NCT05043532

Randomized Trial for Optimal Number of Passes Required for Molecular Profiling During EUS-FNB of Pancreatic Cancer

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Orlando Health, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pancreatic Cancer
• Pancreatic Neoplasms
• Adenocarcinoma of the Pancreas

Interventions

Type	Name	Description
PROCEDURE	2 passes during EUS-guided fine needle biopsy	Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of two passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.
PROCEDURE	3 passes during EUS-guided fine needle biopsy	Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of three passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.

Timeline

• Start date: 2021-08-18
• Primary completion: 2023-03-01
• Completion: 2023-06-30
• First posted: 2021-09-14
• Last updated: 2023-01-12

Locations

1 site across 1 country: United States