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• W2800810065 abstract "EUS-guided tissue acquisition (EUS-TA) plays a fundamental role in the diagnosis of pancreatic masses. The ideal EUS-TA technique and device is that which will maximize diagnostic yield, specimen adequacy, and accuracy while minimizing adverse event rates and costs.1Wani S. Shah R.J. EUS-guided tissue acquisition: do we need to shoot for a “core” to score?.Gastrointest Endosc. 2016; 84: 1047-1049Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar Several factors have an impact on EUS-TA outcomes, including (1) sampling methods and techniques (use of suction, fanning, capillary technique, number of passes, methods of sample expression), (2) availability of rapid onsite evaluation (ROSE), (3) endosonographer and cytopathologist qualifications (training and experience), and (4) type of specimen and needle used.2El Hajj II, Al-Haddad Endoscopic ultrasound-guided tissue acquisition of pancreatic masses.Tech Gastrointest Endosc. 2018; 87: 30-38Crossref Scopus (3) Google Scholar EUS-FNA has been the mainstay for sampling pancreatic masses for more than 2 decades but has several limitations. Well-differentiated adenocarcinomas, lymphomas, and cancers arising in the context of chronic pancreatitis can be difficult to diagnose by FNA cytologic analysis alone. To address such limitations, fine-needle biopsy (FNB) with specialized needles was introduced to provide histologic-quality tissue samples. The first needle introduced (Quick-Core) was associated with technical failures and later gave way to an improved needle with a reverse bevel design from the same manufacturer (ProCore, Cook Medical, Bloomington, Ind). In a recent meta-analysis including 9 studies of 576 patients, no significant difference in diagnostic adequacy (75 % vs 89%), diagnostic accuracy (86 % vs 86%), or rate of histologic core specimen acquisition (78 % vs 77 %) was found between the ProCore and the standard FNA needles, respectively.3Bang J.Y. Hawes R. Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition.Endoscopy. 2016; 48: 339-349PubMed Google Scholar The mean number of passes required for diagnosis, however, was significantly lower when the ProCore needle was used (standardized mean difference, 1.2; P < .001).3Bang J.Y. Hawes R. Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition.Endoscopy. 2016; 48: 339-349PubMed Google Scholar Therefore, FNB has continued to be reserved to niche applications such as suspected autoimmune pancreatitis, lymphoma, and subepithelial lesions and as a salvage technique when FNA sampling fails to provide adequate or conclusive cytologic results.4Iglesias-Garcia J. Poley J.W. Larghi A. et al.Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study.Gastrointest Endosc. 2011; 73: 1189-1196Abstract Full Text Full Text PDF PubMed Scopus (240) Google Scholar In the past 3 years, the EUS-FNB sampling landscape started to shift again with the advent of 2 recently introduced devices of markedly different tip designs. The first carries a Franseen tip design with 3 symmetric cutting surfaces (Acquire, Boston Scientific Corp, Natick, Mass), and the other possesses a fork-tip design with 2 leading sharp tips (SharkCore, Medtronic, Minneapolis, Minn). Although a growing number of studies have described the performance of the Franseen and fork-tip needles (Table 1),5Rodrigues-Pinto E. Jalaj S. Grimm I.S. et al.Impact of EUS-guided fine-needle biopsy sampling with a new core needle on the need for onsite cytopathologic assessment: a preliminary study.Gastrointest Endosc. 2016; 84: 1040-1046Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar, 6Kandel P. Tranesh G. Nassar A. et al.EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study.Gastrointest Endosc. 2016; 84: 1034-1039Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar, 7Abdelfatah MM, Grimm IS, Gangarosa LM, et al. Cohort study comparing the diagnostic yields of 2 different EUS fine-needle biopsy needles. Gastrointest Endosc. Epub 2017 Sep 4.Google Scholar, 8Nayar M.K. Paranandi B. Dawwas M.F. et al.Comparison of the diagnostic performance of 2 core biopsy needles for EUS-guided tissue acquisition from solid pancreatic lesions.Gastrointest Endosc. 2017; 85: 1017-1024Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar, 9Bang J.Y. Hebert-Magee S. Hasan M.K. et al.Endoscopic ultrasonography-guided biopsy using a Franseen needle design: initial assessment.Dig Endosc. 2017; 29: 338-346Crossref PubMed Scopus (91) Google Scholar, 10Jovani M. Abidi W.M. Lee L.S. Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study.Scand J Gastroenterol. 2017; 52: 784-787Crossref PubMed Scopus (26) Google Scholar, 11Al-Haddad M. Patel K. Othman M.O. Prospective assessment of the performance of a new fine needle biopsy device at 2 large referral centers.Gastrointest Endosc. 2017; 85 ([abstract]): AB333Abstract Full Text Full Text PDF Google Scholar, 12Al-Haddad M. Reuss S. Gromski M.A. et al.Prospective assessment of the performance of a new fine needle biopsy device for EUS-guided sampling of solid lesions.Am J Gastroenterol. 2017; 112: S435-S436Google Scholar, 13Bang J.Y. Hebert-Magee S. Navaneethan U. et al.Randomized trial comparing the Franseen and fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions.Gastrointest Endosc. 2018; 87: 1432-1438Abstract Full Text Full Text PDF PubMed Scopus (87) Google Scholar there are no randomized trials directly comparing the tissue yield of the 2 needles.Table 1Results of published studies of new FNB needlesStudyStudy typeType of needle(s)No. of patientsNo. of lesionsType of lesionsROSEAEsOutcomesRodrigues-Pinto et al, 20165Rodrigues-Pinto E. Jalaj S. Grimm I.S. et al.Impact of EUS-guided fine-needle biopsy sampling with a new core needle on the need for onsite cytopathologic assessment: a preliminary study.Gastrointest Endosc. 2016; 84: 1040-1046Abstract Full Text Full Text PDF PubMed Scopus (57) Google ScholarRetrospective cohortFork-tip3342Pancreatic 14 Nonpancreatic 282 (6%)FNB sampling without ROSE performed as well as FNA with ROSE, without loss of diagnostic accuracyKandel et al, 20166Kandel P. Tranesh G. Nassar A. et al.EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study.Gastrointest Endosc. 2016; 84: 1034-1039Abstract Full Text Full Text PDF PubMed Scopus (100) Google ScholarRetrospective case-control (1:3 ratio)Fork-tip156FNB 39 FNA 117100%0Significantly higher histology yield with fewer passes with FNB needle compared with FNA needleAbdelfatah et al, 20177Abdelfatah MM, Grimm IS, Gangarosa LM, et al. Cohort study comparing the diagnostic yields of 2 different EUS fine-needle biopsy needles. Gastrointest Endosc. Epub 2017 Sep 4.Google ScholarRetrospective comparative cohortFork-tip Franseen179194 Fork-tip 97 Franseen 97Neoplasm 131 Benign 7 Nondiagnostic 5412%0Diagnostic yield when used primarily without ROSE high in both groups but significantly higher with fork-tip needleNayar et al, 20178Nayar M.K. Paranandi B. Dawwas M.F. et al.Comparison of the diagnostic performance of 2 core biopsy needles for EUS-guided tissue acquisition from solid pancreatic lesions.Gastrointest Endosc. 2017; 85: 1017-1024Abstract Full Text Full Text PDF PubMed Scopus (48) Google ScholarProspective comparative cohortFork-tip Procore201201 Fork-tip 101 ProCore 100PDAC 77 GIST 1 Other tumors 11 Benign 12N/A0Superior tissue yield and diagnostic performance with fork-tip needleBang et al, 20179Bang J.Y. Hebert-Magee S. Hasan M.K. et al.Endoscopic ultrasonography-guided biopsy using a Franseen needle design: initial assessment.Dig Endosc. 2017; 29: 338-346Crossref PubMed Scopus (91) Google ScholarRetrospectiveFranseen30Franseen alone 24 after failed FNA 6PDAC 12 GIST 5 Other tumors 4 Benign 9100%1 (3%)Franseen needle yields diagnostic material for ROSE and histology in >95% of patientsJovani et al, 201710Jovani M. Abidi W.M. Lee L.S. Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study.Scand J Gastroenterol. 2017; 52: 784-787Crossref PubMed Scopus (26) Google ScholarRetrospective comparative cohort (1:1 ratio)Fork-tip102Fork-tip needle similar to standard FNA needles for number of passes to reach diagnosis, but obtained significantly more histologic specimenAl-Haddad et al, 201711Al-Haddad M. Patel K. Othman M.O. Prospective assessment of the performance of a new fine needle biopsy device at 2 large referral centers.Gastrointest Endosc. 2017; 85 ([abstract]): AB333Abstract Full Text Full Text PDF Google ScholarProspectiveFranseen4345PB 22 Subepithelial 7 Lymph nodes 7 Liver 5 Miscellaneous 5100%0Adequate tissue for cytopathologic and histopathologic assessments including immunostainsAl-Haddad et al, 201712Al-Haddad M. Reuss S. Gromski M.A. et al.Prospective assessment of the performance of a new fine needle biopsy device for EUS-guided sampling of solid lesions.Am J Gastroenterol. 2017; 112: S435-S436Google ScholarProspective case-controlFranseen101FNB 51 FNA 50FNB gp: Pancreatic 23, Nonpancreatic 28 FNA gp: Pancreatic 20, Nonpancreatic 30100%2 (4%)Mean histology scores on cellblock higher in FNB group (P = .046) with overall lower mean number of passes (P ≤ .001); diagnostic yield of FNB 96% vs 88% for FNA groupBang et al, 201813Bang J.Y. Hebert-Magee S. Navaneethan U. et al.Randomized trial comparing the Franseen and fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions.Gastrointest Endosc. 2018; 87: 1432-1438Abstract Full Text Full Text PDF PubMed Scopus (87) Google ScholarRandomizedFork-tip Franseen5050PDAC 44 NET 2, Lymphoma 1, CP 3100%No difference between 2 needles in yielding histologic tissue; diagnostic yield on cell block in >90%AEs, Adverse events; CP, chronic pancreatitis; FNB, fine-needle biopsy; GIST, gastrointestinal tumor; NET, neuroendocrine tumor; PB, pancreaticobiliary; PDAC, pancreatic duct adenocarcinoma; ROSE, rapid onsite evaluation. Open table in a new tab AEs, Adverse events; CP, chronic pancreatitis; FNB, fine-needle biopsy; GIST, gastrointestinal tumor; NET, neuroendocrine tumor; PB, pancreaticobiliary; PDAC, pancreatic duct adenocarcinoma; ROSE, rapid onsite evaluation. In this issue of Gastrointestinal Endoscopy, Bang et al13Bang J.Y. Hebert-Magee S. Navaneethan U. et al.Randomized trial comparing the Franseen and fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions.Gastrointest Endosc. 2018; 87: 1432-1438Abstract Full Text Full Text PDF PubMed Scopus (87) Google Scholar report on the first randomized trial comparing the histologic yield between the 22-gauge Franseen and fork-tip needles in sampling solid pancreatic masses. The study included 50 patients in whom EUS-guided sampling was performed with both needle types, with randomization of the order in which the 2 needles were used. After 2 dedicated passes were performed for cell blocks for histologic analysis with the randomized needle, 2 additional passes were made for cell blocks with the alternative needle. Subsequent passes were devoted to rapid onsite evaluation (ROSE) by the use of both needles alternately until tissue adequate for a diagnosis was accrued. The main outcomes of the study—histologic adequacy and tumor morphology—were assessed with image-analyzing software. The majority of patients in the study cohort had pancreatic tumors (mainly adenocarcinoma), and 3 patients had chronic pancreatitis. The authors reported no difference in tissue quantity or quality accrued by either the 2 needles, as assessed by the total area of tissue obtained, proportions of the areas of tumor to total tissue, and area of desmoplastic fibrosis yielded by the 2 needles. The rates of diagnostic cell block (96% vs 92%, P = .32) and ROSE diagnostic adequacy (94% vs 98%, P = .32) were comparable between the Franseen and fork-tip needles, respectively. No adverse events were encountered in any patient. A few limitations of this study are well outlined and discussed by the authors. The inclusion of pancreatic masses only limits the applicability of the results to other more-challenging lesions like subepithelial masses, where the diagnostic yield of FNA is well known to be significantly lower than in pancreatic masses. One might argue that the excellent performance of FNA in solid pancreatic masses (exceeding 85% diagnostic yield in most published studies) makes a less-compelling case to switch to FNB in such lesions. Additionally, the study design did not allow for a detailed assessment of the operating characteristics of the 2 needles, and it does not include a well-sought comparison with the more widely used reverse bevel needle. We commend the authors on their efforts to meticulously study the sampling capabilities of these 2 novel needles. However, several queries around the methodology of the study arise. It is notable that randomization pertained only to the order and sequence of the needles used, inasmuch as both needles were used in all patients but with variable sequences. Although this is an acceptable methodology, randomization to only 1 device with “salvage crossover design” has been the standard in most EUS-based sampling studies but would have required a larger sample size. In addition, we find it interesting that the samples dedicated to cell blocks were accrued initially in the process, and ROSE samples were obtained later. This sequence could be most helpful to serve the primary outcomes of the study that used cell blocks but could—at least theoretically—hinder onsite review efforts. This is largely due to the diminishing yield of repeated passes well described in the EUS literature and thought to be possibly related to tissue trauma and the introduction of blood. Finally, early data from new FNB devices raised concerns about a small but notable risk of bleeding and postprocedural pain and pancreatitis (Table 1). Despite extensive sampling of lesions used in this study protocol (at least 6 passes/mass), no adverse events were reported in any patient. We believe that the safety profile of such needles is a critical matter, deserving prospective studies to assess. In a recent single-center retrospective study, Abdelfatah et al7Abdelfatah MM, Grimm IS, Gangarosa LM, et al. Cohort study comparing the diagnostic yields of 2 different EUS fine-needle biopsy needles. Gastrointest Endosc. Epub 2017 Sep 4.Google Scholar compared the same 2 FNB devices in the sampling of a variety of solid lesions under EUS guidance. One hundred ninety-four lesions were sampled by the use of one of two 22-gauge Franseen or fork-tip needles. In sharp contrast to the results of the study under discussion, the overall diagnostic yield was significantly lower in the Franseen needle group than in the fork-tip group (63% vs 77%; P = .027) according to Abdelfatah et al.7Abdelfatah MM, Grimm IS, Gangarosa LM, et al. Cohort study comparing the diagnostic yields of 2 different EUS fine-needle biopsy needles. Gastrointest Endosc. Epub 2017 Sep 4.Google Scholar Similarly, subgroup analysis demonstrated a lower yield with the Franseen needle in solid pancreatic masses (64% vs 85%; P = .017). This discrepancy was not observed in the current prospective study, but it highlights the need of further larger randomized trials to address subtle performance differences in novel FNB devices.14Al-Haddad M. Fine-needle biopsy sampling under EUS guidance: is one needle tip really better than the other?.Gastrointest Endosc. 2018; 87: 1163Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar At our center, we have increasingly embraced FNB as a replacement for FNA in solid lesion sampling because we came to realize the benefits of shorter procedure times and fewer number of passes performed in FNB cases (Temnykh LM, unpublished data). We propose an “FNB-exclusive” algorithm to sample all solid lesions under EUS that could result in reduced procedure times (mainly due to fewer passes) and improved efficiency in busy endoscopy units (Fig. 1). We acknowledge, though, the need to study the cost effectiveness of this approach in a prospective fashion, taking into account needle costs and savings resulting from reduced procedure times and the potential elimination of ROSE. This question remains: Is there sufficient literature at this time supporting EUS-FNB to fully replace FNA as the main sampling technique? FNB appears to provide histologically superior tissue samples compared with FNA, putting the utility and cost of ROSE to question. That having been said, many additional questions remain unanswered. What is the ideal FNB sampling technique? How many passes are needed from various lesions if ROSE will no longer be used? Does improved tissue yield justify the higher costs of FNB needles? How about the safety of FNB? Owing to factors inherent to the tip design, an assumption that FNB platforms perform similar to mainstream FNA from a safety standpoint is probably inaccurate and requires close evaluation. In conclusion, a growing body of literature supports that FNB improves the diagnostic yield in EUS-guided sampling of solid lesions and provides a cytologic diagnosis superior to that of FNA. Because many factors affect its outcomes, and as new devices become available, a better understanding of the best practices in FNB sampling becomes essential. Dr Al-Haddad is the recipient of teaching and research support from Boston Scientific. The other author disclosed no financial relationships relevant to this publication. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesionsGastrointestinal EndoscopyVol. 87Issue 6PreviewRecently, a 3-plane symmetric needle with Franseen geometry and a Fork-tip biopsy needle have been developed for histologic tissue procurement. We compared 22-gauge Franseen and 22-gauge Fork-tip needles in patients undergoing EUS-guided sampling of pancreatic masses. Full-Text PDF" @default.
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• W2800810065 title "EUS-FNA giving way to fine-needle biopsy: Is it time to retire your old trusted needles?" @default.
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