Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03215862
• Other study ID #: Pro00029546
• Status: Not yet recruiting
• Phase: N/A
• First received: July 10, 2017
• Last updated: July 10, 2017
• Start date: August 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: July 2017
• Source: University of South Florida
• Contact: Primary Investigator
• Phone: 8139743980
• Email: ptaunk[@]health.usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 242
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Drug:
• Lactated Ringer
This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.
• Normal Saline 0.9% Infusion Solution Bag
This is a Normal Saline solution infusion before, during, and after the ERCP procedure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ercp pancreatitis	The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed.	24 hours