Acute pancreatitis is a frequently devastating pancreatic inflammatory process that results
in extensive morbidity, mortality, and hospitalization costs. The incidence of acute
pancreatitis has been increasing over the last decade with an overall mortality rate of 5%,
although it may be as high as 30% in the most severe cases. It was the most common inpatient
gastrointestinal diagnosis in 2009, totaling over 270,000 hospitalizations with estimated
"inpatient costs" of over 2.5 billion dollars in the United States. However, despite the
significant impact to both patients and the healthcare system, there is no proven
pharmacologic therapy that improves important clinical outcomes in acute pancreatitis. The
release of bicarbonate rich fluid into the pancreatic duct from the ductal cells is an
important mechanism to protect against pancreatitis by two distinct mechanisms:
1. "Flushing" activated enzymes out of the pancreas and into the duodenum thereby
preventing accumulation of activated enzymes within the pancreatic acinus
2. Directly alkalinizing the acinar cells, which limits intra-acinar cell damage by
improving trafficking of inappropriately activated intra-acinar enzymes along the apical
membrane.
In addition to standard care, patients will be divided into 4 cohorts. Cohorts 1,2 and 3 will
be treated with different doses of intravenous synthetic human secretin. Cohort X will not
receive human secretin, but all datapoints and specimens will be collected. The patient
cohorts will be entered into the study as follows: Cohort X; Cohort 1; Cohort 2; Cohort 3. 5
patients in each cohort will be evaluated at each center (for a total of n=10 at both centers
for each cohort). Dosing will start within 24 hours of hospitalization with no further
synthetic human secretin administration beyond Day 3. Patients will continue to be followed
for 7 days or until discharge, whichever comes first. Any data recorded to that point would
be included in an intent-to-treat analysis. The primary objective is to perform a Phase II
Pilot Study to explore the efficacy of intravenous synthetic human secretin as a
pharmacologic adjunct to modulate the severity of human acute (non-obstructive) pancreatitis.