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

Lymphadenopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01698190
• Other study ID #: SBUGI-2012
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2012
• Last updated: November 18, 2014
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: Stony Brook University
• Contact: Satish Nagula, M.D.
• Phone: 631-444-2119
• Email: satish.nagula[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Endoscopic ultrasound guided needle tissue acquisition.
Endoscopic ultrasound with fine needle aspiration (FNA) allows for the safe and efficacious sampling of solid lesions that are in close proximity to the gastrointestinal tract, including extraintestinal masses, subepithelial tumors, and peri-intestinal lymphadenopathy. Fine needle core biopsy (FNB) has the potential of accruing larger tissue samples during biopsies, which may make the procedure more efficacious. In our study, we are comparing the overall efficacy between these two needles which are currently both used as standard of care.

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (6)

Lead Sponsor	Collaborator
Stony Brook University	Columbia University, Icahn School of Medicine at Mount Sinai, New York Medical College, Weill Medical College of Cornell University, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (7)

ASGE Standards of Practice Committee, Gan SI, Rajan E, Adler DG, Baron TH, Anderson MA, Cash BD, Davila RE, Dominitz JA, Harrison ME 3rd, Ikenberry SO, Lichtenstein D, Qureshi W, Shen B, Zuckerman M, Fanelli RD, Lee KK, Van Guilder T. Role of EUS. Gastrointest Endosc. 2007 Sep;66(3):425-34. Epub 2007 Jul 23. Review. — View Citation

Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24. — View Citation

Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. — View Citation

Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I, Larino-Noia J, Eugenyeva E, Lozano-Leon A, Forteza-Vila J. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol. 2011 Sep;106(9):1705-10. doi: 10.1038/ajg.2011.119. Epub 2011 Apr 12. — View Citation

Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Muñoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21. — View Citation

Schwartz DA, Unni KK, Levy MJ, Clain JE, Wiersema MJ. The rate of false-positive results with EUS-guided fine-needle aspiration. Gastrointest Endosc. 2002 Dec;56(6):868-72. — View Citation

Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of needle passes needed to obtain a pathologic diagnosis.		Within 1 week of study enrollment	No
Secondary	Diagnostic yield, defined as percentage of cases with a diagnostic biopsy sample, between FNA and FNB.		By three months post-op in the pathology report	No
Secondary	Visible core specimens obtained and its correlation to obtaining a diagnostic sample.		During the intervention itself	No
Secondary	Frequency of adverse side effects.		Three months post-op	Yes