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Endoscopic ultrasound-guided fine needle aspiration of pancreatic lesions with 22 versus 25 Gauge needles: A meta-analysis.

ABSTRACT: Robust data in favour of a clear superiority of 22 versus 25 Gauge needles for endoscopic ultrasound-guided fine needle aspiration are still lacking.We aimed to compare the diagnostic sensitivity, specificity and safety of these two needles for endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions.A computerized bibliographic search was restricted to randomized controlled trials only. Pooled effects were calculated using a random-effects model and expressed in terms of risk ratio and 95% confidence interval.We analysed seven trials with 689 patients and 732 lesions (295 sampled with 22 Gauge needle, 309 with 25 Gauge needle, and 128 with both needles). A non-significant superiority of 25 Gauge in terms of pooled sensitivity (risk ratio: 0.93, 0.91-0.95 versus 0.89, 0.85-0.94 of 22 Gauge needle; p?=?0.13) and no difference in terms of specificity (1.00, 0.98-1.00 in both groups; p?=?0.85) were observed. Sample adequacy was similar between the two devices (risk ratio: 1.03, 0.99-1.06; p?=?0.15). Very few adverse events were observed and did not impact on patient outcomes.Our meta-analysis reveals non-superiority of 25 Gauge over 22 Gauge; hence no definitive recommendations over the use of one particular device can be made.

SUBMITTER: Facciorusso A

PROVIDER: S-EPMC5625867 | biostudies-other | 2017 Oct

REPOSITORIES: biostudies-other

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Endoscopic ultrasound-guided fine needle aspiration of pancreatic lesions with 22 versus 25 Gauge needles: A meta-analysis.

Facciorusso Antonio A Stasi Elisa E Di Maso Marianna M Serviddio Gaetano G Ali Hussein Mohammed Salah MS Muscatiello Nicola N

United European gastroenterology journal 20161117 6

<h4>Background</h4>Robust data in favour of a clear superiority of 22 versus 25 Gauge needles for endoscopic ultrasound-guided fine needle aspiration are still lacking.<h4>Objective</h4>We aimed to compare the diagnostic sensitivity, specificity and safety of these two needles for endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions.<h4>Methods</h4>A computerized bibliographic search was restricted to randomized controlled trials only. Pooled effects were calculated us ...[more]

PMID: 29026598

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Project description:Background and Objectives: Endoscopic ultrasound (EUS) fine needle biopsy (FNB) needles were designed to improve histologic yield, while maintaining the flexibility to permit ease of use. However, the diagnostic benefit of EUS-FNB needles as compared to the conventional fine needle aspiration (FNA) needles remains unclear. This study aimed to identify the diagnostic accuracy of combined needle use of a new 20-gauge ProCore FNB needle and a 25-gauge FNA needle. Methods: For this study, cases were selected in which both the 20-gauge ProCore FNB needle and the 25-gauge FNA needle were used during a single EUS procedure for sampling of a solid pancreatic mass, lymph node, or submucosal mass. Tissue acquisition was performed in the course of the ASPRO trial, a multicenter randomized study comparing the diagnostic value of 20-gauge ProCore FNB and 25-gauge FNA needles (ClinicalTrials.gov: NCT02167074). The protocol allowed additional sampling with the nonassigned needle, at the discretion of an endosonographer. Results: Of all 615 patients who were randomized for the ASPRO study, 74 were sampled with both needle types. In these combined needle cases, FNA was used first in 24 and ProCore FNB in 50 cases. Target lesions encompassed 39 solid pancreatic lesions, 18 submucosal masses, and 17 lymph nodes. Most pancreatic lesions were located in the head (25/39), lymph nodes were mainly located in the abdomen (15/18), and submucosal lesions were located in the stomach (8/20), esophagus (4/20), small intestines (3/20), and rectum (3/20). The main reason to use ProCore in addition to FNA was to collect more tissue for ancillary testing (79%). FNA was generally used in addition to ProCore to allow for on-site pathological assessment (76%). The regimen of FNA followed by ProCore resulted in 100% accuracy, while for ProCore followed by FNA, 88% was reached (P = 0.086). The type of target lesion, either pancreatic or nonpancreatic, did not affect the diagnostic accuracy of the two sampling regimens (odds ratio 1.2, 95% confidence interval 0.22–6.61, P = 0.834). Conclusion: FNA followed by ProCore FNB provides for a 100% diagnostic accuracy and tends to outperform ProCore FNB followed by FNA. Accuracy rates were independent of the type of target lesion.

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

Endoscopic ultrasound-guided fine needle aspiration of pancreatic lesions with 22 versus 25 Gauge needles: A meta-analysis.

Publications

Endoscopic ultrasound-guided fine needle aspiration of pancreatic lesions with 22 versus 25 Gauge needles: A meta-analysis.

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