Clinical Trials Logo

Clinical Trial Summary

We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield than core biopsy.


Clinical Trial Description

Background: Endoscopic ultrasonography (EUS) has been utilized for over a decade to evaluate endo-luminal and adjacent tumors of the gastrointestinal tract. In that time, EUS guided fine needle aspiration (FNA) has emerged as the dominant means of tissue acquisition for pancreatic mass lesions. FNA has several limitations, foremost of which is the absence of a clear relationship between cellular elements and stroma which may be required for accurate diagnosis. Additionally, EUS-FNA requires the assistance of an on-site cytopathologist for optimal yield which limits its dissemination and increases its cost. A novel EUS histology needle (EUS-FNB) is available in the 22 gauge diameter which may allow for more accurate diagnosis without the need for on site cytopathology assistance. Aim: To prospectively compare the diagnostic yield, number of needle passes, and ease of use of 22 gauge EUS-FNA and EUS-FNB. Hypothesis: EUS-FNB is superior to traditional EUS-FNA with regard to all primary and secondary outcome measures. Methods: Patients scheduled for EUS evaluation of solid pancreatic tumors will be screened for enrollment at either a preceding clinical encounter or the morning of their scheduled procedure. English-speaking patients between the ages of 18 and 90 with a predominantly solid (greater than 60%) mass lesion of the pancreas will be considered for enrollment. Exclusion criteria include pregnancy, a predominantly cystic lesion, and the presence of an uncorrectable coagulopathy. Patients will then undergo both EUS-FNA and EUS-FNB for the collection of tissue specimens required for clinical care. The results of the experimental approach (EUS-FNB) will be compared to the control approach (EUS-FNA). Data collected for each procedure will include: instrument use order, number of needle passes with each device, technical success of each device, complications, ease of use, and the ultimate pathological diagnosis / diagnostic yield for each device. Each data category will then be compared utilizing standard statistical tests including chi-squared, Fishers' exact, or student's t test. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01673334
Study type Interventional
Source University of Virginia
Contact
Status Completed
Phase Phase 4
Start date September 2011
Completion date July 9, 2013

See also
  Status Clinical Trial Phase
Recruiting NCT01978808 - Efficiency Study of the EUS-FNA Needles With and Without a Side Port in Pancreatic Masses N/A
Completed NCT01479803 - Comparison of Two Needles (ProCore vs EchoTip) for the Diagnosis of Pancreatic Solid Mass Under EUS Phase 3
Completed NCT02716207 - Phase ǀ Study on Pancreatic Cancer Treated by CyberKnife N/A
Withdrawn NCT01434550 - Phase II Study of First-line SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer N/A
Completed NCT03444051 - Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors N/A
Recruiting NCT05794048 - METabolic PROFILE of Hepatocarcinoma and Pancreatic Tumors N/A
Recruiting NCT05871164 - Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency
Recruiting NCT03558945 - Clinical Trial on Personalized Neoantigen Vaccine for Pancreatic Tumor Phase 1
Recruiting NCT01969110 - Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy Phase 4
Completed NCT02330497 - Efficacy and Safety of Radiofrequency Ablation in Pancreatic Neuroendocrine and Cystic Tumor N/A
Completed NCT01692873 - Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors N/A
Recruiting NCT04075305 - The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Recruiting NCT04357483 - Effect of Thrombin-containing Collagen-based Hemostatic Matrix Phase 4
Recruiting NCT01698190 - Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions N/A
Completed NCT03340844 - Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors N/A
Withdrawn NCT02534246 - Head to Head Comparison of Two Needles EUS Guided FNB N/A
Not yet recruiting NCT01819961 - Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery Phase 4
Withdrawn NCT02269683 - Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer N/A