For patients with pancreatic masses, infiltrated lymph nodes, or submucosal tumors, endoscopic ultrasound-guided fine-needle aspirate and fine-needle biopsy produced a comparable diagnostic yield with a similar number of needle passes, according to the results of a multicenter, randomized clinical trial.
Diagnostic yields were 91% for fine-needle aspirate versus 89% for fine-needle biopsy, with a median of one needle pass needed to obtain a diagnostic sample for each technique, reported Satish Nagula, MD, of the Icahn School of Medicine at Mount Sinai, New York, and his associates. The findings were published in theof Clinical Gastroenterology and Hepatology.
Previously, two small, single-center randomized trials yielded conflicting data on whether fine-needle biopsy produces better diagnostic yield than fine-needle aspirate, the investigators noted. The results of four other studies indicated that the two techniques performed similarly. However, “many of these trials had study designs that did not allow for realistic comparisons of needle performance,” they noted. For example, the studies only analyzed the results of the first needle pass or only included specimens with visible core tissue.
The current study included six tertiary care centers that perform high volumes of endoscopic ultrasound. In all, 135 patients were randomly assigned to undergo fine-needle aspirate or fine-needle biopsy. When rapid on-site cytologic evaluation was used, the clinicians made consecutive needle passes until they considered the specimen adequate. Most lesions (77%) were masses, but 17% were lymph nodes, and 7% were submucosal tumors, the researchers said. The endoscopists used a curvilinear array echoendoscope (GF-UC140P or GF-UCT140; Olympus America, Central Valley, Penn.). They performed fine-needle aspirate or biopsy by using either a 22-gauge or 25-gauge needle at their own discretion.
The final diagnosis was malignancy for 70% of lesions, reactive lymphadenopathy for 11% of lesions, and spindle cell tumors in 9% of cases, the investigators said. Diagnostic yield was similar whether or not rapid on-site cytologic evaluation was used. Fine-needle aspiration detected cancer with a sensitivity of 90% and a specificity of 100%. Fine-needle biopsy had a sensitivity of 89% and a specificity of 100%. Adverse events were uncommon (1%), but one patient was hospitalized with pancreatitis for 2 days after undergoing fine-needle biopsy of a pancreatic body lesion.
The researchers noted several study limitations. “Ideally, each patient would undergo both fine-needle aspirate and fine-needle biopsy, allowing each as their own internal control,” they wrote. “It was considered too expensive to use two different needles in this unfunded study.” There also was no central pathology review, which they called “fiscally not feasible.”
There were no funding sources, and the investigators reported having no relevant conflicts of interest.SOURCE: Nagula S et al. Clin Gastroenterol Hepatol. 2017 Jun 14. .