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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:
ClinicalTrials.gov Identifier:
NCT01769248
First Posted: January 16, 2013
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sri Komanduri, Northwestern University
  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 Cancer Lymphadenopathy Gastrointestinal Stromal Tumor Device: Fine needle aspiration Device: Fine needle biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

Resource links provided by NLM:


Further study details as provided by Sri Komanduri, Northwestern University:

Primary Outcome Measures:
  • Diagnostic Yield of EUS-FNB [ Time Frame: 1 year ]
    The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) 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 ]
    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

  • Percentage of Patients in Whom a Diagnosis is Acheived After Crossover (%) [ Time Frame: 1 yr ]
    As above. Crossover to FNA or FNB occurs after 3 passes without adequate material


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: Fine needle aspiration
fine needle aspiration
Device: Fine needle aspiration
Fine needle aspiration
Other Name: Echo Tip FNA Needle
Device: Fine needle biopsy
FNB
Other Name: Echo Tip Procore
Active Comparator: Fine needle biopsy
Fine needle biopsy
Device: Fine needle aspiration
Fine needle aspiration
Other Name: Echo Tip FNA Needle
Device: Fine needle biopsy
FNB
Other Name: Echo Tip Procore

Detailed Description:

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.

We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sri Komanduri, Associate Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01769248     History of Changes
Other Study ID Numbers: FNAFNBmucin
First Submitted: January 10, 2013
First Posted: January 16, 2013
Results First Submitted: March 5, 2015
Results First Posted: March 18, 2015
Last Update Posted: July 12, 2017
Last Verified: June 2017

Keywords provided by Sri Komanduri, Northwestern University:
EUS
FNA
FNB

Additional relevant MeSH terms:
Pancreatic Neoplasms
Gastrointestinal Stromal Tumors
Lymphadenopathy
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Lymphatic Diseases