Contrast-enhanced harmonic versus standard endoscopic ultrasound-guided fine-needle aspiration in solid pancreatic lesions: a single-center prospective randomized trial

Abstract

<jats:title>Abstract</jats:title><jats:p> Background Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) can visualize necrotic areas and vessels inside lesions. CH-EUS findings combined with EUS-guided fine-needle aspiration (EUS-FNA) improves diagnosis in pancreatic solid masses. CH-EUS can also guide EUS-FNA (CH-EUS-FNA), potentially improving the diagnostic rate of EUS-FNA, but such superiority has not been proved in prospective studies. We aimed to assess whether CH-EUS-FNA is superior to standard EUS-FNA for specific diagnosis of solid pancreatic masses and what factors affect the diagnostic rate. </jats:p><jats:p> Methods This randomized controlled study in one tertiary medical academic center included patients with suspected pancreatic solid masses on transabdominal ultrasound or computed tomography (CT) scan. Two passes with a 22-G standard FNA needle were done using EUS-FNA and CH-EUS-FNA in random order, and the visible core obtained was sent for histological analysis. Final diagnosis was based on EUS-FNA or surgical specimen results and on 12-month follow-up by imaging. </jats:p><jats:p> Results 148 patients were evaluated. EUS-FNA and CH-EUS-FNA showed diagnostic sensitivities of 85.5 % and 87.6 %, respectively (not significantly different) and the combined sensitivity of the two passes was 93.8 %. The false-negative rate was not significantly different when hypoenhanced or hyperenhanced lesions were compared with the EUS-FNA results. No differences were seen for the results related to location, size, tumor stage, chronic pancreatitis features, or presence of biliary plastic stent. </jats:p><jats:p> Conclusions The diagnostic rates for samples obtained using 22-G needles with standard EUS-FNA and CH-EUS-FNA were not statistically significantly different. </jats:p>

Contrast-Enhanced Harmonic Endoscopic Ultrasound-Guided Fine-Needle Aspiration versus Standard Fine-Needle Aspiration in Pancreatic Masses: A Propensity Score Analysis

“…In particular, diagnostic sensitivity was 87.6% in Group 1 and 80% in Group 2 ( p = 0.18) and diagnostic accuracy was 89.3% and 82.5% in the two groups, respectively ( p = 0.11). These results are in line with previous reports [ 10 , 17 ] and confirm that CH-EUS-FNA is not able to significantly increase the performance of EUS-FNA in patients with solid pancreatic lesions. As expected, specificity and positive predictive values were 100% in both groups.…”

“…Targeting FNA based on the contrast enhancement pattern could reasonably be considered able to decrease the number of needle passes needed to obtain adequate samples; instead, no difference concerning this parameter was observed in our study (2.4 ± 0.6 and 2.7 ± 0.8, respectively; p = 0.76), again in line with the current literature [ 10 , 17 , 18 ].…”

“…According to the current guidelines, two phases were described: a) the arterial phase, starting from around 10–20 s until around 35–40 s after contrast injection, and b) the venous phase, starting from around 30–45 s after contrast injection [ 25 ]. When a pancreatic lesion was diagnosed as pancreatic adenocarcinoma by CH-EUS, the hypoenhancement area of the lesion was selected as a target area for FNA ( Figure 1 ); on the other hand, when the CH-EUS diagnosis was focal pancreatitis or a neuroendocrine tumor, the iso- or hyperenhancement area of the lesion was selected, according to the current literature [ 10 , 11 , 16 , 17 , 18 ]. The FNA site was monitored simultaneously by endosonography.…”

“…In order to increase EUS-FNA sensitivity and accuracy for the evaluation of pancreatic masses, specific techniques already used in other fields (for instance in liver oncology) have been developed, such as real-time elastography EUS (RTE-EUS)-FNA [ 9 ] and contrast-enhanced harmonic EUS (CH-EUS)-FNA [ 10 , 11 ].…”

“…Five series directly compared CH-EUS-FNA to standard EUS-FNA [ 10 , 11 , 16 , 17 , 18 ], of which two randomized-controlled trials (RCTs) [ 10 , 16 ] have been published so far with conflicting results. Therefore, whether CH-EUS-FNA might lead to a significant increase in diagnostic sensitivity and accuracy as compared to EUS-FNA remains an open debate.…”