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Prospective Comparison of EUS-guided FNA and ERCP Tissue Sampling for the Diagnosis of Suspected Pancreato-biliary Neoplasms

18 Years
Open (Enrolling)
Pancreaticobiliary Cancers, Jaundice, Bile Duct Obstruction

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Trial Information

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
pancreaticobiliary tumors.

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.

Inclusion Criteria:

- Patients age >18 years that are scheduled for EUS and possible ERCP for the
evaluation of jaundice from suspected pancreaticobiliary tumors.

Exclusion Criteria:

- Patients that do not provide consent for EUS and ERCP (for standard clinical reasons)

- Patients that do not require ERCP based on EUS findings (e.g. no mass seen, mass is
not causing jaundice

- Patients in whom an additional 5 minutes of procedure time may increase the
procedural/sedation risks:

- pregnant patients

- patients with severe medical co-morbidities (ASA class 4 or 5)

- Patients with significant bleeding risk precluding endoscopic tissue sampling

- INR > 1.4 or Prothrombin time > 5 sec more than control

- Platelet count < 50,000

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic

Outcome Measure:

Direct comparison of tissue sampling techniques for patients with suspected pancreaticobiliary cancers.

Outcome Description:

Diagnostic yield from EUS-FNA samples will be compared to yield from ERCP tissue sampling methods (brushings and forceps biopsies).

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Janak Shah, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

California Pacific Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2011

Completion Date:

April 2013

Related Keywords:

  • Pancreaticobiliary Cancers
  • Jaundice
  • Bile Duct Obstruction
  • Cholestasis
  • Jaundice



California Pacific Medical Center San Francisco, California  94115