Randomized Trial to Evaluate the Optimal Number of Passes Required for Molecular Profiling During Endoscopic Ultrasound-guided Fine Needle Biopsy of Pancreatic Adenocarcinoma

  • End date
    Jun 30, 2023
  • participants needed
  • sponsor
    Orlando Health, Inc.
Updated on 28 October 2022
endoscopic ultrasound
fine needle biopsy


This is a randomized trial to evaluate the optimal number of passes required during endoscopic ultrasound-guided fine needle biopsy for molecular profiling in pancreatic cancer


Endoscopic ultrasound-guided fine needle tissue acquisition is currently the gold standard for sampling solid pancreatic masses. By using novel fine needle biopsy (FNB) needles during EUS-guided tissue sampling, core tissue samples can also now be obtained, with diagnostic adequacy of >90%.

Molecular profiling is becoming increasingly important in the management of pancreatic adenocarcinoma for targeted therapy. As the procurement of core tissue is possible with EUS-FNB, adequate tissue can now be obtained for molecular profiling. However, the number of passes required during EUS-FNB to obtain sufficient quantity of core tissue to successfully perform molecular profiling is unknown, although usually 2-3 passes are performed as standard of care practice.

The primary aim of this study is therefore to elucidate the optimal number of passes required during EUS-FNB to procure adequate tissue for molecular profiling in patients with pancreatic adenocarcinoma.

Condition Pancreatic Cancer, Pancreatic Neoplasms, Adenocarcinoma of the Pancreas
Treatment 2 passes during EUS-guided fine needle biopsy, 3 passes during EUS-guided fine needle biopsy
Clinical Study IdentifierNCT05043532
SponsorOrlando Health, Inc.
Last Modified on28 October 2022


Yes No Not Sure

Inclusion Criteria

Age 18 years and over
Suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy

Exclusion Criteria

Age < 18 years
Females who are pregnant
Pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound
Biopsied pancreatic mass is not adenocarcinoma on pathology
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