Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Condition: Post-ERCP Acute Pancreatitis
MeSH terms: Pancreatitis
Intervention: Indomethacin; Lactated Ringer's Solution; Normal Saline; Placebo
Intervention description: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis; Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis; standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.; Placebo would be a suppository 50 mg x 2
Intervention MeSH terms: Indomethacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pancreatitis; ERCP; Indomethacin; Lactated ringer's

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        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

        Exclusion Criteria:

          -  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)