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

NCT07032974 | Recruiting DMC

• 1 other identifier: Si 316/2022
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pancreatic mass; EUS; EUS-FNB; Fine needle biopsy; Endoscopic ultrasound; Pancreatic lesion

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Diagnostic accuracy of three third-generation fine-needle biopsy (FNB) needles

  6 months

Secondary Outcomes (4)

• Number of needle passes

  During procedure

• Overall satisfaction

  During procedure

• Procedure time

  During procedure

• Adverse events

  up to 2 weeks

Study Arms (3)

Franseen

EXPERIMENTAL

Device: Franseen

Forward- bevel

EXPERIMENTAL

Device: Forward-bevel

Fork-tip

EXPERIMENTAL

Device: Fork-tip

Interventions

Franseen DEVICE

Franseen needle

Franseen

Forward-bevel DEVICE

Forward-bevel needle

Forward- bevel

Fork-tip DEVICE

Fork-tip needle

Fork-tip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Study Officials

• Varayu Prachayakul, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronnakorn Kongsakon, MD

CONTACT

+66655979522; ronnagorn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Other researchers can contact us anytime.
• Access Criteria: We will provide our protocol and/or data upon request.

Locations

TH (1)