Prospective Study for Comparison of Endoscopic Ultrasound-Guided Tissue Acquisition Using 25- and 22-Gauge Core Biopsy Needles in Solid Pancreatic Masses

Abstract

Background and aims: Although thicker needles theoretically allow more tissue to be collected, their decreased flexibility can cause mechanical damage to the endoscope, technical failure, and sample blood contamination. The effects of needle gauge on diagnostic outcomes of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) of pancreatic mass lesions remain unknown. This study compared procurement rates of histologic cores obtained from EUS-FNB of pancreatic masses using 25- and 22-gauge core biopsy needles.

Patients and methods: From March 2014 to July 2014, 66 patients with solid pancreatic mass underwent EUS-FNB with both 25- and 22-gauge core biopsy needles. Among them, 10 patients were excluded and thus 56 patients were eligible for the analyses. Needle sequences were randomly assigned, and two passes were made with each needle, consisting of 10 uniform to-and-fro movements on each pass with 10 mL syringe suction. A pathologist blinded to needle sequence evaluated specimens for the presence of histologic core.

Results: The mean patient age was 65.8 ± 9.5 years (range, 44-89 years); 35 patients (62.5%) were men. The mean pancreatic mass size was 35.3 ± 17.1 mm (range 14-122.3 mm). Twenty-eight patients (50%) had tumors at the pancreas head or uncinate process. There were no significant differences in procurement rates of histologic cores between 25-gauge (49/56, 87.5%) and 22-gauge (46/56, 82.1%, P = 0.581) needles or diagnostic accuracy using only histologic cores (98% and 95%). There were no technical failures or procedure-related adverse events.

Conclusions: The 25-gauge core biopsy needle could offer acceptable and comparable outcomes regarding diagnostic performance including histologic core procurement rates compared to the 22-gauge core biopsy needle, although the differences were not statistically significant.

Trial registration: ClinicalTrials.gov NCT01795066.

Fig 1. CONSORT Flow diagram of patients throughout the randomized trial.

A total of 66 patients were enrolled and underwent initial EUS-FNB with 22-gauge or 25-gauge needle in random sequence. Ten patients were excluded for noncompliance with the scheduled examinations. Among them, the target lesion could not be reached because of anatomical alterations due to previous surgery (e.g., maxillary reconstruction, subtotal gastrectomy with Billroth II reconstruction, or total gastrectomy with Roux en Y reconstruction) in 5 patients, significant duodenal stricture as a result of tumor infiltration in 1 patient, and collateral intervening vessels in 2 patients. Two patients were excluded because the target lesions could not be endosonographically visualized. Thus, a total of 56 patients were eligible for the analyses. In total, 28 patients each initially underwent EUS-FNB with 22-gauge and 25-gauge needles. No patient experienced technical problems (difficult procedure or needle malfunction), after excluding the aforementioned 10 patients from the 66 total patients.