2. Personal history of post-ERCP pancreatitis 3. More than 8 cannulation attempts 4. Precut sphincterotomy 5. Endoscopic papillary balloon dilation of an intact sphincter 6. Endoscopic pancreatic duct sphincterotomy 7. Ampullectomy 8. Total bilirubin \< 1.0 ii. Or possession of two or more of the following minor criteria: 1. Female sex 2. Age under 50 years 3. Personal history of recurrent acute pancreatitis 4. Pancreatic duct injection leading to acinarization or over 3 pancreatic duct injections 5. Pancreatic duct cytology acquisition
Exclusion criteria
1. Patients aged less than 18 2. Inability to provide informed consent 3. Pregnancy 4. Active acute pancreatitis 5. Any contraindication to aggressive IVF hydration: evidence of clinical volume overload (peripheral or pulmonary edema), respiratory compromise (oxygen saturation \< 90% on room air), chronic kidney disease (creatinine clearance \< 40 mL/min), systolic congestive heart failure (ejection fraction \< 45%), cirrhosis, and severe electrolyte disturbance with sodium \<130 mEq/L or \>150 mEq/L 6. If patient does not undergo a planned high-risk intervention 7. If patient does not possess complete criteria which places them at high risk for post-ERCP pancreatitis 8. Patients with cholangitis 9. Patients with chronic and/or active pancreatitis 10. Patients with a true NSAID allergy 11. Patients greater than or equal to 75 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-ercp pancreatitis | 24 hours | The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed. |
Contacts
Primary ContactPrimary Investigator
Backup ContactResearcher
Outcome results
None listed