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Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in the Diagnosis of Cystic Pancreatic Tumors

18 Years
85 Years
Not Enrolling
Pancreatic Tumors

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Trial Information

Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in the Diagnosis of Cystic Pancreatic Tumors

Patients who meet the inclusion and exclusion criteria will be offered the study and those
who consent will undergo Endoscopic Ultrasound (EUS) evaluation. All patients who consent to
the study will undergo Endoscopic Ultrasound guided fine needle aspiration (EUS-FNA) and EUS
guided EchoBrush. All patients will receive the recommended standard antibiotic prophylaxis
(Ciprofloxacin 400 mg IV given 30 minutes prior to EUS) that is used prior to EUS-FNA of
cystic pancreatic lesions and a prescription for oral Ciprofloxacin for 5 days post
procedure (standard of care).

Participants with pancreatic cysts that are >10 mm but under 25 mm: These patients will
undergo standard EUS-FNA of cyst fluid. From the first 19 participants, 0.5cc of aspirated
cyst fluid will be sent for Proteomic analysis and the rest for cytology. EUS guided
EchoBrush of the cyst wall will not be performed in this group of patients.

Participants with pancreatic cysts that are > 25 mm will undergo EUS guided Echobrush
sampling of the cyst wall at the same time they undergo EUS-FNA. This will be done using the
standard technique that is described below.

EUS guided cyst wall brushing and residual fluid aspirated after lavage with 2 cc of sterile
normal saline The tip of the Echobrush and the saline used to lavage the cyst will be placed
in the same specimen jar (Specimen 2) based on the discussion with published experts on the
EchoBrush technique. It should be noted that the pancreatic cyst will be punctured with the
19G FNA needle only once to obtain the specimens mentioned above. A single pass with EUS-FNA
is the standard of care for pancreatic cysts and this study does not alter standard of care.
It should be noted that the two groups represent two samples from the same patient and same
cystic lesion. Therefore each patient will serve as their own internal control. All patients
will be considered for surgical resection. Patients who do not undergo surgical resection
will be followed up per standard of care.

Inclusion Criteria:

- All patients must meet clinical criteria to undergo an Endoscopic Ultrasound (EUS)
with fine needle aspiration (FNA).

- Pancreatic cystic lesion with a minimum diameter of 10 mm noted on a previous
cross-sectional imaging modality

- All races will be eligible

Exclusion Criteria:

- Coagulopathy defined as an prothrombin time (PT) > 13.5 seconds or partial
thromboplastin time (PTT) > 35 seconds

- Thrombocytopenia defined as a platelet count < 50, 000

- Known pancreatic cancer

- Recent pancreatitis defined as an episode of pancreatitis within 4 weeks of study

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Rank The Diagnostic Accuracy of Specimen

Outcome Description:

The difference in diagnostic accuracy between the cytological grade of dysplasia on aspirated cyst fluid cytology (Specimen/ Group 1) and Echo Brush cytology (Specimen/ Group 2) when compared to surgical histology (Specimen 3). Specifically, the cellularity (scored 0 to 3) of specimen 1 will be compared to specimen 2 using the two-sample proportion test. In addition, the Spearman's rank correlation will be used to calculate the correlation between cytological grade of dysplasia of specimen 1 to specimen 3, and the correlation between specimen 2 to specimen 3.

Outcome Time Frame:

12 Months

Safety Issue:


Principal Investigator

Shivakumar Vignesh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

January 2013

Related Keywords:

  • Pancreatic Tumors
  • cystic pancreatic tumors
  • cystic pancreatic lesions
  • gastrointestinal
  • GI
  • EchoBrush®
  • cytology brush
  • endoscopic
  • Pancreatic Cyst
  • Pancreatic Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612