Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

Not Applicable

Not yet recruiting

• Conditions: Post-ERCP Acute Pancreatitis
• Interventions: Drug: Lactated Ringer; Drug: Normal Saline 0.9% Infusion Solution Bag

• Registration Number: NCT03215862
• Lead Sponsor: University of South Florida

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-10
• Last Update Submitted: 2017-07-10
• Study First Posted: 2017-07-12
• Last Update Posted: 2017-07-12
• Study Start: 2017-08-01
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Lactated Ringer	-
Control	Normal Saline 0.9% Infusion Solution Bag	-

Primary Outcome Measures

Name	Time	Method
Post-ercp pancreatitis	24 hours	The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed.