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Comparative diagnostic accuracy of EUS needles in solid pancreatic masses: a network meta-analysis.

ABSTRACT: Background and study aims Endoscopic ultrasound (EUS)-guided tissue sampling is the standard of care for diagnosing solid pancreatic lesions. While many two-way comparisons between needle types have been made in randomized controlled trials (RCTs), it is unclear which size and type of needle offers the best probability of diagnosis. We therefore performed a network meta-analysis (NMA) to compare different sized and shaped needles to rank the diagnostic performance of each needle. Methods We searched MEDLINE, EMBASE and Cochrane Library databases through August, 2020 for RCTs that compared the diagnostic accuracy of EUS fine-needle aspiration (FNA) and biopsy (FNB) needles in solid pancreatic masses. Using a random-effects NMA under the frequentist framework, RCTs were analyzed to identify the best needle type and sampling technique. Performance scores (P-scores) were used to rank the different needles based on pooled diagnostic accuracy. The NMA model was used to calculate pairwise relative risk (RR) with 95 % confidence intervals. Results Review of 2577 studies yielded 29 RCTs for quantitative synthesis, comparing 13 different needle types. All 22G FNB needles had an RR > 1 compared to the reference 22G FNA (Cook) needle. The highest P-scores were seen with the 22G Medtronic FNB needle (0.9279), followed by the 22G Olympus FNB needle (0.8962) and the 22G Boston Scientific FNB needle (0.8739). Diagnostic accuracy was not significantly different between needles with or without suction. Conclusions In comparison to FNA needles, FNB needles offer the highest diagnostic performance in sampling pancreatic masses, particularly with 22G FNB needles.

SUBMITTER: Han S

PROVIDER: S-EPMC8159621 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Systematic Review and Meta-Analysis of Diagnostic Accuracy of Endoscopic Ultrasound (EUS)-Guided Fine-Needle Aspiration (FNA) Using 22-gauge and 25-gauge Needles for Pancreatic Masses.

Project description:BACKGROUND Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has been used for detecting pancreatic cancer. We aimed to compare the diagnostic yield of both 22-gauge and 25-gauge EUS-FNA for the detection of pancreatic cancer. MATERIAL AND METHODS We searched the electronic databases including PubMed, EMBASE, Web of Science, Scopus, and Cochrane Library up to June 13, 2017. Two reviewers independently screened studies and extracted data. RESULTS We analyzed data from 1824 patients from 16 included studies. The estimated pooled data for the 22-gauge needles reported sensitivity was 0.89 (0.83-0.93), specificity was 1.00 (0.74-1.00), positive LR was 485.28 (2.55-92 000) and negative LR was 0.11 (0.07-0.17). Results for the 25-gauge needles showed the pooled sensitivity, specificity, positive and negative LR was 0.90 (0.86-0.93), 0.99 (0.89-1.00), 59.53 (7.99-443.66), and 0.10 (0.07-0.14), respectively. The 25-gauge needle had significantly higher pooled sensitivity than the 22-gauge needle (0.90 vs. 0.87, ?²=5.26, P=0.02) while there was no difference in the pooled specificity (0.96 vs. 0.98, ?²=2.12, P=0.15). The quality of most studies was assessed favorable using QUADAS-2 (quality assessment of diagnostic accuracy studies-2). CONCLUSIONS Our findings revealed that the 25-gauge EUS-FNA used for pancreatic lesions could have a higher diagnostic yield than using 22-gauge EUS-FNA. Nevertheless, well-designed prospective studies recruiting more patients are needed.

| S-EPMC6257123 | biostudies-literature

Multicenter, randomized comparison of the diagnostic accuracy of 19-gauge stainless steel and nitinol-based needles for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic masses.

Project description:BACKGROUND:The use of 19-gauge (G) stainless steel needles for endoscopic ultrasound-guided fine-needle biopsy of a pancreatic mass often results in technical difficulties due to an inability to advance the relatively rigid needle out of the endoscope. More flexible nitinol-based needles might decrease such technical difficulties and thus increase diagnostic accuracy. OBJECTIVE:In this prospective multicenter randomized single-blinded study we compared the diagnostic value of those two needle types in patients with a solid pancreatic lesion. METHODS:Patients with a solid pancreatic mass were diagnosed with endoscopic ultrasound-guided fine-needle biopsy using one puncture with each needle in a randomized fashion. The primary endpoint was the diagnostic accuracy of each needle. Secondary endpoints included time for puncture, amount of tumour tissue obtained, and technical failure. Histological specimens were centrally reviewed by a pathologist blinded to the final needle type and final diagnosis (ClinicalTrials.gov Identifier: NCT02909530). RESULTS:Out of 46 prospectively recruited patients, central pathological examination was available for 41. Diagnostic accuracy for the two needles combined was 87.8%. Diagnostic accuracy was 66% and 68% using the stainless steel- and nitinol-based needle respectively. Time spent for puncturing was 137?±?61?s (mean?±?standard deviation) for the stainless steel and 111?±?53?s for the nitinol-based needle (p?=?0.037). Technical failure occurred in three (6.5%) cases using the stainless steel- and in none using the nitinol-based needle. CONCLUSIONS:Usage of a nitinol-based 19-G needle failed to present a significant superior accuracy compared with a stainless steel needle in endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions.

| S-EPMC7184661 | biostudies-literature

Diagnostic performance and factors influencing the accuracy of EUS-FNA of pancreatic neuroendocrine neoplasms.

Project description:BackgroundMultiple studies have investigated sampling adequacy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for pancreatic neuroendocrine neoplasms (pNENs). However, none have described the diagnostic performance of EUS-FNA for pNENs, or the influencing factors. The aim of this study was to evaluate the diagnostic accuracy of EUS-FNA, with post-operative pathological diagnosis as the gold standard, and factors predictive of inadequate EUS sampling.MethodsFrom 1998 to 2014, a total of 698 patients underwent pancreatic resection and 1455 patients underwent EUS-FNA sampling for pancreatic lesions. A total of 410 cases underwent both surgical resection and preceding EUS-FNA. Of these, 60 cases (49 true pNEN, nine non-diagnostic, two misdiagnoses) were included. We studied diagnostic performance of EUS-FNA and factors that were associated with failed diagnosis.ResultsOf the 60 cases, EUS-FNA yield was 49 true-positive cases, two misdiagnoses, and nine non-diagnostic cases (including six suggestive cases). Sensitivity, specificity, and accuracy were 84.5, 99.4, and 97.3 %, respectively; including the six suggestive cases, diagnostic values were 94.8 % sensitivity (55/58), 99.4 % specificity (350/352), and 98.7 % accuracy (405/410). In multivariate analysis, sampling adequacy rates were significantly lower when lesions were located in the pancreatic head [odds ratio (OR) = 10.0] and in tumor-rich stromal fibrosis (OR = 10.45). Tumor size, needle type, tumor grading, presence of cystic component, and time period were not significant factors.ConclusionsEUS-FNA offers high accuracy for pNEN. However, location of the tumor in the pancreatic head and presence of rich stromal fibrosis negatively impacts sampling adequacy.

| S-EPMC4990623 | biostudies-literature

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

Project description:Background and objectiveRobust 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 methodsComputerized 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.ResultsA 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).ConclusionOur 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.

| S-EPMC7430907 | biostudies-literature

Additional K-ras mutation analysis and Plectin-1 staining improve the diagnostic accuracy of pancreatic solid mass in EUS-guided fine needle aspiration.

Project description:One of the major genetic alterations in pancreatic ductal adenocarcinoma (PDAC) is the point mutation of K-ras gene. Plectin-1 was also recently identified as PDAC specific biomarker. The aim of this study was to investigate the improvement of diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) by using additional K-ras mutation analysis and Plectin-1 staining in patients with pancreatic mass.A total of 85 study patients with pancreatic mass underwent EUS-FNA and the final diagnoses were as follows; PDACs: 70 patients, pancreas neuroendocrine tumor: 4, metastasis to pancreas: 5, autoimmune pancreatitis: 3, chronic pancreatitis: 1, tuberculous lymphadenitis: 1, pseudocyst: 1.Sensitivity, specificity and accuracy of pathologic diagnosis in EUS-FNA specimen were 81%, 80% and 79% accordingly. When we combine K-ras gene mutation analysis with histological assessment, we could get the following results for sensitivity, specificity and accuracy; cytology and K-ras mutation analysis: 93%, 87%, and 92%, cytology, K-ras mutation analysis, and Plectin-1 staining: 96%, 93%, and 95%.Triple combinations of the techniques; cytology, K-ras gene mutation analysis, Plectin-1 staining could increase accuracy in diagnosis of PDACs. Further investigation of using minimal specimens from EUS-FNA may give us insight to understand the biological behavior of PDAC.

| S-EPMC5610015 | biostudies-other

Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions.

Project description:BackgroundTo overcome limitations of cytology, biopsy needles have been developed to procure histologic samples during EUS.ObjectiveTo compare 22-gauge (G) FNA and 22G biopsy needles (FNB) for EUS-guided sampling of solid pancreatic masses.DesignRandomized trial.SettingTertiary-care medical center.PatientsThis study involved 56 patients with solid pancreatic masses.InterventionSampling of pancreatic masses by using 22G FNA or 22G FNB devices.Main outcome measurementsCompare the median number of passes required to establish the diagnosis, diagnostic sufficiency, technical performance, complication rates, procurement of the histologic core, and quality of the histologic specimen.ResultsA total of 28 patients were randomized to the FNA group and 28 to the FNB group. There was no significant difference in median number of passes required to establish the diagnosis (1 [interquartile range 1-2.5] vs 1 [interquartile range 1-1]; P = .21), rates of diagnostic sufficiency (100% vs 89.3%; P = .24), technical failure (0 vs 3.6%; P = 1.0), or complications (3.6% for both) between FNA and FNB needles, respectively. Patients in whom diagnosis was established in passes 1, 2, and 3 were 64.3% versus 67.9%, 10.7% versus 17.9%, and 25% versus 3.6%, respectively, for FNA and FNB cohorts. There was no significant difference in procurement of the histologic core (100% vs 83.3%; P = .26) or the presence of diagnostic histologic specimens (66.7% vs 80%; P = .66) between FNA and FNB cohorts, respectively.LimitationsOnly pancreatic masses were evaluated.ConclusionDiagnostic sufficiency, technical performance, and safety profiles of FNA and FNB needles are comparable. There was no significant difference in yield or quality of the histologic core between the 2 needle types.

| S-EPMC4148209 | biostudies-literature

Prospective randomized comparison of a 22G core needle using standard versus capillary suction for EUS-guided sampling of solid pancreatic masses.

Project description:BACKGROUND AND STUDY AIMS:?The optimal technique for sampling pancreatic lesions with a 22?G Procore needle (pc) is unknown. The aims of this study were to evaluate the 22?Gpc using standard suction technique (SST) and capillary suction technique (CST) and compare diagnostic adequacy of 22?Gpc with the standard 25?G needle. PATIENTS AND METHODS:?Sixty consecutive patients referred for EUS-FNA of a solid pancreatic mass were prospectively evaluated. All patients underwent 2 passes with a standard 25?G needle for cytologic analysis. The first group of 30 patients underwent a single pass with the 22?Gpc needle using SST for cytology and histology. The second group underwent a single pass with the 22?Gpc needle using CST. The sequence of passes was randomized. The diagnostic adequacy of each pass was graded by 2 cytopathologists blinded to technique and needle type for comparison. RESULTS:?For a cytologic diagnosis with 22?Gpc, an adequate sample was obtained in 82.8?% SST vs. 80.0?% CST ( P ?=?0.79). For a histologic diagnosis with 22?Gpc, an adequate sample was obtained in 70.4?% SST vs. 69.0?% CST ( P ?=?0.91). A single pass with 22?Gpc provided comparable results to a single pass with the 25?G needle for a cytologic diagnosis; both were superior to a single 22?Gpc pass for a histologic diagnosis. Two passes with the 25?G needle provided a diagnostic specimen in 95.0?% vs 81.4?% with one pass using 22?Gpc ( P ?=?0.01). CONCLUSIONS:?No significant difference in diagnostic adequacy was observed between techniques for the 22?Gpc. Two passes with a 25?G needle performed better than 1 pass with 22?Gpc. (NCT01598194).

| S-EPMC5462609 | biostudies-literature

Prospective Study for Comparison of Endoscopic Ultrasound-Guided Tissue Acquisition Using 25- and 22-Gauge Core Biopsy Needles in Solid Pancreatic Masses.

Project description:BACKGROUND AND AIMS:Although thicker needles theoretically allow more tissue to be collected, their decreased flexibility can cause mechanical damage to the endoscope, technical failure, and sample blood contamination. The effects of needle gauge on diagnostic outcomes of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) of pancreatic mass lesions remain unknown. This study compared procurement rates of histologic cores obtained from EUS-FNB of pancreatic masses using 25- and 22-gauge core biopsy needles. PATIENTS AND METHODS:From March 2014 to July 2014, 66 patients with solid pancreatic mass underwent EUS-FNB with both 25- and 22-gauge core biopsy needles. Among them, 10 patients were excluded and thus 56 patients were eligible for the analyses. Needle sequences were randomly assigned, and two passes were made with each needle, consisting of 10 uniform to-and-fro movements on each pass with 10 mL syringe suction. A pathologist blinded to needle sequence evaluated specimens for the presence of histologic core. RESULTS:The mean patient age was 65.8 ± 9.5 years (range, 44-89 years); 35 patients (62.5%) were men. The mean pancreatic mass size was 35.3 ± 17.1 mm (range 14-122.3 mm). Twenty-eight patients (50%) had tumors at the pancreas head or uncinate process. There were no significant differences in procurement rates of histologic cores between 25-gauge (49/56, 87.5%) and 22-gauge (46/56, 82.1%, P = 0.581) needles or diagnostic accuracy using only histologic cores (98% and 95%). There were no technical failures or procedure-related adverse events. CONCLUSIONS:The 25-gauge core biopsy needle could offer acceptable and comparable outcomes regarding diagnostic performance including histologic core procurement rates compared to the 22-gauge core biopsy needle, although the differences were not statistically significant. TRIAL REGISTRATION:ClinicalTrials.gov NCT01795066.

| S-EPMC4858215 | biostudies-literature

Diagnostic accuracy of EUS-FNA in the evaluation of pancreatic neuroendocrine neoplasms grading: Possible clinical impact of misclassification.

Project description:Background and objectivesPrognosis of pancreatic neuroendocrine neoplasms (PanNENs) mostly depend on tumor stage and grade, determined by Ki-67 labeling index. EUS-FNA is considered the gold-standard technique to obtain it. The aims of our study were to establish diagnostic accuracy of preoperative EUS-FNA Ki-67 evaluation considering final pathological assessment on surgical specimen as gold standard and to investigate the possible impact on prognosis of misclassification.MethodsThis is a retrospective study from a prospectively collected database. EUS-FNA grading (eG) and surgical one (sG) measured according to Ki-67 proliferative index values, according to 2017 WHO classification, were compared. eG-sG correlation was evaluated by Spearman index. Logistic regression investigated factors associated with misclassification. Prognostic difference in terms of progression-free survival was evaluated by Kaplan Meier method.ResultsOne hundred and twelve PanNENs patients enrolled. In 13.4% of patients (15/112) EUS-FNA "undergraded" patients (eG1 vs. sG2), while in 12.5% (n = 14) it "overgraded" PanNENs (eG2 to sG1). No misclassifications in G3 patients. In patients with tumors <20 mm (n = 44), 2 (4.5%) eG1 and 10 (22.7%) eG2 were finally classified respectively as G2 and G1 at surgical histology. No factors, as i.e. the lesions' size or their morphological aspect, were associated with misclassification. In overgraded PanNENs, no progression occurred, while in patients correctly classified/undergraded the progression rate was 14.3%.ConclusionsThis is the largest cohort of surgical PanNENs with preoperative EUS-FNA grading evaluation. Despite an acceptable eG-sG correlation, about 25% of patients are misclassified. Clinical impact of misclassification should be carefully considered especially in small tumors undergoing observation.

| S-EPMC8544016 | biostudies-literature

Comparing the diagnostic accuracy of five common tumour biomarkers and CA19-9 for pancreatic cancer: a protocol for a network meta-analysis of diagnostic test accuracy.

Project description:INTRODUCTION:Surgical resection is the only curative treatment for patients with resectable pancreatic cancer. Unfortunately, 80%-85% of patients present with locally advanced or metastatic unresectable pancreatic cancer at the time of diagnosis. Detection of pancreatic cancer at early stages remains a great challenge due to lack of accurate detection tests. Recommendations in existing clinical practice guidelines on early diagnosis of pancreatic cancer are inconsistent and based on limited evidence. Most of them endorse measuring serum CA19-9 as a complementary test, but also state that it is not recommended for diagnosing early pancreatic cancer. There are currently no other tumour-specific markers recommended for diagnosing early pancreatic cancer. This study aims to evaluate and compare the accuracy of five common tumour biomarkers (CA242,carcino-embryonic antigen (CEA)), CA125, microRNAs and K-ras gene mutation) and CA19-9 and their combinations for diagnosing pancreatic cancer using network meta-analysis method, and to rank these tests using a superiority index. METHODS AND ANALYSIS:PubMed, EMBASE and the Cochrane Central Register of Controlled Trials will be searched from inception to April 2017. The search will include the above-mentioned tumour biomarkers for diagnosing pancreatic cancer, including CA19-9. The risk of bias for each study will be independently assessed as low, moderate or high using criteria adapted from the Quality Assessment of Diagnostic Accuracy Studies 2. Network meta-analysis will be performed using STATA V.12.0 and R software V.3.4.1. The competing diagnostic tests will be ranked by a superiority index. ETHICS AND DISSEMINATION:Ethical approval and patient consent are not required since this study is a network meta-analysis based on published studies. The results of this network meta-analysis will be submitted to a peer-reviewed journal for publication. PROSPERO REGISTRATION NUMBER:CRD42017064627.

| S-EPMC5770961 | biostudies-literature

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