"ROSE" Revealing Its True Beauty-Comparing the Efficacy of Rapid On-Site Evaluation (ROSE) in Determining Specimen Adequacy in Fine Needle Aspiration Cytology Relative to Without ROSE: A Single-Center Study.

Fine needle aspiration (FNA) cytology is a basic diagnostic technique usedto investigate superficial and deep swellings. Rapid on-site evaluation (ROSE) using toluidine blue (TB) is easily available, cheap, cost-effective, can be used both for testing adequacy andgiving provisional diagnosis. To evaluate the role of ROSE using toluidine blue staining in arriving ata diagnosis in comparison to routine stains. A total of 1500 cases of FNA of palpableswellings from sites like salivary gland, breast, thyroid, lymph node, and soft tissue lesions [non-image guided] during a 9-month periodwere studied. All the cases were evaluated by ROSE using toluidine blue stain and routine Giemsa/PAP staining. The results were compared in each case. Only 2% cases proved inadequate on TB, Giemsa and PAP combination, commonest site of inadequacy being lymph node. Adequate sample was obtained within two passes in 92.5% cases. The turn-around time (TAT) was 1day in 96.4% of cases. The average time for making a provisional diagnosis on TB was 3minutes. There was 99.2% concordance between TB and final cyto-diagnosis. Validity parameters: sensitivity 98%, specificity 100%, positive predictive value 100%, negative predictive value 99.8%, efficacy 99.2%and false negative 1.94%. ROSE using toluidine blue is a reliable means of demonstrating sample adequacy, for making a provisional diagnosis and guiding collection of diagnostic material for microbiology, immunocytochemistry (ICC), cell block and molecular testing etc. The technique is easy enough for general laboratories to incorporate into their routine practice.ROSE can be called as the"frozen section of cytology".

Rapid on-site evaluation and cell blocks: getting the most from the least invasive method in cytopathology

Rapid On-Site Cytologic Evaluation During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration for Nodal Staging in Patients With Lung Cancer

On‐site cytopathology for endoscopic ultrasound‐guided fine‐needle aspiration of solid pancreatic masses

A “ROSE” in Every “EBUS” Keeps Transbronchial Lung Biopsy Away

To determine: (1) the accuracy of cytology scientists at assessing specimen adequacy by rapid on-site evaluation (ROSE) at fine needle aspiration (FNA) cytology collections; and (2) whether thyroid FNA with ROSE has lower inadequacy rates than non-attended FNAs. The ROSE of adequacy for 3032 specimens from 17 anatomical sites collected over a 20-month period was compared with the final report assessment of adequacy. ROSE was performed by 19 cytology scientists. The report profile for 1545 thyroid nodules with ROSE was compared with that for 1536 consecutive non-ROSE thyroid FNAs reported by the same cytopathologists during the study period. ROSE was adequate in 75% (2276/3032), inadequate in 12% (366/3032) and in 13% (390/3032) no opinion was rendered. Of the 2276 cases assessed as adequate by ROSE, 2268 (99.6%) were finally reported as adequate for assessment; eight specimens had adequacy downgraded on the final report. Fifty eight per cent of cases with a ROSE assessment of inadequate were reported as adequate (212/366), whereas 93% (363/390) with no opinion rendered were reported as adequate. The overall final report adequacy rate for the 3032 specimens was 94% (2843/3032). Confirmation of a ROSE of adequacy at reporting was uniformly high amongst the 19 scientists, ranging from 98% to 100%. The inadequacy rate for thyroid FNAs with ROSE (6%) was significantly (P<0.0001) lower than for non-ROSE thyroid FNAs (17%). A significantly (P=0.02) higher proportion of adequate ROSE thyroid specimens was reported with abnormalities, compared with non-ROSE thyroid collections. Cytology scientists are highly accurate at determining specimen adequacy at ROSE for a wide range of body sites. ROSE of thyroid FNAs can significantly reduce inadequate reports.

Endoscopic ultrasound guided fine needle aspiration (EUS FNA) has been in existence for more than 20 years with the first EUS FNA performed in 1992 1 followed by first EUS FNA diagnosis of pancreatic cancer in 1994 2. Since then, it has proven to be a very safe and reliable procedure. Multiple studies have shown an impeccable safety record. In a recent study of 3090 consecutive EUS FNA patients, the bleeding risk and perforation risk was only 0.1% and 0.01%, respectively 3. A systematic review reported an overall morbidity of 0.98%, pancreatitis of 0.44%, post-procedural pain of 0.34% and mortality of 0.02% in 10 941 patients undergoing EUS FNA 4. It is an indispensable modality in obtaining tissue diagnosis from various solid and hollow viscera as well as lymph nodes. In particular, pancreatic mass lesions are diagnosed with high sensitivity and specificity. Systematic review and meta-analysis have reported a sensitivity of 85.0–86.8% and specificity of 95.8–98.0% 5, 6. The sensitivity and specificity for differentiating malignant from benign lesions was 91.5% and 97.7% 7, respectively. Even for small lesions measuring less than 1 cm, the diagnostic accuracy is 96% 8. Diagnosis of intramural lesions within a hollow viscous was initially more challenging. Williams et al. published an accuracy of 50%, sensitivity of 25% and specificity of 38% in 1999 9. However, subsequent studies have demonstrated higher diagnostic accuracy between 80.0% to 95.6% 10-13. EUS FNA of lymph nodes is frequently successful with adequate specimens obtained in 87% of cases with sensitivity, specificity and diagnostic accuracy between 71–75%, 95–99% and 85–90%, respectively 14, 15. When considering mediastinal lymph node sampling, a meta-analysis of 76 studies showed a sensitivity of 88% and specificity of 96% 16. Despite the high success rate of EUS FNA in securing a diagnosis with a minimal complication rate, there is still potential for refinement influenced by choice of needle, FNA technique augmentation as well as specimen handling to further improve clinical outcomes for patients. There is currently a wide range of needle sizes and types at one's disposal. Needle size options include 19, 22 and 25 gauges, each possessing unique advantages and disadvantages. Needle types include: straight needle for FNA, spring-loaded Trucut and reverse side bevel for FNA/B, and other emerging novel needles (e.g. built in side port, cryotechnology). Larger needles theoretically acquire a larger volume of tissue; however, it does not always equal a higher yield 17 as technical factors may come into play and conversely a smaller needle may be advantageous. In general, the size of needle should be tailored towards what the endosonographer is aiming to achieve (cytology vs histology) and characteristics of the target lesion. Thus, the needle size and type is tailored to the specific lesion targeted and clinical context. The 19 g needle (Fig. 1) is useful in situations where a larger volume of cells or core histology 12, 18-21 is required. For example, the large needle may be used to make a diagnosis of autoimmune pancreatitis 22 or for the diagnosis of lymphoma and certain neuroendocrine tumors, where immunohistochemical staining is needed. Although more tissue can be potentially obtained with the 19 g, this can be hampered by technical failures due to stiffness of the needle and an angulated or torqued scope position resulting in reduced maneuverability compared to the 22 g 23, 24. A modified technique has been described involving removal of the stylet prior to extension of the 19 g needle in the duodenal lumen to improve technical success in the pancreatic head and uncinate areas, which had an overall feasibility of 99% 12. However, the proportion of lesions requiring transduodenal puncture was not entirely clear and 62.5% of cases used a forward viewing echoendoscope, which has a larger working channel and no elevator, and therefore, may not be comparable to the standard linear echoendoscope. Nevertheless, a flexible 19 g nitinol needle (Expect 19 Flex; Boston Scientific, Natick, MA, USA) had been developed and 100% technical success for FNA of lesions around the head and uncinate have been reported 20, 25. When compared to the smallest needle (25 g), a recent multicenter randomized control trial (RCT) published in abstract form reported no significant difference in diagnostic accuracy when targeting large pancreatic lesions. The only significant difference between the 19 g and 25 g was greater bloody contaminant in the 19 g group 26. Currently most operators have the 22 g or 25 g (Fig. 1) as their needle of choice when performing FNA in solid lesions. The advantage of a smaller caliber 25 g needle in general include maneuverability during transduodenal FNA 17 whilst obtaining high quality cellularity with less bloody contamination by utilizing its innate capillary action, which negates the need for syringe suction and may be theoretically safer. There have been multiple studies comparing the 22 g vs 25 g straight needles showing similar overall diagnostic yield 27-30. One study showed a non-statistically significant difference in diagnostic yield of 87.5% (22 g) vs 95.5% (25 g) (P = 0.18) both with similar number of passes and no complications 28. Another study with 842 patients showed the sensitivity and specificity of the 22 g and 25 g was 84% and 100% vs 92% and 97% respectively; however, the P-value was not disclosed. There was a 2% rate of pancreatitis in the 22 g group and none in the 25 g group 29. A recent systematic review and meta-analysis comparing 22 and 25 g, which showed better specimen adequacy in the 25 g with similar diagnostic accuracy and complication rates 30. Lastly a meta-analysis involving 1292 patients showed the 25 g was more sensitive compared to the 22 g (93% vs 85%, P = 0.0003) but comparable specificity (100% vs 97%) 31. On balance, the 25 g FNA needle appears to be the needle of choice for a cytologic diagnosis, particularly for pancreatic solid lesions, unless core histology is required or ancillary testing such as molecular markers or special staining are needed. Initially only the straight tipped needle was available. This was capable of high cytological yield; however, in situations where core histology is required, outcomes were suboptimal 23. This led to alternative needle designs in pursuit of a higher histological yield, especially, as core specimen have become increasingly important in facilitating molecular marker analysis, which allows prognostication as well as individualization of chemotherapy 32. In 2002 the Trucut biopsy (TCB) needle was introduced 33. Unfortunately the Trucut was not widely embraced due to its relatively lower diagnostic yield, high failure rate particularly in the duodenum and slightly higher complication rate 34, 35. However, recent introduction of the core histology needle (CHN) (Cook Medical, Winston-Salem, NC, USA) with an integrated reverse side bevel has generated significant interest and data from studies performed by various groups. Most recently, a multicenter prospective RCT published in abstract form showed FNB having higher diagnostic yield than FNA particularly for non-pancreatic lesions (86% vs 55%, P = 0.02) 36. Katanuma et al. 37 recently published a very nice article which quantified the amount of suction generated through a variety of needle sizes by various suction techniques. This study revealed the suction pressure at the end of a straight or CHN needle to be essentially identical, therefore, the differences in specimen and diagnostic yield, is likely to be related to the structural differences. Currently, the CHN is available in 19 g, 22 g and 25 g. The idea of the CHN was to facilitate a combination of FNA and FNB (FNAB) which would then result in acquisition of a large volume of tissue (Fig. 2) with intact cores for histological analysis. This is advantageous when ancillary testing is required, with previously failed FNA, and when rapid onsite evaluation (ROSE) is unavailable or simply to augment cytology to further increase the overall diagnostic yield 38. Cores are more easily recognized on gross examination of the glass slide compared to clumps of cells, as they have a whitish appearance and maintain some height or bulk on visual inspection (Fig. 2). The recognition of core tissue without microscopy, may lead to higher specimen adequacy and subsequent improved diagnostic yield, especially in the absence of ROSE 39. The use of the 19 g CHN (Fig. 3) was first published in 2011 and has been shown to be technically feasible (98–100%) and produced adequate histological specimen (89.5–94.2%) 40, 41. The 22 g CHN (Fig. 3), when used for intra-abdominal solid mass, has high yield both cytologically and histologically (Fig. 4) with 76% having useful core specimen for pathological diagnosis 42. Performance on pancreatic mass lesions showed a one pass result of 98% feasibility and 88.5% adequate core for histological analysis 43. A randomized trial comparing the 22 CHN vs 22 straight was published in abstract form where 97 patients with mixed lesions were randomized to either needle, with all specimens submitted in cell block only, resulted in a diagnostic yield of 92% (CHN) vs 77% (P = 0.03) 39. In studies comparing number of passes, the 22 g CHN required less in a cohort of mixed pancreatic lesion and lymphadenopathy (1.2 vs 2.5, P ≤ 0.001) 44 and non-pancreatic lesions (2.11 vs 2.94, P = 0.03) 45. However, no difference was seen when restricted to pancreatic lesions 46. One small study compared performance in gastrointestinal subepithelial lesions where the 22 g CHN yielded significantly higher macroscopic (92% vs 30%, P = 0.006) and histological cores (75% vs 20%, P = 0.01) in fewer median number of passes (2 vs 4, P = 0.025) 47. The 25 g CHN has been reported by Iwashita et al. to have a high yield sensitivity of 83%, 91%, and 96% on pass 1, 2, 3, respectively 48. Visible core (Fig. 5) was seen macroscopically in 92% of cases, however histological core only in 32%. All procedures were uncomplicated. An abstract presented at DDW 2014 showed a high cellular and diagnostic yield using the 25 g CHN in absence of ROSE 49. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of EUS-FNAB in which sampling adequacy was assessed by the endosonographer were 93.3%, 100%, 100%, 93.3%, and 96.6% (for cytologic diagnosis) and 92.3%, 100%, 100%, 92.9%, and 96.2% (for histology), respectively. When comparing the 25 g straight to the 25 g CHN, there is little evidence in the literature. One study showed the tissue acquisition rate for histological analysis was 90.6% (CHN) vs 79.6% (straight) (P = 0.025) with definitive histological diagnosis achieved by the 25 g CHN in 81.1% (CHN) vs 69.4% (straight) (P = 0.048) 50. Although the 19 g straight needle was not specifically designed to improve histological yield, its ability to acquire histological material has improved over time. Multiple studies published in 2012 demonstrated high diagnostic yield and accuracy to be in the 90% or higher for pancreatic mass 51, lymphadenopathy 19 or submucosal lesions 12, 20. To date, there has not been a trial comparing the 19 g CHN to the 19 g straight needle. A 22 g side port needle (Olympus, Tokyo, Japan) has been tested in a pilot study 52 and a small study of 30 patients with mixed lesions. The results have been impressive with a diagnostic accuracy of 96.7% after only 1.7 (mean) passes without any complications 53. However, further studies are warranted to confirm this pilot data. An 18 g Cryoprobe (Erbe, Tübingen, Germany) had been trialed in non-survival animal and cadaveric pancreas showing a comparable result to the Trucut and better than 19 g straight needle in terms of tissue specimen quality and size and shorter bleeding time 54. This probe uses carbon dioxide induced cooling to minus 35 degrees, which freezes the tissue without causing apparent histological tissue damage. Specimen extraction is possible due to cryoadhesive effect and can be performed with or without an outer sheath through the scope. There are no safety data regarding this novel modality of tissue acquisition. When histological tissue is required, the needle of choice should be the 19 g CHN, 22 g CHN or 19 g straight needle. The benefit of suction is controversial and an established standard is lacking. Varying degrees of suction can be applied from slow pull of the stylet from the needle, which in turn generates microsuction, to 5 or 10 ml of syringe suction, to continuously high (30 ml) suction facilitated by the Alliance II inflation system (Boston Scientific, Natick, MA, USA) 55 termed EUS-FNTA. By using suction, a higher volume of aspirate can be acquired, which may or may not be useful depending on the situation. According to the Katanuma study 37 maximal suction power (when attached to a suction syringe) of a 19 g needle is approximately two to three times and seven to eight times more than the 22 g and 25 g needle, respectively. This is the likely mechanism for increased specimen yield when using the largest needle primarily for histology. Certainly suction can be attempted in situations where cellularity is inadequate without suction or in fibrotic lesions 56, whereas in more vascular lesions such as lymph nodes, suction may cause more bleeding and therefore negatively affect the specimen quality 57-59. Two RCTs found conflicting results in FNA of pancreatic mass lesions where one found suction resulted in higher diagnostic samples and cellularity; however, specimen bloodiness was increased 60 and the other found no difference in diagnostic yield, cellularity, or specimen bloodiness, irrespective of whether or not suction was used 61. A trial comparing the slow pull with the suction technique showed better sensitivity and less blood contamination when using a 25 g FNA needle but no significant difference when using the bigger 22 g needle for pancreatic mass 62. The Katanuma study 37 revealed that the suction pressure of a 25 g needle without suction vs slow pull was very similar and possibly below the level of tissue pressure, therefore reducing the likelihood of a bloody aspirate. In animal studies, when using the CHN, ironically slow pull acquired larger tissue volume than suction 63. In a study of 50 patients, a very high first pass diagnostic accuracy of 86% was achievable by combining the 25 g CHN with the slow pull technique 48; however, no comparison with other techniques was made. Two studies investigating the high suction FNTA method using a 22 g needle showed a diagnostic accuracy of approximately 77% 55, 59 with one pass. Given suction did not clearly show a benefit, this led investigators to modify the conduit, which transmits the negative pressure within the needle. Given that fluid is less compressible than air, greater negative pressure therefore can be transmitted to the end of the needle. The results of a computer generated model was recently published in abstract form, which showed a 70% theoretical increase in total volume of tissue aspirated with fluid primed needle vs dry suction 64. Clinically, using normal saline primed needle and 10 ml of suction during FNA yielded superior cellularity (1.83 vs 1.33, P = 0.001) and diagnostic rate (85.5% vs 74.4%, P = 0.0001) compared to dry suction technique when using a 22 g needle 65. However, when using heparin instead of normal saline in a group of 60 patients, there was no difference in diagnostic adequacy, number of passes or specimen bloodiness 66. Another interesting study published in abstract form compared three different suction techniques 67, namely, dry, wet and hybrid. Dry suction was described as the conventional method of stylet removal after puncture, application of continuous 10 ml of syringe suction followed by 12 to and fro movements. The wet technique involved priming the needle with normal saline by attaching a 10 ml syringe prefilled with 3 ml of normal saline. FNA was performed with three to and fro movements first then applying 10 ml of suction. The to and fro then suction maneuver was repeated four times to total 12 to and fro movements. The hybrid technique involved the same needle preparation as the wet technique, but with constant 10 ml of suction. The difference in specimen adequacy was 87% (wet), 87% (hybrid) and 67% (dry) and diagnostic yield was 100% (wet), 92% (hybrid) and 90% (dry) which was not statistically significant. This may be due to an under powered study as only a total of 45 FNA passes were performed on 15 solid lesions. The theory of using stylet is to minimize contaminants from entering and obstructing the lumen of the FNA needle, which result from the initial puncture. However, a large retrospective study involving over 3000 patients 68 and a prospective comparison study where the same lesion was sampled with and without stylet showed no difference in diagnostic yield 69. Furthermore, two RCTs also showed no difference in diagnostic yield with or without the use of a stylet 70, 71. However, these studies examined predominantly 22 and 25 g needle, not the 19 g. Therefore, advocacy for stylet usage is most likely dependent on personal anecdotes. The 22 g needle did not confer any advantage over the smaller 25 g when no stylet was used 72. The stylet appears to be the best method of pushing the cells out of the needle, therefore, having the stylet remain in the needle, as with the “slow-pull” technique, reduces the stylet handling, as the stylet never leaves the needle. Diagnosis of typical lesions are usually straightforward, however, this can be augmented with the fanning technique described by Bang et al. 73 in a randomized trial showed almost 30% increase in diagnostic yield in the first pass. This technique makes logical sense in that all areas of the lesion are systematically sampled instead of targeting the same tract repeatedly or randomly. However, in very large lesions often there is central necrosis. Aiming for the periphery in this instance may avoid the necrotic areas hence increasing diagnostic yield 56; however, this principle does not necessarily apply to lymph node FNA 57. Number of passes and specimen interpretation are intimately related. The optimal number of passes varies depending on the target characteristics and the availability of ROSE. For example, a well differentiated adenocarcinoma may be more difficult to delineate at EUS or be called a definite positive at ROSE, therefore resulting in a higher number of passes 70. It has been reported that three passed for malignant lymph nodes or liver lesions have a very high yield 57, 74. However, in absence of ROSE, the optimal number may be increased for lymph nodes and solid lesions to five and five to seven, respectively 74, 75. Submucosal lesions can be equally difficult to diagnose and performing up to five passes is recommended 13 although one study described plateauing yield after four passes 58. Regarding solid pancreatic lesions, four passes with a 25 g needle may be sufficient with or without ROSE as the yield had been shown to be similar 76. Certainly one of the key factors in minimizing unnecessary passes thereby reducing potential complications, improving efficiency and yet maintaining a high diagnostic yield is the availability of ROSE in most cases. Although ROSE can dramatically improve yield while reducing number of passes performed 77-79, the absolute benefit will vary depending on the pre-existing diagnostic yield by the endosonographer without ROSE. These findings have also been supported by a recent systematic review and meta-analysis 80. However, if the cytopathologist is not available, endosonographer initiated ROSE will also significantly improve diagnostic adequacy 81. The impact of specimen extraction or expression from the FNA needle is poorly studied. Typically the stylet is reinserted in order to push out the acquired specimen. Theoretically air or fluid flush is more complete as there is residual space between the stylet and the needle lumen. A prospective comparative trial investigated specimen expression with conventional stylet insertion vs air flush showed specimens are slightly less bloody with air flush without any impact on diagnostic yield 60. Stylet may still be needed if the needle is obstructed by clot; however, if expelled in a timely matter, air flush is usually adequate 69. Blood and clot should be separated from the specimen slide if possible, as this optimizes the cytological interpretation. For histologic core samples, blood usually does not interfere with histologic interpretation; however, a large amount of blood clots may potentially produce problem blocks. Another consideration regarding specimen preparation is how much material should be committed to preparing a cytology slide as opposed to directly placing into a formalin bottle. The advantage of cytology is the potential to provide an immediate preliminary diagnosis; however, there are several disadvantages including longer procedure time, longer time to official diagnosis, utilizing more resources per case and lower quality of histology due to loss of micro cores to the cytology slide 32. One alternative option is to use solutions such as Cytolyt in which the entire specimen is sent to pathology, and both cytology slides and cell block can be prepared from the sample. A DDW abstract comparing yield between Cytolyt and formalin did not a significant difference if adequate cytology is not available, then one all material into cell block directly without any The use of stylet may be however, the technique when using the 25 g needle appears to be advantageous. suction is an interesting and further of the fanning technique and of necrotic will increase diagnostic ROSE by cytopathologist or endosonographer will improve yield therefore reducing the number of passes required. One should more tissue to cell block if histological diagnosis is a cytologic diagnosis is by ROSE, to the larger histology needles with of the entire specimen for histology. Given the ability to core tissue by EUS the potential for liver biopsy has been studies used the 19 g with success adequate specimen quality been as complete and of specimen specimen from were frequently inadequate only having a patients in their This is particularly as patients are to be more difficult to biopsy as the specimen is to and shorter specimen yield In the first case of autoimmune diagnosed on liver biopsy with a 19 g CHN was published and around that time, et al. published their with a 19 g straight needle where 22 patients were by needle passes a median and of and and a very high diagnostic yield of without any complications or significant years et al. also used a 19 straight needle in 10 patients had liver with two to be The was and was after three passes without complications or significant accuracy was 100% and this only an of to the EUS procedure. data were published in abstract form showing results in over patients using the 19 g straight needle with median and of 17 and when both and were However, characteristics and FNA technique was not on initial pilot studies, EUS guided liver biopsy appears to be safe and well by patients. However, further studies with on patients are needed. There are several factors that can affect the performance of EUS One is the choice of needle and using the available evidence as a the the (Fig. as a to the most needle. factors including fanning technique, slow pull when using the 25 g needle, no stylet or suction for the 22 g and using the core histology needle when ancillary testing is required are also of needle designs and technique, this will no lead to higher specimen yield as well as the of EUS guided FNA or is a to technique during ultrasound guided fine needle aspiration (EUS pull Endoscopic ultrasound guided liver biopsy specimen The is not for the or of any by the than should be to the for the

Studies on the impact of rapid on-site evaluation (ROSE) during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of lymph nodes are retrospective and have shown conflicting results. We aimed to compare the diagnostic yield of EUS-FNA of lymph nodes with ROSE (ROSE+) and without ROSE (ROSE-). This was a multicenter, randomized controlled trial. Consecutive patients who were scheduled to undergo EUS-FNA of mediastinal or abdominal lymph nodes were randomized to ROSE+ or ROSE-. In the ROSE+ group, the number of passes was dictated by the on-site cytotechnician. In the ROSE- group, five passes were performed without interference from the cytotechnician. All samples were reviewed by a single-expert cytopathologist, blinded to group allocation. Primary endpoint was diagnostic yield with and without ROSE. After inclusion of 90 patients, interim analysis showed futility of study continuation since diagnostic yield of ROSE+ and ROSE- were comparable. A total of 91 patients were randomized to ROSE+ (N = 45) or ROSE- (N = 46). Diagnostic yield of ROSE+ and ROSE- and diagnostic accuracy were comparable: 93.3% vs. 95.7% (P = 0.68) and 97.6% vs. 93.2% (P = 0.62), respectively. Two major complications (one per group) occurred (p = 0.99). ROSE- patients more often reported self-limiting post-procedural pain (p < 0.001). Median procedure time for ROSE+ (20 min) and ROSE- (23 min) was comparable (P = 0.06). Median time to review slides in the ROSE- group (12:47 min) was longer than with ROSE+ (7:52 min) (P < 0.001). Mean costs of ROSE- and ROSE+ were comparable: €938.29 (±172.70) vs. €945.98 (±223.38) (P = 0.91), respectively. Diagnostic yield and accuracy of EUS-FNA of mediastinal and abdominal lymph nodes with and without ROSE are comparable. Time needed to review slides was shorter and post-procedural pain was less often reported in the ROSE+ group. Based on the primary outcome, the implementation of ROSE during EUS-FNA of mediastinal and abdominal lymph nodes cannot be advised. (Dutch Trial Register: NTR4876).

Introduction: Thyroid nodules are very common. Many are detected incidentally due to increased head and neck imaging. The majority are benign; however, malignancy can’t be excluded in many cases and tissue sampling is needed. Ultrasound guided fine needle aspiration is an easy and effective way to sample g thyroid nodules. Inadequate sampling was reported in 10-40% of the cases. Rapid On-site Evaluation (ROSE) was proposed to assess obtained sample for adequacy. The aim of this study is to identify the benefit of applying ROSE with US-FNA of thyroid nodules within our institution. Materials and methods: Patients who underwent FNA for thyroid nodules with ROSE availability documented in their procedure note between January 2017 to December 2018 were retrospectively included. All procedures were done by experienced radiologists. Aspirated material was Diff Quik stained for immediate evaluation. The final cytological diagnosis and specimen adequacy was based on The Bethesda system for reporting thyroid cytopathology. Specimen adequacy was compared between ROSE and non-ROSE groups. Results: 442 thyroid nodules were biopsied. ROSE was available for 65 nodules. Non-diagnostic rate with ROSE was 10.8% compared to 13.8% without ROSE with the difference being statistically insignificant. ROSE availability improved sample adequacy of nodules less than 3 cm with statistically significant difference of 100.0% with ROSE vs. 87% without ROSE. Conclusion: The current study does not justify the routine use of ROSE. However, ROSE availability is beneficial with smaller sized thyroid nodules and less experienced radiologists performing the procedure. Doi: 10.28991/SciMedJ-2021-0301-1 Full Text: PDF

Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) with rapid on-site evaluation (ROSE) has been reported to provide a more accurate diagnosis than EUS-FNA without such evaluation. However, even endosonographers can evaluate ROSE regarding sample adequacy. The aim of this study was to evaluate the diagnostic accuracy of EUS-FNA with ROSE by endosonographers compared to ROSE by cytopathologists in patients with solid pancreatic masses. Between September 2001 and October 2005, of the 73 EUS-FNA procedures with the final diagnoses, 38 procedures after the introduction of ROSE by endosonographers (September 2001-September 2003, period 1), and 35 procedures after the introduction of ROSE by cytopathologists (October 2003-October 2005, period 2) were included. The specimens were stained with Diff-Quik stain and assessed. When the on-site assessors (endosonographers or cytopathologists) indicated that the amounts of cell samples were adequate, the procedure was stopped. Results are presented with 95% confidence limits. The average numbers of needle passes were 4.0 +/- 1.6 and 3.4 +/- 1.5 in periods 1 and 2, respectively (P = 0.06). The specimen collection rates were 97.4 and 97.1% in periods 1 and 2, respectively (P = 0.51). Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for malignancy and benign were 92.9, 100, 100, 83.3, and 94.7%, respectively, in period 1, and 93.1, 100, 100, 75.0, and 94.3%, respectively, in period 2 (P = 0.97, P = 1.0, P = 1.0, P = 0.65, P = 0.93, respectively). No complications were seen. For accurate diagnosis, ROSE should be performed during EUS-FNA by the endosonographer, if no cytopathologist is available.

The role of rapid on-site evaluation (ROSE) for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic lesions is debatable. In this study, we aimed to compare the diagnostic yield of ROSE vs. non-ROSE in solid pancreatic lesions. This retrospective single-center study included patients undergoing EUS-FNA of solid pancreatic lesions from 2019-2021. Patients with cystic lesions, those undergoing fine-needle core biopsy, those undergoing repeat procedures, and patients with non-diagnostic smears with less than 6-month follow up were excluded. The diagnostic yield, need for repeat procedures and number of passes required with and without ROSE were analyzed in these patients. Of the 111 patients included, 56 underwent ROSE. The majority of lesions were malignant in both groups (79.6% ROSE vs. 75% non-ROSE). The diagnostic yield was 96.4% in the ROSE group and 94.5% in the non-ROSE group. Repeat samples were needed in 1 ROSE and 2 non-ROSE patients. The median number of passes made was significantly fewer in the ROSE group (3.5, interquartile range - 3,4) compared with the non-ROSE group (4, interquartile range - 3,5) P=0.01. However, the frequency of procedure-related complications was similar in both groups. The utilization of ROSE during EUS-FNA of solid pancreatic lesions does not affect the diagnostic yield or the need for repeat samples, but reduces the number of passes needed for acquiring samples.

Objective:To prospectively investigate the value of rapid on-site evaluation (ROSE) in transthoracic fine needle aspiration cytology (FNAC) of patients with pulmonary nodules. Computed tomography (CT)-guided FNA is commonly employed for the diagnosis of lung lesions and the most common reason for not being able to provide a diagnosis in FNA is inadequacy of samples.Materials and Methods:This was a prospective study conducted in the departments of pathology and radiology of our cancer centre. This study had approval from the institutional review board and ethical committee of our institute. Fifty consecutive cases undergoing CT-guided transthoracic FNAC in our centre were included in the study. The smear submitted for ROSE was stained using toluidine blue stain. The specimen adequacy and diagnosis in ROSE was compared with that of the final cytology report, and the concordance regarding adequacy and diagnosis were noted.Results:Smears were adequate in 34 cases (68%) and inadequate in 16 cases (32%) Out of the 16 inadequate cases, 5 (31%) were converted to adequate due to the application of ROSE, thus increasing the adequate number of cases to 39 (78%). A diagnosis of malignancy was made in all 39 adequate cases. Sensitivity of ROSE in determining adequacy was 92% and specificity was 100%. The most common malignancy was adenocarcinoma in 26 cases. Pnemothorax occurred in 2 cases. No significant complications occurred in other cases.Conclusion:CT-guided FNA with ROSE is a safe and useful tool in the diagnostic work-up of lung cancer patients. A multidisciplinary approach along with onsite evaluation of adequacy will increase the diagnostic utility of cytology in lung lesions.

Introduction: Milan System for Reporting Salivary Gland Cytopathology (MSRGC) was introduced in the year 2015 to facilitate a standardised reporting format and to improve the overall effectiveness of fine-needle aspiration cytology (FNAC) in the preoperative evaluation of salivary gland lesions. Risk of malignancy (ROM) provided in each category guides the physician for appropriate clinical management. This study was performed prospectively for one year to evaluate the diagnostic utility and validate MSRSGC. Materials and Methods: The study included lesions in the salivary gland area, including intraparotid lymph node. Cytology material from both direct FNAC, which had rapid onsite evaluation (ROSE) for adequacy and ultrasonography-guided procedures, was included for analysis. Relevant clinical information and imaging findings were obtained. Slides were reviewed, and one of the six categories was applied using the Milan system. ROM and risk of neoplasm (RON) were calculated for each category. Results: The study included 62 cases of salivary gland FNAC of which 35.5% of the cases had surgical resection specimens. Category IVA formed the major group, and only 1.6% was given category III. The ROM and RON were calculated for each category and were statistically significant and compared with other studies. Conclusion: MSRSGC is the recent classification system, and it suggests less than 10% of cases under category III to avoid it’s over utilisation. MSRSGC is a reliable classification in our population, and it was best with category IVA lesions in our study.

The utility of rapid on-site evaluation during endobronchial ultrasound with a guide sheath for peripheral pulmonary lesions is unclear. The aim of this study was to evaluate the role of rapid on-site evaluation during endobronchial ultrasound with a guide sheath for peripheral pulmonary lesions. Consecutive patients who underwent endobronchial ultrasound with a guide sheath for the diagnosis of peripheral pulmonary lesions at our hospital between September 2012 and July 2014 were included in this retrospective study. Cytology slides were air-dried, and modified Giemsa (Diff-Quik) staining was used for rapid on-site evaluation. Additional smears were prepared for Papanicolaou staining and tissue samples were placed in formalin for histologic evaluation. The results of rapid on-site evaluation were compared with the final diagnoses of endobronchial ultrasound with a guide sheath. A total of 718 cases were included in the study population. The sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of rapid on-site evaluation during endobronchial ultrasound with a guide sheath for peripheral pulmonary lesions was 88.6%, 65.9%, 81.2%, 77.7% and 80.1%, respectively. There were no procedure-related deaths. Rapid on-site evaluation during endobronchial ultrasound with a guide sheath had high sensitivity for peripheral pulmonary lesions. When carrying out rapid on-site evaluation of transbronchial biopsy samples from peripheral pulmonary lesions, careful interpretation and clinical correlation are necessary.

Introduction: Fine-needle aspiration cytology (FNAC) is an established first-line technique for the evaluation of lymphadenopathy and, with the help of ancillary testing, can in many instances obviate the need for an open biopsy. The Sydney system was recently proposed to provide consensus guidelines for the performance, classification, and reporting of lymph node FNAC. The present study was undertaken to evaluate its utility and study the impact of rapid on-site evaluation (ROSE). Material and Methods: A retrospective analysis in which 1,500 lymph node FNACs was reviewed and assigned a diagnostic category from the Sydney system. Cyto-histopathological correlation and adequacy parameters were evaluated. Observation and Results: The cervical group of lymph nodes was the commonest group aspirated (89.7%). A total of 1,205/1,500 (80.3%) cases were category II (benign), and necrotizing granulomatous lymphadenitis was the most common pathology. The 750 cases with ROSE were subclassified as follows: 15 category I (inadequate), 629 category II (benign), 2 category III (atypia of undetermined significance), 9 category IV (suspicious for malignancy), and 95 category V (malignant). Among 750 cases without ROSE, 75 cases were in category I, 576 in category II, 3 in category III, 6 in category IV, and 90 in category V. Category I was thus significantly lower in the ROSE group compared to the non-ROSE group. Overall, the risk of malignancy was L1-0%, L2-0.20%, L3-100%, L4-92.3%, and L5-100%. Accuracy parameters revealed a sensitivity of 97.7%, specificity of 100%, PPV of 100%, NPV of 99.10%, and diagnostic accuracy of 99.54%. Discussion and Conclusion: FNAC can be used as the 1st line of treatment for lymph node pathology. ROSE can be used as an add-on to FNAC for reducing unsatisfactory rates and help triage material for ancillary testing whenever possible. The Sydney system should be implemented for achieving uniformity and reproducibility.