Post-ERCP Pancreatitis Severity Indication (PEPSI) Study

Endoscopic Retrograde Cholangiopancreaticography (ERCP) is an important diagnostic and
therapeutic tool in the management of pancreatic and biliary diseases. However, it carries up
to 10% risk of developing acute pancreatitis, 10% of which will be severe. Current models to
predict the severity of acute pancreatitis are incomplete and unable to prognosticate early
in the course of the disease because they are based on biomarkers of late immune response.
Recent findings suggest that polymorphisms in the gene coding for MCP-1 (Monocyte Chemotactic
Protein-1) play an important role in the early immune response leading to either mild versus
severe acute pancreatitis of various etiologies.

This study plans to directly address the problem of post-ERCP pancreatitis to gauge the
various factors involved in its development and genetic variability in the immune response to
an isolated pancreatic insult. In addition, we hope to study markers of the early immune
response to this injury and to develop a risk-assessment model.

Inclusion Criteria:

1. All people presenting for ERCP procedures.

2. Males and females of 14 years of age and older.

3. Willingness to participate in the study and sign the informed consent. (Children will
require a representative to sign the informed consent).

4. People in whom therapeutic pancreatic interventions are planned during the ERCP
procedure.

5. Intact papilla

Exclusion Criteria:

1. Persons unwilling to sign the informed consent

2. Disorientation secondary to irreversible organic brain damage.

3. Hemoglobin of less than 11 gm/dl in children of 10 years of age to puberty and
hemoglobin of 12 gm/dl in pubertal males and females.

4. Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.

5. ERCP scheduled for stent change

6. Previous diagnosis of pancreatic cancer or cholangiocarcinoma

7. History of chronic pancreatitis

8. Active Acute Pancreatitis prior to ERCP (typical pain and amylase or lipase >3 times
UNL)or smoldering pancreatitis

9. History of Recurrent Acute Pancreatitis with chronic pain between acute attacks of
>5/10 more than 3 days per week.

10. Previous sphincterotomy

11. Post surgical anatomy

12. History of organ transplant

13. On medications for the treatment of HIV