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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Tumors
• Intervention / Treatment: Procedure: EUS Guided Fine Needle Aspiration; Procedure: EUS Guided EchoBrush Sampling

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cystic Pancreatic Tumor Specimens; Specimen collection via EUS Guided Fine Needle Aspiration EchoBrush Sampling	Procedure: EUS Guided Fine Needle Aspiration; EUS-guided fine needle aspiration of the cyst fluid; Other Names: EUS-FNA; Procedure: EUS Guided EchoBrush Sampling; EUS-guided brushing of the cyst wall; Other Names: EchoBrush®; Endoscopic Ultrasound Cytology Brush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cataloging Proteins	Cataloging proteins that are expressed in the cyst fluid collected from Pancreatic cystic tumors using Proteomic analysis.	12 Months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Shivakumar Vignesh, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 17, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: EUS-FNA; endoscopic; GI; gastrointestinal; cystic pancreatic tumors; cystic pancreatic lesions; EchoBrush®; cytology brush
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Cysts; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Pancreatic Cyst
• Other Study ID Numbers: MCC-15973