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.
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Rank The Diagnostic Accuracy of Specimen
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.
Shivakumar Vignesh, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
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