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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Pancreatitis trials