Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study

Abstract

Background and study aims The poor flexibility of large-bore EUS needles often leads to technical failure when sampling from the duodenum. The aim of this study was to evaluate the technical and diagnostic performances of a new Menghini tip 19G nitinol EUS needle for sampling pancreatic solid lesions in the head and uncinate process. Patients and methods This was a European prospective multicenter single-arm study. A maximum of four passes were allowed. In case of failure, different needles were permitted. Results We included 75 patients (51 % males) with lesions in the head (n = 68; 91 %) and uncinate process (n = 7; 9 %) (mean size: 33 ± 12 mm; number of passes: 1.8 ± 0.9). Technical success was seen in 71 of 75 (94.7 %). Diagnostic rates were 89.3 % (67/75) and 94.4 % (67/71) in the intention-to-treat (ITT) and per-protocol (PP) analysis, respectively. In the eight cases with failure, diagnosis was obtained with another needle (n = 4), from another lesion (n = 3) or with follow-up (n = 1). A histological sample was obtained in 64 patients (ITT 85.3 % and PP 90 %) and immunohistochemistry was successfully performed in 13 of 15 lesions in which it was required. No differences between rapid on-site evaluation (ROSE) and non-ROSE groups were observed regarding diagnostic success (87.5 % vs 91 %, P = 0.582) and diagnosis at the first pass (70 % vs 81 %, P = 0.289). Number of passes was lower in the ROSE group (1.4 + 0.9 vs 2.2 + 0.7, P < 0.001). One adverse event was recorded (1.3 %) consisting in a duodenal perforation after a single session EUS-ERCP. Conclusions The new nitinol Menghini tip 19G EUS needle showed high technical diagnostic success in safely sampling solid lesions in the head and uncinate process of the pancreas.

Cryo-Biopsy versus 19G needle versus 22G needle with EBUS-TBNA endoscopy

“…In a recent study it was observed that the 19G needle when compared to 22G needle has a larger sample size and it has a higher diagnostic sensitivity for lymphoma 19 , 20 . This information is in accordance with previous publications with the esophageal ultrasound (EUS) where the gastroenterologists used larger 19G needles 21 , 22 . However; based on the published literature regarding cryo biopsies for endobronchial lesions it was observed that larger samples were obtained 23 .…”

Endoscopic Ultrasound Through-The-Needle Biopsy of Pancreatic Cysts: Toward Procedure Standardization

“…In the single case of technical failure, concerning an uncinate process cyst, the endoscope/needle set position did not allow the forceps passage. The use of new nitinol-based needles with enhanced flexibility may be a solution to overcome this difficulty, but this should be a subject for future studies [19, 20]. The results from our series are similar to the experience of other groups [7, 9, 21, 22], with several recent meta-analyses confirming the favorable diagnostic accuracy of TTNB and its superiority over FNA cytology [12, 13, 18].…”

Comparison between EUS-guided fine-needle biopsy with or without rapid on-site evaluation for tissue sampling of solid pancreatic lesions: A systematic review and meta-analysis

“…From 3445 studies identified using the search strategy, we included 8 studies,[ 10 11 12 20 21 22 23 24 ] [ Figure 1 ] recruiting 2147 patients. Out of these 8 studies, 5 were retrospective series,[ 11 12 20 22 24 ] 2 RCTs,[ 10 23 ] and 1 study was a prospective series.…”

“…Out of these 8 studies, 5 were retrospective series,[ 11 12 20 22 24 ] 2 RCTs,[ 10 23 ] and 1 study was a prospective series. [ 21 ] Specifically, 1 large multicenter RCT[ 10 ] and 4 retrospective series[ 12 20 22 24 ] were studies focused on the direct comparison between EUS-FNB + ROSE versus EUS FNB alone, whereas another retrospective study[ 11 ] was a 4-arm retrospective series comparing EUS FNA alone versus EUS-FNA + ROSE versus EUS-FNB alone versus EUS-FNB + ROSE, the prospective series by Gines et al [ 21 ] and the RCT by Nagula et al [ 23 ] reported a subgroup analysis based on the use of ROSE. All the studies were published as full-text manuscripts except the retrospective study by Mahmood et al [ 24 ]…”

“…Mean lesion size was around 30 mm and most of the sampled masses were located in the head/uncinated process of the pancreas. Particularly, the study by Gines et al [ 21 ] recruited exclusively patients with lesions in the pancreatic head/uncinated process. Slow pull was used predominantly or exclusively in three studies.…”