Dataset Information

Comparison of Franseen and fork-tip needles for EUS-guided fine-needle biopsy of solid mass lesions: A systematic review and meta-analysis.

ABSTRACT: Franseen-tip and Fork-tip needles have been widely used in EUS guided fine-needle biopsy (FNB) of solid organs. There is conflicting data on the performance of these needles and unanswered questions on the ideal number of needle-passes and the requirement of an onsite cytopathologist (ROSE). We conducted a comprehensive search of multiple electronic databases and conference proceedings including PubMed, EMBASE, and Web of Science databases (from inception through July 2018) to identify studies that reported on the use of Forktip and Franseen-tip needles in EUS-FNB of solid organs. The primary outcome was to estimate and compare the pooled rates of diagnostic-yield. A subgroup analysis compared the outcomes based on the number of needle-passes and the availability of ROSE. A total of 23 study-arms were available for analysis. The pooled rate of diagnostic yield with Fork-tip needle was 92.8% (95% CI 85.3 - 96.6, I2 = 73.1) and the pooled rate of diagnostic yield with Franseen-tip needle was 92.7% (95% CI 86.4 - 96.2, I2 = 88.4).

SUBMITTER: Mohan BP

PROVIDER: S-EPMC6927147 | biostudies-literature | 2019 Nov-Dec

REPOSITORIES: biostudies-literature

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Comparison of Franseen and fork-tip needles for EUS-guided fine-needle biopsy of solid mass lesions: A systematic review and meta-analysis.

Mohan Babu P BP Shakhatreh Mohammed M Garg Rajat R Asokkumar Ravishankar R Jayaraj Mahendran M Ponnada Suresh S Navaneethan Udayakumar U Adler Douglas G DG

Endoscopic ultrasound 20191101 6

Franseen-tip and Fork-tip needles have been widely used in EUS guided fine-needle biopsy (FNB) of solid organs. There is conflicting data on the performance of these needles and unanswered questions on the ideal number of needle-passes and the requirement of an onsite cytopathologist (ROSE). We conducted a comprehensive search of multiple electronic databases and conference proceedings including PubMed, EMBASE, and Web of Science databases (from inception through July 2018) to identify studies t ...[more]

PMID: 31249163

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Project description:Background and aimsAlthough conventional EUS-guided FNA (EUS-FNA) has previously been considered first-line for sampling subepithelial lesions (SELs), variable accuracy has resulted in increased use of fine-needle biopsy (FNB) sampling to improve diagnostic yield. The primary aim of this study was to compare FNA versus FNB sampling for the diagnosis of SELs.MethodsThis was a multicenter, retrospective study to evaluate the outcomes of EUS-FNA and EUS-guided FNB sampling (EUS-FNB) of SELs over a 3-year period. Demographics, lesion characteristics, sensitivity, specificity, accuracy, number of needle passes, diagnostic adequacy of rapid on-site evaluation (ROSE), cell block accuracy, and adverse events were analyzed. Subgroup analyses were performed comparing FNA versus FNB sampling by location and diagnostic yield with or without ROSE. Multivariable logistic regression was also performed.ResultsTwo hundred twenty-nine patients with SELs (115 FNA and 114 FNB sampling) underwent EUS-guided sampling. Mean patient age was 60.86 ± 12.84 years. Most lesions were gastric in location (75.55%) and from the fourth layer (71.18%). Cell block for FNB sampling required fewer passes to achieve conclusive diagnosis (2.94 ± 1.09 vs 3.55 ± 1.55; P = .003). The number of passes was not different for ROSE adequacy (P = .167). Immunohistochemistry was more able to be successfully performed in more FNB sampling samples (69.30% vs 40.00%; P < .001). Overall, sensitivity and accuracy were superior for FNB sampling versus FNA (79.41% vs 51.92% [P = .001] and 88.03% vs 77.19% [P = .030], respectively). On subgroup analysis, sensitivity and accuracy of FNB sampling alone was superior to FNA + ROSE (79.03% vs 46.67% [P = .001] and 87.25% vs 68.00% [P = .024], respectively). There was no significant difference in diagnostic yield of FNB sampling alone versus FNB sampling + ROSE (P > .05). Multivariate analysis showed no predictors associated with accuracy. One minor adverse event was reported in the FNA group.ConclusionsEUS-FNB was superior to EUS-FNA in the diagnosis of SELs. EUS-FNB was also superior to EUS-FNA alone and EUS-FNA + ROSE. These results suggest EUS-FNB should be considered a first-line modality and may suggest a reduced role for ROSE in the diagnosis of SELs. However, a large randomized controlled trial is required to confirm our findings.

Project description:BACKGROUND:Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) was developed with the aim of further improving the diagnostic performance of endoscopic ultrasound. Although novel puncture needles have been specifically designed for collecting sufficient tissue specimens, clinical studies have indicated no clear difference in diagnostic performance between these novel needles and conventional puncture needles. Recently, a needle with Franseen geometry was developed specifically for EUS-FNA biopsy. Due to the characteristic shape of its tip, the Franseen needle is expected to be effective for scraping tissues, thus potentially increasing the diagnostic accuracy of EUS-FNA biopsy. We plan to carry out a prospective, multicenter, open-labeled, controlled trial to compare conventional and Franseen needles in terms of the diagnostic accuracy of EUS-FNA for evaluating the malignancy of pancreatic mass lesions. METHODS/DESIGN:The study will enroll 520 patients with pancreatic mass managed at any of 21 participating endoscopic centers. Lesion samples obtained using 22G conventional and Franseen needles will be assessed to compare the efficacy and safety of these two types of needles in EUS-FNA for evaluating the malignancy of mass lesions in the pancreas. Tissue samples will be fixed in formalin and processed for histologic evaluation. For the purpose of this study, only samples obtained with the first needle pass will be used for comparing the: (i) accuracy of the malignancy diagnosis, (ii) sensitivity and specificity for the malignancy diagnosis, (iii) procedure completion rate, (iv) sample cellularity, and (v) incidence of complications. Patient enrollment begins on July 17, 2018. DISCUSSION:The outcomes of this study may provide insight into the optimal needle choice for evaluating the malignancy of pancreatic solid lesions, thus aiding in the development of practice guidelines for pancreatic diseases. TRIAL REGISTRATION:University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000030634. Registered on 29 December 2017. http://www.umin.ac.jp/ Version number: 01.2017.12.28.

Dataset Information

Comparison of Franseen and fork-tip needles for EUS-guided fine-needle biopsy of solid mass lesions: A systematic review and meta-analysis.

Publications

Comparison of Franseen and fork-tip needles for EUS-guided fine-needle biopsy of solid mass lesions: A systematic review and meta-analysis.

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