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

NCT01455311 | Terminated

• 1 other identifier: MCC-15973
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Tumors

Keywords

cystic pancreatic tumors; cystic pancreatic lesions; gastrointestinal; GI; EUS-FNA; EchoBrush®; cytology brush; endoscopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cataloging Proteins

  12 Months

Study Arms (1)

Cystic Pancreatic Tumor Specimens

Specimen collection via EUS Guided Fine Needle Aspiration EchoBrush Sampling

Procedure: EUS Guided Fine Needle Aspiration; Procedure: EUS Guided EchoBrush Sampling

Interventions

EUS Guided Fine Needle Aspiration PROCEDURE

EUS-guided fine needle aspiration of the cyst fluid

Also known as: EUS-FNA

Cystic Pancreatic Tumor Specimens

EUS Guided EchoBrush Sampling PROCEDURE

EUS-guided brushing of the cyst wall

Also known as: EchoBrush®, Endoscopic Ultrasound Cytology Brush

Cystic Pancreatic Tumor Specimens

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cataloguing the proteins that are expressed in pancreatic cyst fluid will provide preliminary data that will be used for identification of candidate biomarkers to predict malignant transformation.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Shivakumar Vignesh, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 19, 2011
• Study Start: September 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (1)