TerminatedPhase 2/3

High Volume Lactated Ringer's Solution and Pancreatitis

Stopped: Study was closed prematurely due to low enrollment numbers.

United States26 participantsStarted 2014-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Development of Post-ERCP Pancreatitis

Timeframe: Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure

Trial details

NCT IDNCT02050048

SponsorEndeavor Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

Results submitted2016-03-29

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