Prospective Comparison of EUS-guided FNA and ERCP Tissue Sampling for the Diagnosis of Suspected Pancreato-biliary Neoplasms
Patients with pancreaticobiliary tumors usually present with painless jaundice due to bile
duct obstruction. The standard clinical evaluation may include EUS and/or ERCP. At centers
where EUS is available (like CPMC), it is usually used first as it is generally considered a
better tool for tumor detection, staging, and performing biopsies (FNA). ERCP is then
performed, if needed, to place a stent and relieve jaundice. As EUS is a relatively newer
technology that has not widely disseminated, other centers use ERCP as the 1st modality to
evaluate suspected malignant pancreaticobiliary obstruction. The role of ERCP in this
setting is to not only place a stent to relieve jaundice, but to additionally obtain
cytology brushings for tissue diagnosis.
Several studies have reported high sensitivity of EUS-FNA for detecting pancreaticobiliary
cancers that are causing bile duct obstruction and jaundice (80-90%). The sensitivity for
ERCP brushings and biopsies to detect the same types of tumors is reportedly lower (30-80%),
but there have been no direct comparisons of these techniques.
Few centers use both technologies (EUS and ERCP) for patient care, or often perform EUS and
ERCP at separate sessions. At CPMC, the investigators routinely perform EUS and ERCP
together for patients needing these procedures. Thus the investigators are in a unique
position to directly compare EUS-FNA to ERCP brushings for tissue diagnosis of suspected
The proposed study will be the 1st direct comparison of EUS-FNA to ERCP tissue sampling for
patients with suspected pancreaticobiliary cancers. Study results will highlight the best
approach to obtain a biopsy diagnosis of pancreatic and biliary tract cancers.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic
Direct comparison of tissue sampling techniques for patients with suspected pancreaticobiliary cancers.
Diagnostic yield from EUS-FNA samples will be compared to yield from ERCP tissue sampling methods (brushings and forceps biopsies).
Janak Shah, MD
California Pacific Medical Center
United States: Institutional Review Board
|California Pacific Medical Center||San Francisco, California 94115|