Clinical trial NCT01455311: Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in Diagnosis of Cystic Pancreatic Tumors
Official title: Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in the Diagnosis of Cystic Pancreatic Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Tumors
Keywords: cystic pancreatic tumors
cystic pancreatic lesions
gastrointestinal
GI
EUS-FNA
EchoBrush®
cytology brush
endoscopic
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2011-10-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study design will be prospective, and will include 48 consecutive adult patients between the ages of 18 and 85 years, with pancreatic cystic tumors identified on crosssectional imaging and referred for EUS evaluation per the following inclusion and exclusion criteria.

Brief summary: The goal of this study is to compare a sample of the cyst taken by a standard method (fine needle aspiration) to the sample taken by a new method using a device called the EchoBrush to see which method is more accurate at diagnosing cancer. We will also look at proteins (also called biomarkers) in the samples to see if they predict whether or not the cyst is cancerous.

Detailed description: 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.

Eligibility criteria: 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 enrollment

Primary outcomes:
measure: Rank The Diagnostic Accuracy of Specimen
timeFrame: 12 Months
Secondary outcomes:
measure: Cataloging Proteins
timeFrame: 12 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Shivakumar Vignesh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: