Los Angeles Prospective GI Biliary and EUS Series

AIMS A) Characterize unusual disease and pathologic presentations which require endoscopic
treatment in a large safety net hospital B) To study the impact of EUS and ERCP on the
management of these patients. C) Analyze how EUS and ERCP results correlate with other
radiographic methods including conventional ultrasound and computed tomography (CT) D)
Compare role of EUS and ERCP in a safety net versus tertiary care center

II) BACKGROUND Endscopic Ultrasound (EUS) which consists of an endscope containing a high
frequency transducer, has become standard of care to evaluate gastrointestinal cancer as
well as diseases included chronic pancreatitis. EUS with fine needle aspiration (FNA) has
been demonstrated to be the least invasive and most effective means to acquire tissue in a
number of situations included pancreas cancer and maligant lymph nodes. Endoscopic
Retrograde Cholangiopancreatography (ERCP) is a therapeutic procedure used to manage
choledocholithiasis, bile duct obstruction and occasional pancreatic ductal problems. Its
diagostic uses are now more limited with the advent of EUS and cross sectional radiographic
studies including CT and magnetic resonance cholangiopancreatography (MRCP).

A number of leading ERCP/EUS groups including those at the University of Alabama
(Birmingham, Alabama), the Cleveland Clinic (Cleveland Ohio) and the Mayo Clinic (Rochester,
Minnesota) have developed ERCP/EUS databases which have led to important insight about the
role of these procedure and the diseases they are used to manage. However, these groups and
indeed almost the entire world literature regarding EUS and ERCP focuses on America, Western
European, and Japanese populations.

The goal of this database will be to study the impact of EUS and ERCP on an underserved
population at LAC. The prevalence of certain diseases including cholangitis, large bile duct
stones, and gastric cancer are markedly higher at our institution than in other western
facilities presenting a unique opportunity to report how they are treated as part of
standard management.

IIIA) DESIGN AND METHODOLOGY

1. ALL PROCEDURES ARE DONE STRICTLY AS STANDARD OF CARE.

2. Detailed collection sheets containing no PHI but with detailed information about
laboratories, symptoms, radiographic tests, time of presentation and procedure detals
are prospectively completed for patients undergoing EUS or ERCP by the Gastroenterology
service at the USC Hospitals. The resulting pathology and clinical course are collected
on these anonymized forms.

3. The information in the extraction sheets is entered into a database stripped of all
personal health identifiers.

IIIB) PLANNED DATA COLLECTION

1. The aim of this project will be to develop a prospective database of EUS/ERCP cases at
USC.

2. For both ERCP and EUS cases detailed information regarding the presentation of the
patients will be noted. Specifically, which radiographic and biochemical markers and
clinical symptoms are of interest.

4) For EUS the outcomes include the confirmation by biopsies and imaging of the underlying
pathology.

5) For ERCP the outcomes are procedural success and more specifically bile duct stone
confirmation and removal, treatment of cholangitis, treatment of leaks biliary, and
decompression of obstruction. Success of anesthesia strategy is an aim of the collection.

6) For potential quality of care assessment procedure complications and success of
anesthesia strategy are a priori areas of study

IV) STATISTICAL CONSIDERATIONS As this study involves creation of a database of standard of
care management of patients by EUS and ERCP primarily descriptive statistics will be used in
future studies. If individual groups are compared (ie those with positive versus atypical
fine needle aspiration) chi squared versus t statistic will be used for analysis depending
on distribution..

Inclusion Criteria:

- All patients undergoing EUS or ERCP at LAC, UH, and Norris Cancer Hospitals as
standard of clinical care will be enrolled.

Exclusion Criteria:

- None of the patients will be excluded.