Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

University of South Florida

Status: Not yet enrolling

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Drug: Normal Saline 0.9% Infusion Solution Bag; Drug: Lactated Ringer

Study type: Interventional

Funder types: Other

Identifiers

NCT03215862

Pro00029546

Details and patient eligibility

About

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.

Enrollment: 242 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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242 participants in 2 patient groups

Control

Active Comparator group

Treatment:

Drug: Normal Saline 0.9% Infusion Solution Bag

Experimental

Experimental group

Treatment:

Drug: Lactated Ringer