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

Summary

Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA) is a well-established technique for pancreatic tissue acquisition, offering a high diagnostic accuracy ranging from 78% to 95%, along with a favorable safety profile. Over time, numerous studies have sought to optimize this procedure by investigating various contributing factors, including needle size, sampling techniques, adequacy of tissue acquisition, the number of passes required, and needle type. These insights have largely been incorporated into routine clinical practice, refining the diagnostic capabilities of EUS-FNA.

Despite its widespread use, EUS-FNA has limitations, particularly in the diagnosis of certain pancreatic pathologies such as lymphoma, gastrointestinal stromal tumors (GISTs), and autoimmune pancreatitis. These conditions often require histologic samples for ancillary studies, which cytologic specimens obtained via FNA cannot sufficiently provide. To overcome this limitation, Fine Needle Biopsy (FNB) needles were developed. These needles enable the procurement of core tissue samples, thereby enhancing histopathological assessment and reducing reliance on rapid on-site cytological evaluation (ROSE). Additionally, FNB allows for fewer needle passes, which can shorten procedure time and reduce associated complications.

Among FNB technologies, the third generation of needles has garnered particular attention due to improved sample adequacy and diagnostic reliability. While earlier research compared second-generation FNB needles with FNA, demonstrating no significant difference in diagnostic yield, more recent studies suggest that third-generation FNB needles offer superior diagnostic accuracy.

Currently, three distinct third-generation FNB needle types are commercially available, distinguished by their tip geometry:

Franseen geometry - Acquire™ (Boston Scientific)

Fork-tip - SharkCore™ (Medtronic)

Forward-bevel Westcott - ProCore™ (Cook Medical)

Despite their clinical adoption, comparative data on their diagnostic performance remain scarce. Only two randomized controlled trials (RCTs) have directly compared these needle types:

Karsenti et al. compared the Franseen (Acquire) and the Forward-bevel Westcott (ProCore) needles for pancreatic mass diagnosis. Diagnostic accuracy was 87% (CI: 75-94) for the Franseen needle and 67% (CI: 53-78) for the Westcott needle, with a statistically significant difference (p = 0.02).

Ashat et al. evaluated the Franseen (Acquire) and Fork-tip (SharkCore) needles in diagnosing all gastrointestinal masses, reporting diagnostic accuracies of 85.3% and 90.7%, respectively (p = 0.45). In a pancreatic mass-specific subgroup analysis, accuracy rates were 89.7% and 94.4%, respectively (p = 0.68), suggesting comparable performance between the two.

Despite these findings, the current literature does not include a comprehensive head-to-head comparison encompassing all three third-generation FNB needle types. Therefore, it remains uncertain which design offers the best diagnostic performance for pancreatic tumors. The absence of such comparative studies presents a significant gap in the field of EUS-guided tissue acquisition.

Conditions

• Pancreatic Masses

Interventions

DEVICE

Franseen

Franseen needle

DEVICE

Forward-bevel

Forward-bevel needle

DEVICE

Fork-tip

Fork-tip needle

Sponsors & Collaborators

• Mahidol University

  lead OTHER

Principal Investigators

• Varayu Prachayakul, MD · Siriraj Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2026-07-31

Completion

2026-07-31

Countries

• Thailand

Study Locations