This research is being done to see if using oral tacrolimus before endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).
Any patient who is undergoing endoscopic retrograde cholangiopancreatography (ERCP) at any of the participating centers, is at least 18 years old and provides informed consent can be included in the study.
Unwillingness or inability to consent for the study.
Pregnancy
Breastfeeding mother
Chronic calcific pancreatitis
Parallel
Tacrolimus capsule
DrugTacrolimus 5 mg PO, 1-2 hours prior to endoscopy
Placebo
DrugPlacebo PO, 1-2 hours prior to endoscopy.
Rectal Indomethacin
Drug100 mg Rectal Indomethacin immediately after ERCP, in high-risk patients.
The proportion of subjects in each study group with Post ERCP Acute Pancreatitis (PEP)
Incidence of PEP as defined by the consensus guidelines as 1. New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis 2. Amylase or lipase ≥ 3x the upper limit of normal 24 hours after the procedure 3. Hospitalization or prolongation of existing hospitalization for at least 2 days
The proportion of subjects in each study group with moderate-severe Post-ERCP Pancreatitis
PEP severity grading will be based on the modified Atlanta Criteria. * Mild PEP: Hospitalization ≤3 days without organ failure, local or systemic complications. * Moderate PEP: Hospitalization 4-10 days with transient organ failure that resolves within 48 hours and/or local or systemic complications. * Severe PEP: Hospitalization \>10 days with development of pancreatic necrosis or pseudocyst, persistent (\>48 hours) single or multiple organ failure, and/or need for additional endoscopic, percutaneous, or surgical intervention for pancreatitis-related complications.
Click on the lead sponsor to view all of their trials.
