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

• ClinicalTrials.gov Identifier: NCT01769248
• Recruitment Status: Completed
• First Posted: January 16, 2013
• Results First Posted: March 18, 2015
• Last Update Posted: January 18, 2018
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Sri Komanduri, Northwestern University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pancreatic Cancer; Lymphadenopathy; Gastrointestinal Stromal Tumor	Device: Fine needle aspiration; Device: Fine needle biopsy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• 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
• Study Start Date: September 2012
• Actual Primary Completion Date: February 2014
• Actual Study Completion Date: February 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Diagnostic Yield of EUS-FNB and EUS-FNA [ 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: FNAFNBmucin
• First Posted: January 16, 2013
• Results First Posted: March 18, 2015
• Last Update Posted: January 18, 2018
• Last Verified: December 2017

Keywords provided by Sri Komanduri, Northwestern University:

EUS; FNA; FNB

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors; Lymphadenopathy; Digestive System Neoplasms; Neoplasms; Digestive System Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Lymphatic Diseases