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Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial.

ABSTRACT: BACKGROUND AND STUDY AIM:Standard endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) procedures involve use of no-suction or suction aspiration techniques. A new aspiration method, the stylet slow-pull technique, involves slow withdrawal of the needle stylet to create minimum negative pressure. The aim of this study was to compare the sensitivity of EUS-FNA using stylet slow-pull or suction techniques for malignant solid pancreatic lesions using a standard 22-gauge needle. PATIENTS AND METHODS:Consecutive patients presenting for EUS-FNA of pancreatic mass lesions were randomized to the stylet slow-pull or suction techniques using a 22-gauge needle. Both techniques were standardized for each pass until an adequate specimen was obtained, as determined by rapid on-site cytology examination. Patients were crossed over to the alternative technique after four nondiagnostic passes. RESULTS:Of 147 patients screened, 121 (mean age 64?±?13.8 years) met inclusion criteria and were randomized to the stylet slow-pull technique (n?=?61) or the suction technique (n?=?60). Technical success rates were 96.7?% and 98.3?% in the slow-pull and suction groups, respectively (P?>?0.99). The sensitivity for malignancy of EUS-FNA was 82?% in the slow-pull group and 69?% in the suction group (P?=?0.10). The first-pass diagnostic rate (42.6?% vs. 38.3?%; P?=?0.71), acquisition of core tissue (60.6?% vs. 46.7?%; P?=?0.14), and the median (range) number of passes to diagnosis (2 1 2 3 vs. 1 1 2; P?=?0.71) were similar in the slow-pull and suction groups, respectively. CONCLUSIONS:The stylet slow-pull and suction techniques both offered high and comparable diagnostic sensitivity with a mean of 2 passes required for diagnosis of solid pancreatic lesions. The endosonographer may choose either technique during FNA.

SUBMITTER: Saxena P

PROVIDER: S-EPMC6441969 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial.

Saxena Payal P El Zein Mohamad M Stevens Tyler T Abdelgelil Ahmed A Besharati Sepideh S Messallam Ahmed A Kumbhari Vivek V Azola Alba A Brainard Jennifer J Shin Eun Ji EJ Lennon Anne Marie AM Canto Marcia I MI Singh Vikesh K VK Khashab Mouen A MA

Endoscopy 20171222 5

<h4>Background and study aim</h4>Standard endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) procedures involve use of no-suction or suction aspiration techniques. A new aspiration method, the stylet slow-pull technique, involves slow withdrawal of the needle stylet to create minimum negative pressure. The aim of this study was to compare the sensitivity of EUS-FNA using stylet slow-pull or suction techniques for malignant solid pancreatic lesions using a standard 22-gauge needle.<h4> ...[more]

PMID: 29272906

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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.

Project description:BackgroundEndobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a widely used, safe, and accurate technique for obtaining pathological specimens to be used in the diagnosis of diseases involving lung hilar and mediastinal lymph node (LN) enlargement. However, application of the suction technique during EBUS-TBNA remains controversial. In addition, the effectiveness of the slow-pull capillary technique for the diagnosis of pancreatic masses was recently reported. The aim of this study was to compare the diagnostic accuracy of EBUS-TBNA using these two techniques.MethodsThe accuracy, sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and availability of tissue cores of the suction and slow-pull capillary techniques were studied retrospectively in patients who underwent EBUS-TBNA for the diagnosis of diseases involving lung hilar and mediastinal LN enlargement.ResultsA total of 97 patients with hilar and mediastinal LN enlargement underwent EBUS-TBNA; 30 patients underwent the suction technique, 56 patients underwent the slow-pull capillary technique, 5 patients underwent both techniques, and 6 patients had failed operations. The accuracy, sensitivity, specificity, NPV, PPV, and the number of tissue cores obtained with the suction and slow-pull capillary techniques were 66.67% versus 85.71% (p = 0.039), 43.75% versus 85.42% (p < 0.001), 92.86% versus 87.5% (p > 0.05), 59.09% versus 50% (p > 0.05), 87.5% versus 97.62% (p > 0.05), and 19 versus 50 (p = 0.004), respectively. In both univariate and multivariate analyses, the acquisition of tissue core was significantly associated with the diagnostic accuracy of EBUS-TBNA. Moreover, the slow-pull capillary technique was significantly associated with the acquisition of tissue core in EBUS-TBNA. There were no significant differences between the two groups in the blood contamination of samples.ConclusionsUse of the slow-pull capillary technique in EBUS-TBNA can significantly increase the accuracy related to the diagnosis of diseases involving hilar and mediastinal LN enlargement by improving the acquisition of tissue core. The reviews of this paper are available via the supplemental material section.

Dataset Information

Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial.

Publications

Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial.

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