RCT Comparing Accuracy Among Franseen, Forward-bevel Westcott, and Fork-tip EUS-FNB Needle in Diagnosis of Solid Pancreatic Lesions

Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA) for pancreatic tissue acquisition is a widely accepted and popularly used technique because of its high diagnostic accuracy of 78% - 95% and a low risk of adverse events.

Previous studies have tried to identify ways to increase the efficacy and diagnostic accuracy of EUS-FNA. Many factors were found to influence the diagnostic accuracy of EUS-FNA which included needle size, sampling technique, evaluation of tissue adequacy, number of needle passes, and finally the needle type, which the impact of most of the aforementioned factors were thoroughly studied and already incorporated into the standard practice of pancreatic tissue acquisition.

It was difficult to diagnose some pancreatic diseases by EUS-FNA, such as lymphoma, gastrointestinal stromal tumor (GIST), and autoimmune pancreatitis because the cytologic specimen was simply not enough for further ancillary studies. FNB needles were subsequently developed to eliminate this limitation, by obtaining a larger specimen, FNB needles enable pathologists to evaluate the specimens more thoroughly and help guide further therapeutic decisions. In addition, it reduces the dependency on immediate cytological examination during endoscopy (Rapid on-site evaluation [ROSE]) and also reduces the procedure duration, since the number of needle passes is reduced.

The continuous development of EUS-FNB needles has been a major area of interest in recent years. In particular, the third generation of FNB needles were developed to obtain a more adequate tissue sample. Previous research has focused on comparing the accuracy of the second generation FNB needles with the FNA needles in the diagnosis of pancreatic tissue. Results from these studies found no significant differences between the two needles. However, it was discovered that the third generation FNB needle has significantly higher diagnostic accuracy than the FNA needle. These findings suggest that the third generation FNB needle may be a more reliable and effective tool for diagnosing tissue samples in various clinical settings.

In the field of tissue biopsy, the third generation FNB needle is currently available in three types based on the characteristics of the needle tip. These types include Franseen geometry needle (Acquire, Boston Scientific), Fork-tip needle (Shark-core, Medtronic), and Forward-bevel Westcott (Procore, Cook Medical). However, there is a lack of research comparing the diagnostic accuracy of among each type of needle. Only two randomized controlled trials have been conducted to address this issue. Karsenti et al. investigated the accuracy of diagnosing a pancreatic mass using Franseen geometry needle (Acquire, Boston Scientific) and Forward-bevel Westcott (Procore, Cook Medical). The study found accuracy rates of 87% (75-94) and 67% (53-78), respectively, with a p-value of 0.02. Ashat et al. compared the accuracy of diagnosing all gastrointestinal masses using Franseen geometry needle (Acquire, Boston Scientific) and Fork-tip needle (Shark-core, Medtronic), finding accuracy rates of 85.3% and 90.7%, respectively, with a p-value of 0.45. Subgroup analysis for pancreatic masses alone found accuracy rates of 89.7% and 94.4%, respectively, with a p-value of 0.68.

In the context of diagnosing pancreatic tissue masses, only a limited number of studies have examined the comparative accuracy of 3rd generation fine needle biopsy (FNB) needles. As such, it remains unclear which type of needle can deliver superior diagnostic precision, and to date, no study has conducted a head-to-head comparison of all three needle types. Thus, the purpose of the present investigation is to assess the diagnostic accuracy of all three 3rd generation FNB needle types in the context of detecting pancreatic tumors.

Inclusion criteria

• Age > 18 years
• Solid pancreatic mass greater than 1 cm in size who required tissue diagnosis

Exclusion criteria

• Pregnancy
• Uncorrected coagulopathy
• Surgically altered anatomy
• Unable to complete informed consent