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NCT Number: NCT01769248

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumor Gastrointestinal Stromal Tumors Hemic and Lymphatic Diseases Lymphadenopathy Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fine needle aspiration

Device

Fine needle aspiration

Other names: Echo Tip FNA Needle

Fine needle biopsy

Device

FNB

Other names: Echo Tip Procore

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Acronym: MUCIN

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 16, 2013
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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