Recruiting

Endoscopic FNA vs FNB

Sponsor:

Stony Brook University

Code:

NCT01698190

Conditions

Pancreatic Tumor

Gastric Tumor

Esophageal Tumor

Lymphadenopathy

Duodenal Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic ultrasound guided needle tissue acquisition.

Study Details

Brief 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.

Conditions

Pancreatic Tumor

Gastric Tumor

Esophageal Tumor

Lymphadenopathy

Duodenal Tumor

Study ID

NCT01698190

Start date

Dec, 2011

Status verified date

Nov, 2014

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Fine needle aspiration (FNA)

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

active comparator: Fine needle biopsy (FNB)

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

Interventions

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.

Primary outcome measure

  • Number of needle passes needed to obtain a pathologic diagnosis. [ Time Frame: Within 1 week of study enrollment ]

Central Contacts and Locations

Central contacts

Satish Nagula, M.D.

631-444-2119satish.nagula@stonybrookmedicine.edu

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Principal Investigator:

Satish Nagula, M.D.

More Information

Sponsor

Stony Brook University

Last update posted

Nov 19, 2014

Last verified

Nov, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2014-11-19.