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

Pancreatic Cancer Clinical Trial

— MUCIN  

Official title:

Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769248
• Other study ID #: FNAFNBmucin
• Status: Completed
• Phase: N/A
• First received: January 10, 2013
• Last updated: December 19, 2017
• Start date: September 2012
• Est. completion date: February 2014

Study information

• Verified date: December 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Lymphadenopathy
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• Fine needle aspiration
Fine needle aspiration
• Fine needle biopsy
FNB

Locations

Country	Name	City	State
United States	UCLA Medical Center	Los Angeles	California
United States	California Pacific Medical Center	San Francisco	California
United States	Moffit Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Yield of EUS-FNB and EUS-FNA	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.	1 year
Secondary	Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB	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	1 year
Secondary	Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)	As above. Crossover to FNA or FNB occurs after 3 passes without adequate material	1 yr