Dataset Information

Comparison between 22G aspiration and 22G biopsy needles for EUS-guided sampling of pancreatic lesions: A meta-analysis.

ABSTRACT:

Background and objective

Robust data in favor of clear superiority of 22G fine-needle biopsy (FNB) over 22G FNA for an echoendoscopic-guided sampling of pancreatic masses are lacking. The objective of this study is to compare the diagnostic outcomes and sample adequacy of these two needles.

Materials and methods

Computerized bibliographic search on the main databases was performed and restricted to only randomized controlled trials. Summary estimates were expressed regarding risk ratio (RR) and 95% confidence interval.

Results

A total of 11 trials with 833 patients were analyzed. The two needles resulted comparable in terms of diagnostic accuracy (RR 1.02, 0.97-1.08; P = 0.46), sample adequacy (RR 1.01, 0.96-1.06; P = 0.61), and histological core procurement (RR 1.01, 0.89-1.15; P = 0.86). Pooled sensitivity in the diagnosis of pancreatic cancer was 93.1% (87.9%-98.4%) and 90.4% (86.3%-94.5%) with biopsy and aspirate, respectively, whereas specificity for detecting pancreatic cancer was 100% with both needles. Analysis of the number of needle passes showed a nonsignificantly positive trend in favor of FNB (mean difference: -0.32, -0.66-0.02; P = 0.07).

Conclusion

Our meta-analysis stands for a nonsuperiority of 22G FNB over 22G FNA; hence, no definitive recommendations on the use of a particular device can be made.

SUBMITTER: Facciorusso A

PROVIDER: S-EPMC7430907 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.