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Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle (MUCIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sri Komanduri, Northwestern University
ClinicalTrials.gov Identifier:
NCT01769248
First received: January 10, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.

The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.


Condition Intervention
Pancreatic Mass
Abnormal Lymph Nodes
Mediastinal Masses
Gastric Submucosal Masses
Device: Fine needle aspiration
Device: Fine needle biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Diagnostic Yield of EUS-FNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The investigators' primary outcome measure will assess the diagnostic yield (%) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.


Secondary Outcome Measures:
  • Specimen adequacy as assessed by Rapid-onsite evaluation of FNA and FNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB


Enrollment: 140
Study Start Date: September 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FNA
fine needle aspiration
Device: Fine needle aspiration
Fine needle aspiration
Other Name: Echo Tip FNA Needle
Active Comparator: FNB
Fine needle biopsy
Device: Fine needle biopsy
FNB
Other Name: Echo Tip Procore

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent

Exclusion Criteria:

  • 3.2.1 Coagulopathy which is not corrected

3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB

  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: NCT01769248

Locations
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
California Pacific Medical Center
San Francisco, California, United States, 94117
United States, Florida
Moffit Cancer Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Srinadh Komanduri Northwestern University
  More Information

No publications provided

Responsible Party: Sri Komanduri, Associate Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01769248     History of Changes
Other Study ID Numbers: FNAFNBmucin
Study First Received: January 10, 2013
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
EUS
FNA
FNB

ClinicalTrials.gov processed this record on November 20, 2014