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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Stony Brook University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
New York Medical College
Yale University
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Stony Brook University
ClinicalTrials.gov Identifier:
NCT01698190
First received: May 25, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Pancreatic Tumor
Gastric Tumor
Esophageal Tumor
Lymphadenopathy
Duodenal Tumor
Procedure: Endoscopic ultrasound guided needle tissue acquisition.

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

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Number of needle passes needed to obtain a pathologic diagnosis. [ Time Frame: Within 1 week of study enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnostic yield, defined as percentage of cases with a diagnostic biopsy sample, between FNA and FNB. [ Time Frame: By three months post-op in the pathology report ] [ Designated as safety issue: No ]
  • Visible core specimens obtained and its correlation to obtaining a diagnostic sample. [ Time Frame: During the intervention itself ] [ Designated as safety issue: No ]
  • Frequency of adverse side effects. [ Time Frame: Three months post-op ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fine needle aspiration (FNA)
Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a standard FNA needle
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.
Other Name: Echotip ProCore
Active Comparator: Fine needle biopsy (FNB)
Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a new Core needle (Procore; Fine Needle Biopsy).
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.
Other Name: Echotip ProCore

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698190

Contacts
Contact: Satish Nagula, M.D. 631-444-2119 satish.nagula@stonybrookmedicine.edu

Locations
United States, New York
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Principal Investigator: Satish Nagula, M.D.         
Sponsors and Collaborators
Stony Brook University
New York Medical College
Yale University
Mount Sinai School of Medicine
Investigators
Principal Investigator: Satish Nagula, MD Stony Brook University
  More Information

Publications:

Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT01698190     History of Changes
Other Study ID Numbers: SBUGI-2012
Study First Received: May 25, 2012
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Duodenal Neoplasms
Esophageal Neoplasms
Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Duodenal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Pancreatic Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on October 23, 2014