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

This study has been terminated.
(funding unavailable)
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01455311
First received: October 17, 2011
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Pancreatic Tumors
Procedure: EUS Guided Fine Needle Aspiration
Procedure: EUS Guided EchoBrush Sampling

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in the Diagnosis of Cystic Pancreatic Tumors

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Rank The Diagnostic Accuracy of Specimen [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Cataloging Proteins [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Cataloging proteins that are expressed in the cyst fluid collected from Pancreatic cystic tumors using Proteomic analysis.


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.


Enrollment: 21
Study Start Date: September 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: EUS-FNA
Procedure: EUS Guided EchoBrush Sampling
EUS-guided brushing of the cyst wall
Other Names:
  • EchoBrush®
  • Endoscopic Ultrasound Cytology Brush

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455311

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
American Cancer Society, Inc.
Investigators
Principal Investigator: Shivakumar Vignesh, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01455311     History of Changes
Other Study ID Numbers: MCC-15973
Study First Received: October 17, 2011
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
cystic pancreatic tumors
cystic pancreatic lesions
gastrointestinal
GI
EUS-FNA
EchoBrush®
cytology brush
endoscopic

Additional relevant MeSH terms:
Neoplasms
Pancreatic Cyst
Pancreatic Neoplasms
Cysts
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014