High Volume Lactated Ringer's Solution and Pancreatitis

Therapuetic Areas:Gastroenterology
Age Range:18 - Any
Start Date:January 2014
Contact:Boris Jancan

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Perioperative Intravenous Administration of High Volume Lactated Ringer's Solution and the Risk of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

The purpose of this study is to examine whether giving large amounts of intravenous (IV)
fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis
(PEP). Pancreatitis is inflammation of the pancreas, and it is the most frequent serious
complication of ERCP. Typically, a small amount of IV fluids are given during this procedure
(~ 1 liter). We are testing whether using a larger amount of fluids (2 - 3 liters) will
reduce the risk of PEP.

This trial is designed as a phase II/III study. The phase II portion of the trial will be
completed to establish safety and efficacy data prior to proceeding with a phase III study.
The phase II trial will enroll 110 patients that are undergoing elective ERCP as
outpatients. Following the phase II portion, if the data suggests that the intervention arm
(high volume group) is safe, the investigators will begin enrolling patients who are
undergoing ERCP in a more urgent setting as inpatients.

We plan on enrolling 1,400 consecutive high risk patients undergoing ERCP. We are assuming a
baseline PEP risk of 9.2%. Fluid administration will be based on Ideal Body Weight (IBW) in
order to standardize the aggressive fluid administration across all body weights and reduce
the potential for adverse cardiopulmonary outcomes.

All participants will be monitored for 90 minutes following their procedure to assess the
development of any adverse symptoms. Analysis by a data safety monitoring board (DSMB) will
take place throughout the study. The DSMB is comprised of a panel of experts independent of
NorthShore University HealthSystem.

Inclusion Criteria:

Patients to be included in the study are those undergoing ERCP with the following:

- Clinical suspicion of sphincter of Oddi dysfunction

- History of post-ERCP pancreatitis (at least one episode)

- Pancreatic sphincterotomy

- Pre-cut (access) sphincterotomy

- Ampullectomy

Exclusion Criteria:

- Age < 18 years old

- Intrauterine pregnancy or breastfeeding mother

- Congestive heart failure

- Advanced/symptomatic coronary artery disease

- Known ascites

- Renal failure

- Active or recent gastrointestinal hemorrhage

- Acute pancreatitis within 72 hours prior to ERCP
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