EUS-guided core biopsies of pancreatic solid masses using a new fork-tip needle: A multicenter prospective study

Area of Science:

• Gastroenterology
• Endoscopic Ultrasound
• Pancreatic Pathology

Background:

• Endoscopic ultrasound-guided sampling (EUS sampling) is a recognized safe and effective diagnostic procedure.
• Pancreatic lesions require accurate histological diagnosis for appropriate management.
• Evaluating novel sampling tools is crucial for improving diagnostic yield.

Purpose of the Study:

• To assess the efficacy of a new 25-gauge (25G) fork-tip needle for obtaining histological cores from pancreatic lesions.
• To determine the histological core procurement rates using the 25G fork-tip needle in EUS-guided sampling.
• To evaluate the diagnostic adequacy and safety of this new needle.

Main Methods:

• An observational, multicenter, prospective study involving patients with solid pancreatic masses undergoing EUS-guided sampling.
• Use of a novel 25G fork-tip needle for tissue acquisition.
• Macroscopic on-site evaluation (MOSE) performed by endoscopists at each needle pass.
• Assessment of primary outcome: histological core procurement rates.
• Secondary outcomes included interobserver agreement, sample adequacy for diagnosis, and adverse events.

Main Results:

• 100 patients with pancreatic masses (mean size 28.5 mm) were analyzed.
• Histological cores were procured in 67.0% of patients.
• The diagnostic accuracy of EUS samples was 93%.
• Mild adverse events occurred in 6% of patients; no major complications were reported.
• Interobserver agreement between endoscopists and pathologists for MOSE was poor (kappa=0.12).

Conclusions:

• The 25G fork-tip needle is effective for obtaining histological specimens during EUS sampling of solid pancreatic masses.
• The technique demonstrated good overall adequacy and a favorable safety profile with minimal complications.
• The study supports the utility of this new needle for improving diagnostic yield in pancreatic lesion sampling.