Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Post-ERCP Acute Pancreatitis

In brief

Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP. Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis. Despite this, no study to date has evaluated both of these measures for preventing post-ERCP pancreatitis. It is our hope to evaluate the combination of these two modalities for preventing post-ERCP pancreatitis compared with either modality alone.

Key facts

Study ID

NCT02641561

Run by

The Cooper Health System

People needed

192

Starts

2014-10-01

Expected to finish

2016-06-01

Last updated by the study team

2018-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 1 Subjects who are undergoing endoscopic retrograde cholangiopancreatography (ERCP)
• Age > 18 years
• Non-pregnant
• Non-prisoners
• Subjects who can sign informed consent
• Serum Creatinine < 1.2 milligrams/deciliter (mg/dL)
• Subjects without renal failure (acute or chronic)
• Subjects without congestive heart failure (ejection fraction < 40%)
• Subjects without cirrhosis of the liver
• Subjects without allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)
• Subjects not on non-steroidal anti-inflammatory drugs NSAIDS prior to enrollment

You may not qualify if…

• Subjects who are not undergoing ERCP
• Age < 18 years
• Pregnancy
• Prisoners
• Subjects lacking the capacity to consent for themselves
• Serum Creatinine > 1.2 milligrams/deciliter (mg/dL)
• Subjects with renal failure (acute and chronic)
• Subjects with congestive heart failure (ejection fraction < 40%)
• Subjects with cirrhosis of the liver
• Subjects with allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)
• Subjects with gastrointestinal hemorrhage
• Subjects on chronic non-steroidal anti-inflammatory drugs NSAIDS
• Subjects with acute pancreatitis the day of their procedure (CITE 1-3)(APPENDIX 1)

Where it is running

• Cooper Hospital — Camden, New Jersey, United States

Full record on ClinicalTrials.gov

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