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Comparing the Overall Efficacy of Endoscopic Ultrasound Fine Needle Aspiration Versus Fine Needle Biopsy in the Diagnosis of Solid Lesions: A Multicenter, Randomized Clinical Trial


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Tumor, Gastric Tumor, Esophageal Tumor, Lymphadenopathy, Duodenal Tumor

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Trial Information

Comparing the Overall Efficacy of Endoscopic Ultrasound Fine Needle Aspiration Versus Fine Needle Biopsy in the Diagnosis of Solid Lesions: A Multicenter, Randomized Clinical Trial


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

Number of needle passes needed to obtain a pathologic diagnosis.

Outcome Time Frame:

Within 1 week of study enrollment

Safety Issue:

No

Principal Investigator

Satish Nagula, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stony Brook University

Authority:

United States: Institutional Review Board

Study ID:

SBUGI-2012

NCT ID:

NCT01698190

Start Date:

December 2011

Completion Date:

December 2012

Related Keywords:

  • Pancreatic Tumor
  • Gastric Tumor
  • Esophageal Tumor
  • Lymphadenopathy
  • Duodenal Tumor
  • Duodenal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Lymphatic Diseases

Name

Location

Stony Brook University HospitalStony Brook, New York  11794-8174