Prospective Assessment of the Performance of a New Fine Needle Biopsy Device for EUS-Guided Sampling of Solid Lesions

Hajj, Ihab I. El; Wu, Howard H.; Reuss, Sarah M.; Randolph, Melissa; Harris, Akeem; Gromski, Mark A.; Al‐Haddad, Mohammad

doi:10.5946/ce.2018.053

Cited by 54 publications

(46 citation statements)

References 23 publications

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“…In contrast, a large study of solid masses (not specifically evaluating LNs) showed that FNB and lesion size were associated with the need to perform only one pass to achieve onsite diagnostic adequacy and were associated with acquisition of diagnostically adequate histological specimens for offsite assessment [ 15 ]. Additionally, the safety of EUS tissue sampling is well established, and a few or no adverse events have been reported in the literature [ 29 ]. Severe adverse events are very rare [ 6 , 23 , 30 ].…”

Section: Discussionmentioning

confidence: 99%

Endoscopic Ultrasound Fine-Needle Aspiration versus Fine-Needle Biopsy for Lymph Node Diagnosis: A Large Multicenter Comparative Analysis

et al. 2020

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Background/Aims: Endoscopic ultrasound fine-needle aspiration (EUS-FNA) is preferred for sampling of lymph nodes (LNs) adjacent to the gastrointestinal wall; however, fine-needle biopsy (FNB) may provide improved diagnostic outcomes. This study aimed to evaluate the comparative efficacy and safety of FNA versus FNB for LN sampling. Methods: This was a multicenter retrospective study of prospectively collected data to evaluate outcomes of EUS-FNA and EUS-FNB for LN sampling. Characteristics analyzed included sensitivity, specificity, accuracy, the number of needle passes, diagnostic adequacy of rapid on-site evaluation (ROSE), cell-block analysis, and adverse events. Results: A total of 209 patients underwent EUS-guided LN sampling. The mean lesion size was 16.22±8.03 mm, with similar sensitivity and accuracy between FNA and FNB ([67.21% vs. 75.00%, respectively, p=0.216] and [78.80% vs. 83.17%, respectively, p=0.423]). The specificity of FNB was better than that of FNA (100.00% vs. 93.62%, p=0.01). The number of passes required for diagnosis was not different. Abdominal and peri-hepatic LN location demonstrated FNB to have a higher sensitivity (81.08% vs. 64.71%, p=0.031 and 80.95% vs. 58.33%, p=0.023) and accuracy (88.14% vs. 75.29%, p=0.053 and 88.89% vs. 70.49%, p=0.038), respectively. ROSE was a significant predictor for accuracy (odds ratio, 5.16; 95% confidence interval, 1.15-23.08; p=0.032). No adverse events were reported in either cohort. Conclusions: Both EUS-FNA and EUS-FNB are safe for the diagnosis of LNs. EUS-FNB is preferred for abdominal LN sampling. EUS-FNA+ROSE was similar to EUS-FNB alone, showing better diagnosis for EUS-FNB than traditional FNA. While ROSE remained a significant predictor for accuracy, due to its poor availability in most centers, its use may be limited to cases with previous inconclusive diagnoses. Clin Endosc 2019 Dec 3. [Epub ahead of print]

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Section: Discussionmentioning

confidence: 99%

Endoscopic Ultrasound Fine-Needle Aspiration versus Fine-Needle Biopsy for Lymph Node Diagnosis: A Large Multicenter Comparative Analysis

et al. 2020

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“…An increase in AEs associated with use of the Franseen needle is a matter of concern because the structure of the tip may cause tissue injuries. In previous studies, bleeding [2,7], pancreatitis [10], and pancreatic fistula [14] were reported as AEs.…”

Section: Discussionmentioning

confidence: 99%

“…The Franseen needle, which has three symmetric heels at the tip [2], was recently developed to improve the quantity and quality of the samples obtained, and subsequently diagnostic yields, by preserving the structural integrity of the tissues. An experimental study in an animal model [3] showed that the Franseen needle has better tissue acquisition abilities of than conventional needles, and clinical studies on 22-gauge needles have also shown good results [2,[4][5][6][7][8][9][10][11]. However, it is sometimes relatively difficult to obtain a puncture with the Franseen needle because of the unique design of the tips.…”

Section: Introductionmentioning

confidence: 99%

Prospective evaluation of 25-gauge Franseen needles for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic masses

et al. 2020

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Background and study aims The ideal puncture needle for endoscopic ultrasound (EUS)-guided sampling is maneuverable and easy to puncture with, and can obtain sufficient material in almost one pass. The novel 25-gauge Franseen needle may provide a good balance between maneuverability and sample yield. Patients and methods Between July 2017 and December 2018, 116 patients with solid pancreatic masses were prospectively enrolled and investigated. We evaluated the diagnostic yield associated with using the 25-gauge Franseen needle for EUS-guided sampling of pancreatic masses. Results The technical success rate was 100 % (116/116). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for malignancy were 98 % (105/107), 100 % (9/9), 100 % (105/105), 82 % (9/11), and 98 % (114/116), respectively. Cumulative sensitivities for malignancy were 87 % (93/107) on pass 1, 97 % (104/107) on pass 2, and 98 % (105/107) on pass 3, respectively, with no increase in sensitivity after 4 or more. An adequate specimen for histological assessment was obtained in 79 % (92/116) of cases. Multivariate logistic analyses showed that lesion size smaller than 13 mm was a risk factor for failure of obtaining an adequate specimen for histological assessment (P = 0.010) Conclusions The novel 25-gauge Franseen needle showed excellent diagnostic yield for solid pancreatic masses. However, its ability to obtain an adequate specimen for histological assessment may still be insufficient, especially when dealing with small lesions.

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“…In previous case reports[ 25 - 28 ], the location of the recurrent tumor appearing in the gastric wall is very close to the previous FNA puncture site, supporting the hypothesis that the tumor may spread along the needle track following EUS-FNA. As for EUS-FNB, previous studies have reported that it has a comparable adverse event rate (varied between 0-7.8%) to EUS-FNA[ 29 - 33 ], and the recurrence due to needle tract seeding after EUS-FNB is also considered a rare event. Recently, Kawabata et al[ 34 ] have reported a case of tumor seeding caused by EUS-FNB.…”

Section: Eus-fna- or Eus-fnb-induced Needle Tract Seedingmentioning

confidence: 99%

Overlooked risk for needle tract seeding following endoscopic ultrasound-guided minimally invasive tissue acquisition

Gao

Shen

et al. 2020

WJG

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Endoscopic ultrasound-guided minimally invasive tissue acquisition can be performed by two approaches as follows: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) and endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB). These have been evolved into leading approaches and widely used for the histological diagnosis of tumors in the gastrointestinal tract and adjacent organs. However, the role of EUS-FNA and EUS-FNB in disease diagnosis and evaluation remains controversial. Although the incidence of surgery-associated complications remains low, the consequences of needle tract seeding can be serious or even life-threatening. Recently, increasing case reports of needle tract seeding are emerging, especially caused by EUS-FNA. This complication needs serious consideration. In the present work, we integrated these case reports and the related literature, and summarized the relevant cases and technical characteristics of needle tract seeding caused by EUS-FNA and EUS-FNB. Collectively, our findings provided valuable insights into the prevention and reduction of such serious complication.

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Prospective Assessment of the Performance of a New Fine Needle Biopsy Device for EUS-Guided Sampling of Solid Lesions

Abstract: The new Franseen tip FNB device provides histologically superior and cytologically comparable specimens to those obtained by FNA, but with fewer passes.

Cited by 54 publications

References 23 publications

Endoscopic Ultrasound Fine-Needle Aspiration versus Fine-Needle Biopsy for Lymph Node Diagnosis: A Large Multicenter Comparative Analysis

Endoscopic Ultrasound Fine-Needle Aspiration versus Fine-Needle Biopsy for Lymph Node Diagnosis: A Large Multicenter Comparative Analysis

Prospective evaluation of 25-gauge Franseen needles for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic masses

Overlooked risk for needle tract seeding following endoscopic ultrasound-guided minimally invasive tissue acquisition

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