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

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

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.

The patient undergoing the procedure, research coordinator calling patients for follow-up and the pathologist performing molecular profiling will be blinded to the randomization group.

Once the pancreatic mass is identified on endoscopic ultrasound examination, total of two passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.

Once the pancreatic mass is identified on endoscopic ultrasound examination, total of three passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.

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.

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.

Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy

Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy of pancreatic adenocarcinoma, with comparison between two and three passes during fine needle biopsy

Rate of technical success of EUS-guided fine needle biopsy. Technical success is defined as the successful completion of the EUS-guided fine needle biopsy procedure.

Rate of procedure-related adverse events, defined as any adverse event occurring as a result of EUS-guided fine needle biopsy

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