Introduction

Biopsy samples obtained with fine-needle biopsy (FNB-EUS) using Franseen needles by EUS with endoscopist evaluation (Macroscopic OnSite Evaluation: MOSE) improves the diagnostic accuracy of pancreatic solid lesions. The achievement of macroscopic visible core (MVC) >4mm has a high diagnostic accuracy with MOSE.

Aims & Methods

Aim: To compare diagnostic accuracy of Rapid On-Site Evaluation (ROSE) and MOSE by endoscopist in pancreatic solid lesions.
Methods: Prospective bicentric study, consecutive recruitment of patients with pancreatic solid lesions in 2 general hospitals (MOSE was performed in hospital A and ROSE in hospital B). Franseen needles were used (Adquire, Boston Scientific). We evaluated: 1) diagnostic achievement and accuracy (including sensitivity, specificity, positive predictive value and negative predictive value) in solid pancreatic lesions; 2) MVC >4mm acquisition; and 3) number of needle passes needed with MOSE vs ROSE.

Results

A total of 132 patients were included (33 women, 68 men, median age 68,2±1,025). MOSE was performed in 90 (68.2%) and ROSE in 42 (31.8%); in 110 (83.3%) malign and 22 (16.7%) benign pancreatic solid lesions. Correct diagnosis by EUS-FNB was achieved in 89.4% patients (with MOSE 88.8%; and ROSE 92.9%; p=0.54). Sensitivity was 100%, specificity 89%, PPV 81.3% and NPV 100% (with MOSE: sensitivity 100%, specificity 87.5%, PPV 88.8% and NPV 100%; with ROSE: sensitivity 100%, specificity 92.1%, PPV 92.6% and NPV 100%). MVC >4mm was obtained in 72.7% (71.1% in MOSE, 76.2% in ROSE, p=0.67). There were no statistica ly significant differences in diagnosis achievement between MVC >4mm and <4mm (88.6% in MOSE and 90.6% in ROSE, p=0.74). No differences in number of passes necessary to achieve diagnosis was found between MOSE and ROSE.

Conclusion

Evaluation of biopsy samples of pancreatic solid lesions obtained by FNB-EUS with Franseen needles by endoscopist (MOSE) has a diagnostic accuracy similar to ROSE, making unnecessary the presence of a pathologist in the endoscopy suite.

Introduction

Endoscopic ultrasound (EUS) tissue acquisition requires rapid on-site evaluation (ROSE) to improve diagnostic yield with less needle passes; however, ROSE requires the presence of a cytopathologist and additional cost and time for slide staining and interpretation. Macroscopic on-site evaluation (MOSE) is the direct assessment of the tissue sample provided by EUS-guided fine needle biopsy (EUS-FNB) macroscopically, to detect whether it is sufficient or not.

Aims & Methods

Aim of this study was to evaluate the efficacy of MOSE in terms of tissue acquisition and diagnostic accuracy for abdominal solid lesions
This is a prospective and comparative study including 148 consecutive patients performing EUS-FNB for pancreatic and extrapancreatic solid lesions, randomized by alternate allocation to macroscopic on-site evaluation (MOSE) (74 patients) or to a conventional technique (74 patients), with two passes each. MOSE samples were differentiated into score 0: no visible material, score 1: only necrotic or haematic material, score 2: white core tissue ≤ 2 mm, or score 3: white core tissue > 2 mm. The conventional technique consisted in pushing all the needle content into a test tube for evaluation by the pathologist. In both groups, a 22 Gauge Franseen-tip needle biopsy was used.

Results

The overall diagnostic adequacy was 92.5% (137/148) and accuracy was 86.4% (128/148). The diagnostic accuracy was similar in the two groups: MOSE 87.8% (65/74 lesions), vs. conventional 81.0%, 60/74 lesions, p = 0.34). Regarding diagnostic adequacy, the MOSE technique was 95.9% (71/74 passes) compared to 91.8% (136/148 passes) with the conventional technique, p = 0.04. The accuracy increased according to the MOSE score evaluation: it was 49.3%, 68.9% and 81.3% in patients with score 1, score 2, and score 3, respectively. There was no statistically significant difference between the two groups with conclusive and inconclusive cytopathological results regarding size of the needle, number of needle passes, type of the needle and the specimen acquisition method.

Conclusion

The MOSE score showed a comparable diagnostic accuracy to the conventional technique. However, MOSE allows endoscopists to perform an inspective evaluation of the material, tends to perform better than the conventional technique in terms of diagnostic adequacy, and may potentially reduce the number of passes.

Introduction

Endoscopic ultrasound-guided tissue acquisition, including both fine needle aspiration (EUS-FNA) and fine needle biopsy (EUS-FNB), has been widely performed to obtain samples from pancreatic and non-pancreatic lesions.^{1, 2} The impact of the diagnostic yield between FNA and FNB remains unclear.

Aims & Methods

We conducted this study to compare the diagnostic performance and accuracy of the 22-gauge FNA needles with the 22-gauge FNB needles in sampling solid pancreatic and non-pancreatic lesions. This is a prospective multicenter study conducted on 465 cases presented with solid pancreatic or non-pancreatic lesions.

Results

Patients were 275 male and 190 females with a mean age of 59 years. Three hundred twenty-seven patients had solid pancreatic lesions, while 138 had non-pancreatic lesions; 245 cases underwent EUS-FNA, and the remaining 211 cases underwent EUS-FNB. The presence of intact tissue core and sample adequacy were significantly higher in the FNB cases in solid pancreatic and non-pancreatic lesions. Blood contamination was significantly more in cell blocks and smears of EUS-FNA compared to that of EUS-FNB in solid pancreatic and non-pancreatic lesions. Based on histologic assessment of cell block only, EUS-FNB had more diagnostic accuracy (99%) than FNA (61%) (P-value<0.005). However, cytological diagnosis by smears only showed no significant difference. The combined cytological and histological evaluation had 100% sensitivity, specificity, and accuracy.

Conclusion

EUS-FNA and EUS-FNB have comparable accuracy in diagnosing solid pancreatic and non-pancreatic lesions without ROSE. EUS-FNB is superior to EUS-FNA in acquiring intact tissue core and adequate samples with little blood contamination. Based on histological assessment (cell block/tissue core) only, EUS-FNA has less accuracy than EUS-FNB in diagnosing solid pancreatic lesions.

References

1. Wani S, Muthusamy VR, McGrath CM, et al. AGA white paper: opti- mizing endoscopic ultrasound-guided tissue acquisition and future di- rections. Clin Gastroenterol Hepatol 2018; 16: 318-27.

1. Wong T, Pattarapuntakul T, Netinatsunton N, et al. Diagnostic performance of endoscopic ultrasound-guided tissue acquisition by EUS-FNA versus EUS-FNB for solid pancreatic mass without ROSE: a retrospective study. World J Surg Oncol. 2022; 20(1): 215. doi:10.1186/s12957-022-02682-3.

Introduction

The prediction of positive results of endoscopic ultrasonography guided tissue acquisition(EUS TA), including EUS fine needle aspiration(EUS FNA) and EUS fine needle biopsy(EUS FNB), has changed from rapid on-site evaluation(ROSE) to macroscopic on-site evaluation (MOSE). The average predictive positive rate is about eighties percent under MOSE. The intraoperative frozen section evaluation has been widely used by the surgeons. We conducted the study to evaluate if there is any benefit of intraoperative frozen section evaluation for increasing the predictive diagnostic yield of EUS FNB.

Aims & Methods

Aims: We compared the yield rate of EUS FNB for pancreatic solid lesions between MOSE and intraoperative frozen section evaluation and MOSE only.
Methods: The study was conducted at a single tertiary referral center from Aug. 2021 to Mar. 2023.
The patients who were indicated for EUS FNB were enrolled into the study.
During EUS FNB we sent the specimens from the first two passes for the frozen section after we considered adequate macroscopic visible tissue core. Later we would obtain other specimens from later passes for the permanent section (MOSE + Frozen group (MF group)). As for the control group we sent the specimens for the permanent section only (MOSE only group (M group)).
We compared the histological results of frozen and permanent sections and divided them into three subgroups as the frozen section being equal, inferior and superior to the permanent one.
The p-value <0.05 was defined as statistically significant.

Results

Total one hundred ninety four patients were enrolled into the study and ninety seven patients were divided into each group equally. Demographic characters were as the followings with MOSE with frozen group versus MOSE only one:
age 62+-14 vs 63+-12 years old
gender male to female 1.6: 1 vs 1.6 : 1
diagnosis of pancreatic solid lesion adenocarcinoma : neuroendocrine tumor : chronic pancreatitis 71:5:2 vs 41:5:12
average size of lesion 37.2+-16 vs 34.3+-13 mm
location of lesion uncinate process: head: neck: body: tail 4:32:5:20:11 vs 5:22:0:16:13
the most common location of lesion was head of pancreas on both groups
As for the results of EUS FNB, the pass for permanent section was 5.5 versus 5.8 (MF group vs M group, p=0.018 ) and the transgastric puncture route was 51 versus 53 patients and transduodenal route was 46 vs 44 patients (MF group vs M group). About the yield rate the MF group was 92.8% and the M group was 79.4% (p=0.006).
When comparing the histological results of frozen and permanent sections the frozen section was equal, inferior and superior to the permanent one as 63 (65%), 33 (34%) and 1 (1%) patient(s)(Table).
Table

Conclusion

When performing EUS FNB for pancreatic solid lesions, it seems to increase the predictive yield rate if we combine MOSE and intraoperative frozen section evaluation. There are some pitfalls about combined MOSE and intraoperative frozen section evaluation, such as prolonged procedure time and increased medical expenses due to frozen section evaluation.

References

1. Iwashita T, Yasuda I, Mukai T, et al. Macroscopic on-site quality evaluation of biopsy specimens to improve the diagnostic accuracy during EUS-guided FNA using a 19-gauge needle for solid lesions: a single-center prospective pilot study (MOSE study). Gastrointest Endosc 2015;81:177-85.

Introduction

Endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) has been widely used for the diagnosis of solid pancreatic lesion. Studies have shown that the wet suction technique in EUS-FNA generates better histologic diagnostic accuracy and specimen quality than the dry suction technique. However, conclusions of wet suction on the diagnostic accuracy of EUS-FNB are still controversial. Besides, the optimal number of passes for EUS-FNB has not been determined. We aimed to design a multicenter randomized trial to compare the diagnostic accuracy of dry suction versus wet suction technique in solid pancreatic lesions using 22G Franseen needles and determine the optimal number of passes required for EUS-FNB without onsite cytopathologist.

Aims & Methods

This is a multi-center, open-label, randomized controlled and non-inferiority trial with two parallel groups. The patients with solid pancreatic lesion will undergo EUS-FNB using 22G Franseen needle in 4 tertiary hospitals in China and will be randomly assigned to the dry suction group and wet suction group in a ratio of 1:1. The primary endpoint of this study is to compare the diagnostic accuracy of EUS-FNB for solid pancreatic lesions using the dry or wet suction technique. Secondary endpoints include the optimal number of needle passes, sensitivity, specificity, specimen quality, time of the procedure, and rates of complications.

Results

Of the 195 patients undergoing EUS-FNB enrolled in the final analysis, 96 were randomized to the dry suction group and 99 to the wet suction group. The diagnostic accuracy was 98.95% and 98.98% in the dry and wet groups, respectively, with a 0.05% difference in accuracy between the study groups (two-sided 90% CI, -4.88% to 4.82%, P=0.989). Diagnostic accuracy was shown to be non-inferior because the lower bound of the 90% confidence interval falls to the right of the non-inferiority margin. Compared to the wet group, no significant differences were seen in the sensitivity (98.80 % vs 98.77 %, P = 1) and specificity (100 % vs 100 %, P = 1) in the dry suction group. The overall adverse event rate was 0.52 %, with 0 and 1.02 % in the dry and wet groups, respectively (P = 1). In terms of specimen quality, no significant differences were also seen in the two groups in sample adequacy (100 % vs 98.3 %, P = 0.492) and level of blood contamination (P = 0.319). In terms of puncture time in the dry group compared to the wet group, there was no statistically significant (18.82±8.21 min vs. 18.92±8.99 min, P=0.952), but the wet suction required more time to prepare the saline and the needle. No significant improvement in diagnostic accuracy was seen with the 2nd needle compared to the 1st needle of EUS-FNB (97.41% vs 95.34%，P=0.276), and no significant improvement in diagnostic accuracy was seen with the 3rd shot compared to the 2nd shot of EUS-FNB (98.96% vs 97.41%，P=0.446).

Conclusion

The dry suction technique is non-inferior to the wet suction technique, while saving steps and time. In the absence of rapid on-site evaluation (ROSE), only 1 pass was required to reach the diagnositic accuracy≥ 95% using EUS-FNB with Franseen needle.

Disclosure

The authors disclose no conflicts.

Introduction

Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) is widely recognized as the preferred diagnostic method for pancreatic lesions, achieving diagnostic accuracy rates between 78% and 95%. Rapid on-site evaluation (ROSE) improves adequacy rates but remains unavailable in many centers. In this context, we evaluated a simplified method, Visual On-Site Evaluation (VOSE), based on macroscopic evaluation of the biopsy sample, to predict histo-cytological adequacy without needing ROSE.
Primary aim: assess the accuracy of VOSE in predicting sample adequacy.
Secondary aims: evaluate the diagnostic yield of FNB and the potential reduction in unnecessary needle passes.

Aims & Methods

This prospective single-center study enrolled patients undergoing EUS-FNB for pancreatic lesions between January 2020 and February 2024.
VOSE parameters included the presence of a macroscopic visible core (MVC), number of specimens, and specimen length. Associations between VOSE findings and final histo-cytological adequacy were analyzed using Fisher’s exact test and Student’s t-test. A p-value < 0.05 was considered statistically significant. Study conducted at a university hospital center.

Results

Fifty-nine patients (57.6% male; mean age 67.9 ± 9.8 years) were included, contributing to a total of 59 pancreatic lesions. Across 218 passes performed, the overall sample adequacy rate was 91.5%.
Adequacy was significantly higher when using 22-G needles compared to 25-G needles (95.7% vs. 86.2%, p = 0.018). VOSE criteria (presence of MVC, multiple fragments, and long specimen) demonstrated a sensitivity of 52.3%, a specificity of 61.1%, and a positive predictive value (PPV) of 93.1% for predicting sample adequacy. Applying VOSE led to a 45% reduction in unnecessary additional passes.

Conclusion

EUS-FNB provides excellent diagnostic adequacy for pancreatic lesions, particularly with 22-G needles. The use of VOSE, a simple and reproducible macroscopic evaluation method, can reliably predict histo-cytological adequacy and substantially reduce the number of passes, offering a practical alternative in centers without ROSE availability.

References

1. El Chafic AH, Loren DE, Siddiqui AA. EUS-guided fine-needle biopsy of pancreatic masses: new tools, new techniques. Endosc Ultrasound. 2023;12(1):3-10.
2. Crinò SF, Larghi A, Bernardoni L, et al. EUS-guided fine-needle biopsy with or without ROSE for pancreatic masses: A multicenter randomized trial. Gastrointest Endosc. 2023;98(2):225-234.e3.
3. Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. EUS-guided fine-needle biopsy of pancreatic masses: a meta-analysis comparing FNA and FNB. Gastrointest Endosc. 2022;95(5):893-905.e2.

Introduction

Endoscopic ultrasound-guided fine needles biopsy (EUS-FNB) is nowadays considered mandatory for the assessment of solid pancreatic lesions (SPLs) in the neoadjuvant era. Even if most recent guidelines suggest that not less than 3 passes are sufficient to obtain adequate histological characterization, the right number of needle passes with the newest generation of FNB needles remains a topic of debate. In our study we aim to evaluate if less than 3 passes are enough to ensure high rates of confirmed histological diagnosis with the newest generation of FNB cutting needles.

Aims & Methods

Consecutive patients with SPLs requiring tissue sampling through EUS-FNB were enrolled in our study between October 2022 and March 2023. Tissue sampling was performed by the same expert endoscopist through a new 22G needle with asymmetric three-prong tip with the slow-pull technique and fanning when possible. The number of needle passes was determined by the macroscopic onsite evaluation (MOSE), and samples, coming from different passes, were divided into different test tubes. Our endpoints were diagnostic accuracy, positive core procurement yield and sample quality considering each test tube separetely.

Results

53 lesions (of which 75% pancreatic ductal adenocarcinoma) were sampled with an average size of 31 mm (SD=12mm). Sampling was performed with 2 or 3 passes, according to MOSE. Regarding the first needle pass, diagnostic accuracy was 97% (51 confirmed histological diagnosis) which reached 98% considering the second needle pass. Sample adequacy reached approximately 99%. Positive core procurement and tissue quality were >95% in all test tubes. No major adverse events were detected.

Conclusion

In patients with SPLs, the newest generation of histology needles for EUS-FNB could ensure a high diagnostic accuracy with only one needle pass, becoming extremely relevant in terms of time-saving, cost-effectiveness and safety, especially in high volume centers. Due to the limited number of patients additional data are needed.