Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions

Stony Brook University

Status: Unknown

Conditions: Duodenal Tumor; Esophageal Tumor; Gastric Tumor; Pancreatic Tumor; Lymphadenopathy

Treatments: Procedure: Endoscopic ultrasound guided needle tissue acquisition.

Study type: Interventional

Funder types: Other

Identifiers

NCT01698190

SBUGI-2012

Details and patient eligibility

About

The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is more efficacious and cost-effective than the other while maintaining diagnostic accuracy in the setting of solid gastrointestinal lesions.

Full description

When ultrasound is used during endoscopy, we are able to visualize the structures adjacent to the gastrointestinal tract in close detail. Once the mass is visualized, we use endoscopic ultrasound to obtain a tissue sample, which the pathologist can examine in order to provide a diagnosis.

The conventional method for obtaining a sample of tissue with endoscopic ultrasound is called fine needle aspiration (FNA). This involves the insertion of a thin needle into the mass and obtaining a small sample of tissue which the pathologist can examine. An alternative technique is called fine needle biopsy (FNB), and involves the insertion of a thin double-edged needle into the mass. This double-edged needle may potentially provide a larger sample of tissue to examine.

Both of these techniques are commonly used, and both methods are equally safe. However, it is not known if one of these techniques is more effective at obtaining a sample of tissue or if one of these techniques is more cost-effective than the other. The purpose of this study is to determine if one method is more efficacious and cost-effective than the other while maintaining diagnostic accuracy. The results of this study may alter the way gastroenterologists obtain tissue samples during endoscopic ultrasound, improving the utility of the exam and reducing unnecessary healthcare costs.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive adult patients who require endoscopic ultrasound and tissue sampling of either a) pancreatic solid lesion, b) subepithelial solid lesion of the esophagus, stomach, duodenum or rectum, c) liver lesion, or d) lymph nodes or mass lesion located adjacent to the esophagus, stomach, duodenum or rectum
• Ability to give consent

Exclusion criteria

• Inability to obtain informed consent
• Pregnant patients
• Patients under the age of 18
• Severe cardiopulmonary disease preventing a safe EUS procedure
• Patients unable to safely stop anti-coagulation therapy prior to EUS procedure

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Fine needle aspiration (FNA)

Active Comparator group

Description:

Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a standard FNA needle

Treatment:

Procedure: Endoscopic ultrasound guided needle tissue acquisition.

Fine needle biopsy (FNB)

Active Comparator group

Description:

Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a new Core needle (Procore; Fine Needle Biopsy).

Treatment:

Procedure: Endoscopic ultrasound guided needle tissue acquisition.