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The Clinical Impact of Immediate On-site Cytopathology Evaluation During Endoscopic Ultrasound-Guided Fine Needle Aspiration of Pancreatic Mass: A Multicenter, Prospective Randomized Controlled Trial

18 Years
Open (Enrolling by invite only)
Pancreatic Neoplasms, Pancreatic Cancer

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Trial Information

The Clinical Impact of Immediate On-site Cytopathology Evaluation During Endoscopic Ultrasound-Guided Fine Needle Aspiration of Pancreatic Mass: A Multicenter, Prospective Randomized Controlled Trial

Endoscopic Ultrasound (EUS) plays an integral role in the diagnosis of suspected pancreatic
cancer, and the EUS findings are crucial for determining the course of future management and
potential treatment options for these patients. EUS is the most sensitive imaging modality
for the detection of pancreatic masses, and has a sensitivity of greater than or equal to
90%. Furthermore, EUS-guided fine needle aspiration (EUS-FNA) plays an important role in
accurate staging of pancreatic cancer with a sensitivity of 85% and specificity close to
100%. EUS-FNA is considered to be cost-effective by virtue of its impact on therapeutic
management. In particular, real-time tissue sampling by EUS-FNA is possible when a
cytopathologist (pathologist skilled in evaluating fine needle aspiration specimens) is able
to be present at the time of FNA in order to review the biopsy slides and make a preliminary
diagnosis. The availability of an on-site cytopathologist has the potential to provide quick
diagnostic and predictive information to confirm the presence and staging of suspected
malignancy. The rationale for an on-site cytopathologist includes increasing the adequacy
and yield of biopsy tissue/aspirate which can decrease the need for additional passes to
obtain a diagnostic yield of tissue. This hypothesis, however, has not been formally

In this proposed randomized controlled multicenter trial, we hypothesize that an on-site
cytopathologist during EUS-FNA for pancreatic masses improves diagnostic yield, accuracy,
and lowers the duration, complications and the need for repeat procedures. This hypothesis
will be explored in the context of the following specific aims.

Specific aim #1: To compare the diagnostic yield of malignancy and proportion of inadequate
specimens between the two groups.

Specific aim #2: To compare the sensitivity, specificity and accuracy of EUS-FNA between the
two groups using histologic diagnosis or cytologic diagnosis in conjunction with clinical
and/or imaging follow-up as the gold standard.

Specific aim #3: To compare the duration, rate of complications and repeat procedures
between the two groups.

Inclusion Criteria:

- Patients age: greater than or equal to 18 years

- Presence of a solid pancreatic mass lesion confirmed by at least a single
investigational modality such as computerized axial tomography (CT) scan, magnetic
resonance imaging (MRI) or Endoscopic Ultrasound (EUS)

- Ability to provide written informed consent

Exclusion Criteria:

- Severe coagulopathy [International Normalized Ratio (INR) > 1.8] or thrombocytopenia
(platelet count <50,000)

- Pure cystic lesions of the pancreas

- Inability to sample lesion due to the presence of intervening blood vessels

- Results of EUS-FNA would not impact patient management

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Compare the percent of patients with a positive diagnosis of malignancy in each of the two groups

Outcome Description:

We would like to look at each of the two groups to assess whether or not having an onsite cytopathologist during EUS-FNA increases the diagnostic accuracy of pancreatic malignancies. To do this, we will compare the percent of patients in each group who were accurately diagnosed with a malignancy during EUS-FNA to see if the on-site cytopathologist group yields a higher percent of positively diagnosed malignancies.

Outcome Time Frame:

1 year from the time of patient enrollment

Safety Issue:


Principal Investigator

Sachin Wani, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

June 2011

Completion Date:

June 2013

Related Keywords:

  • Pancreatic Neoplasms
  • Pancreatic Cancer
  • Biopsy, Fine-Needle
  • Endoscopic Ultrasonography
  • cytopathology
  • Neoplasms
  • Pancreatic Neoplasms



Washington University School of Medicine Saint Louis, Missouri  63110