Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions
Conditions
Pancreatic Tumor - Gastric Tumor - Esophageal Tumor - Lymphadenopathy - Duodenal Tumor
Conditions: official terms
Duodenal Neoplasms - Esophageal Neoplasms - Pancreatic Neoplasms - Stomach Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Intervention
Name: Endoscopic ultrasound guided needle tissue acquisition.
Type: Procedure
Overall Status
Recruiting
Summary
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Stony Brook University Hospital
Stony Brook, New York, United States
Status: Recruiting
Start Date
December 2011
Completion Date
December 2014
Sponsors
Stony Brook University
Source
Stony Brook University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page