Diagnostic Accuracy For Malignancy Research Articles

EUS-guided fine-needle biopsy sampling of solid pancreatic tumors with 3 versus 12 to-and-fro movements: a multicenter prospective randomized controlled study.

A novel EUS-guided fine-needle biopsy sampling (EUS-FNB) needle enabled physicians to obtain sufficient pathologic samples with fewer to-and-fro movements (TAFs) within the lesion. We compared the diagnostic yields of EUS-FNB with 3 and 12 TAFs at each puncture pass. The primary endpoint of this multicenter, noninferiority, crossover, randomized controlled trial involving 6 centers was diagnostic sensitivity. Secondary endpoints were diagnostic accuracy and quantity and quality evaluation of EUS-FNB specimens. Length of the macroscopically visible core (MVC) and microscopic histologic quantity were used for quantitative evaluation. Macroscopic visual and microscopic histologic evaluations were performed for qualitative evaluation. Among 110 patients (220 punctures, 110 for 3 TAFs and 12 TAFs each), 105 (210 punctures) had malignant histology. Diagnostic sensitivity for malignancy of 3 TAFs (88.6%) was not inferior to that of 12 TAFs (89.5%; difference, -.9%; 95% confidence interval, -9.81 to 7.86). Diagnostic accuracy for malignancy was 92.7% for 3 TAFs and 94.6% for 12 TAFs. Overall median MVC length was 13.5mm in both groups. The 3-TAF group had a significantly higher rate of score≥3 on macroscopic visual quality evaluation than the 12-TAF group (71.8% vs 52.7%, P= .009). No significant intergroup differences existed in microscopic histologic quantity and quality evaluations (quantity evaluation, 88.2% for 3 TAFs vs 83.6% for 12 TAFs; quality evaluation, 90.0% for 3 TAFs vs 89.1% for 12 TAFs). Diagnostic sensitivity and accuracy of EUS-FNB with 3 TAFs were not inferior to those with 12 TAFs for solid pancreatic lesions. The 3-TAF group showed significantly less blood contamination in sampled tissues than the 12-TAF group. (Clinical trial registration number: UMIN000037309.).

Prediction of thyroid nodule histopathology by expert ultrasound evaluation.

ObjectiveThe basis of thyroid nodule diagnostics is ultrasound-guided fine needle biopsy with cytological evaluation (FNC) if ultrasound appearance is not clearly benign. The aim of this study was to investigate the predictive potential of dedicated, expert high-resolution ultrasound, to see if histopathological entities of thyroid nodules can be diagnosed without invasive FNC biopsies.DesignProspective case-cohort study.Methods187 patients with 221 thyroid nodules were examined with ultrasound and prospectively assigned to the expected histopathological diagnosis: colloid nodule, adenomatoid colloid nodule, follicular adenoma, follicular carcinoma, follicular variant of papillary thyroid carcinoma, papillary thyroid carcinoma, or other thyroid cancer. In 101 of these, we later obtained histopathological reports for comparison.ResultsOverall accuracy for classification into discrete histopathological categories by expert ultrasound was 71.3% and Cohen’s Kappa was 0.62. The sensitivity and specificity for detecting malignancy were 97.3% and 78.1%. The diagnostic accuracy for malignancy was 85.1%. ACR-TIRADS scores for the same nodules had a sensitivity of 97.3%, specificity of 26.6%, and accuracy of 52.5%.ConclusionDedicated expert high-resolution ultrasound without FNC can reliably distinguish benign vs malignant nodules, but also differentiate between several histopathological entities in thyroid nodules. There is potential for a reduction in the number of invasive FNC biopsies and diagnostic operations.

Diagnostic Concordance of Cytology and Histology in Samples Obtained via Endoscopic Ultrasound-Guided Fine-Needle Biopsy (EUS-FNB).

IntroductionEndoscopic ultrasound (EUS)-guided fine-needle aspiration and biopsy (FNA/FNB) to obtain cytological aspirates and histological core samples, respectively, are the standard of care for diagnosing lesions in/adjacent to the upper/lower gastrointestinal tract. Due to the lack of standardization of tissue processing, it is unclear whether core samples should be sent only for histology (formalin) or cytology (CytoLyt), or both. The aim of this study was to investigate the diagnostic concordance rates between cytology and histology on EUS-FNB core samples.MethodsA total of 227 patients underwent EUS-FNB between October-2017 and February-2019 by a single therapeutic endoscopist; 44 core-tissue samples (41 patients) were placed alternately in CytoLyt (cytology) and formalin (histology), with equal passes into each, to best achieve a proportionate sample amount. The patient's demographics, medical history, pertinent imaging, EUS indication/findings were reviewed. Main outcomes included concordance rates between cytology-histology and diagnostic accuracy for malignancy.ResultsCytology and histology were discordant in five cases (11.5%); four with negative cytology but a definite diagnosis of malignancy achieved with histology. One case was suspected as neoplasm on cytology but further characterized as benign on histology. Cytology failed to sub-characterize an additional four mass-like pancreatic benign entities, due to inadequate tissue architecture assessment in the CytoLyt sample. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of cytology for diagnosis of malignancy were 87.88% (95%CI: 71.8-96.6), 90.91% (95%CI: 58.7-99.7), 96.67% (95%CI: 81.6-99.4), and 71.43% (95%CI: 49.4-86.4).DiscussionWe observed 11.5% diagnostic discordance between cytology and histology on EUS-FNB core samples, with histology being superior. Future multicenter prospective randomized studies are needed to establish an accurate and cost-effective diagnostic process.

Effectiveness of Cytological Diagnosis with Outer Cannula Washing Solution for Computed Tomography-Guided Needle Biopsy

We evaluated the availability of cytological diagnosis with outer cannula washing solution (C-OCWS) as a clinical diagnostic tool for computed tomography (CT)-guided needle biopsy. We retrospectively assessed 109 consecutive patients (71 males, 38 females; median age 68 years), who underwent CT-guided needle biopsy. In all patients, the specimens sampled by the inner needle were used for histological diagnosis, and those taken from the outer cannula were rinsed with 0.9% saline solution: outer cannula washing solution for cytological diagnosis. The accuracy of C-OCWS in addition to histological diagnosis were compared with that of histological diagnosis alone. We used binary logistic regression analysis to determine the variables associated with diagnostic accuracy for malignancy and lesion characteristics. The C-OCWS method precisely diagnosed 7 (6.4%) malignant lesions (i.e., effective cases) in the 109 patients characterized as "negative for malignancy" via histological diagnosis alone. The accuracy of the combination of C-OCWS and histological diagnoses was significantly higher than that of histological diagnosis alone (0.95 vs. 0.89, respectively; p = 0.023). Multivariate logistic regression analysis showed that increasing only a marginal ratio (failure rate for proper position of biopsy needle within the tumor) was independently associated with a high rate of effective cases (p = 0.003). C-OCWS may be helpful for improving the quality of CT-guided needle biopsy, and is a simple method that may not necessarily increase the patients' physical burden.

Endoscopic ultrasound-guided fine-needle aspiration of pelvic lesions via the upper and lower gastrointestinal tract approaches

BackgroundCombining upper and lower gastrointestinal tract (GI) approaches allows expansion of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) indications for pelvic lesions. The upper GI approach has been used for pelvic lesions around the level of the aortoiliac bifurcation in our institution. The aim of this study is to evaluate the feasibility and safety of EUS-FNA for pelvic lesions via the upper and lower GI approaches.MethodsAll consecutive patients who underwent EUS-FNA for the pelvic lesion between January 2008 and December 2018 were retrospectively analyzed. Pelvic lesions were defined as lesions located around and below the aortoiliac bifurcation level. The primary outcome was technical success rate, and the secondary outcomes were the diagnostic capability of EUS-FNA for malignancy and the safety.ResultsEUS-FNA for pelvic lesions was performed in 49 patients: upper and lower GI approaches were used in 28 and 21 patients, respectively. The technical success rates were 91.8% (45/49) in all patients: 89.3% (25/28) and 95.2% (20/21) with the upper and lower GI approaches, respectively. Among patients who achieved technical success, the diagnostic accuracy for malignancy was 97.8% (44/45) in all patients: 100% (25/25) and 95.0% (19/20) with the upper and lower GI approaches, respectively. One (2.0%) patient developed an adverse event of sigmoid colon perforation.ConclusionsEUS-FNA for pelvic lesions via the upper and lower GI approaches was a safe, feasible, and effective method, although careful endoscopic manipulation is required to avoid perforation, especially with the lower GI approach. Further large-scale, well-designed studies are needed to validate our findings.

Optimizing cytological specimens of EUS-FNA of solid pancreatic lesions: A pilot study to the effect of a smear preparation training for endoscopy personnel on sample quality and accuracy.

BackgroundIn the absence of rapid on‐side pathological evaluation, endoscopy staff generally “smears” endoscopic ultrasound guided fine needle aspiration (EUS‐FNA) specimens on a glass slide. As this technique is vulnerable to preparation artifacts, we assessed if its quality could be improved through a smear‐preparation‐training for endoscopy staff.MethodsIn this prospective pilot study, 10 endosonographers and 12 endoscopy nurses from seven regional EUS‐centers in the Netherlands were invited to participate in a EUS‐FNA smear‐preparation‐training. Subsequently, post training slides derived from solid pancreatic lesions were compared to pre‐training “control” slides. Primary outcome was to assess if the training positively affects smear quality and, consequently, diagnostic accuracy of EUS‐FNA of solid pancreatic lesions.ResultsParticipants collected and prepared 71 cases, mostly pancreatic head lesions (48%). Sixty‐eight controls were selected from the pretraining period. The presence of artifacts was comparable for smears performed before and after training (76% vs 82%, P = .36). Likewise, smear cellularity (≥50% target cells) before and after training did not differ (44% (30/68) vs 49% (35/71), P = .48). Similar, no difference in diagnostic accuracy for malignancy was detected (P = .10). Conclusion In this pilot EUS‐FNA smear‐preparation‐training for endoscopy personnel, smear quality and diagnostic accuracy were not improved after the training. Based on these results, we plan to further study other training programs and possibilities.

Su1297 ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE BIOPSY: DIAGNOSTIC ACCURACY OF CYTOLOGY AND HISTOLOGY

Endoscopic ultrasound (EUS)-guided fine needle aspiration/biopsy (EUS-FNA/FNB) to obtain cytological aspirates and histological core samples have been the standard of care for diagnosis of solid or cystic lesions in or nearby upper and lower gastrointestinal tract. Due to lack of standardization of tissue processing, it is unclear as to whether core sample should be sent only for histology (in formalin), or for cytology (in cytolyte) or for both. The aim of this study is to investigate the concordance rates observed between cytology compared with histology on samples obtained using EUS-FNA/FNB. Out of 226 patients who underwent EUS-FNA/FNB using a 22-gauge needle between October 2017 and February 2019 by a single therapeutic endoscopist, 46 patients were selected for final evaluation, in whom equal number of passes were sent for both histology and cytology. Patient's demographics, medical history, imaging (prior computed tomography /magnetic resonance imaging), indication for EUS, EUS findings, and cytology/histology results were analyzed. The main outcome measures were diagnostic accuracy for malignancy and concordance between cytology and histology. In 46 patients, the acquired core samples were placed alternately in cytolyte (for cytology) and formalin (for histology), with equal number of passes into each, to best achieve proportionate amount of samples. These samples were obtained from solid masses in 78% (36/46), lymph nodes in 13% (6/46) and from cystic lesions in 8.6% (4/46) of cases. Analysis was remarkable for diagnosis consistency in 42 out of 46 samples (91.3%). Cytology and histology were found to be discordant in four cases. Cytology was reported inconclusive in 1 and negative in 3 of these cases, but definitive diagnosis was achieved with histology, which was positive for neoplasm in all 4 cases. These samples were obtained from two pancreatic masses, one gastric subepithelial lesion, and one lymph node; and histology confirmed pancreatic adenocarcinoma, gastrointestinal stromal tumor, and follicular lymphoma, respectively. Our study observed an 8% diagnostic discordance between cytology and histology on core samples obtained using EUS-FNB, when it was sent for both cytology and histology in equal proportions. Diagnostic yield of histology was noted to be superior to cytology, especially in cases with cytological diagnostic uncertainty. Further large, randomized and prospective studies are needed to ascertain a best and universally acceptable practice to make the diagnostic process more efficient, accurate, and cost-effective.

Combined versus single use 20 G fine-needle biopsy and 25 G fine-needle aspiration for endoscopic ultrasound-guided tissue sampling of solid gastrointestinal lesions

Instead of choosing one endoscopic ultrasound (EUS) needle over the other, some advocate the use of fine-needle aspiration (FNA) and fine-needle biopsy (FNB) consecutively. We explored the yield of combined use of 20 G FNB and 25 G FNA needles in patients with a suspicious solid gastrointestinal lesion. Patients from the ASPRO study who were sampled with both needles during the same procedure were included. The incremental yield of dual sampling compared with the yield of single needle use on the diagnostic accuracy for malignancy was assessed for both dual sampling approaches - FNA followed by FNB, and vice versa. 73 patients were included. There were 39 (53 %) pancreatic lesions, 18 (25 %) submucosal masses, and 16 (22 %) lymph nodes. FNA was used first in 24 patients (33 %) and FNB was used first in 49 (67 %). Generally, FNB was performed after FNA to collect tissue for ancillary testing (75 %), whereas FNA was used after FNB to allow for on-site pathological assessment (76 %). Diagnostic accuracy for malignancy of single needle use increased from 78 % to 92 % with dual sampling (P = 0.002). FNA followed by FNB improved the diagnostic accuracy for malignancy (P = 0.03), whereas FNB followed by FNA did not (P = 0.13). Dual sampling only improved diagnostic accuracy when 25 G FNA was followed by 20 G FNB and not vice versa. As the diagnostic benefit of the 20 G FNB over the 25 G FNA needle has recently been proven, sampling with the FNB needle seems a logical first choice.

Clinical Impact of EUS-Guided Fine Needle Biopsy Using a Novel Franseen Needle for Histological Assessment of Pancreatic Diseases.

Background and Aims Several studies have shown the benefits of endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) using a Franseen needle for histological assessment. However, studies focusing on pancreatic diseases are limited and the safety of this method has not been well assessed. We aimed to assess the current status and issues of EUS-FNB in the diagnosis of pancreatic diseases. Materials and Methods We retrospectively reviewed 87 consecutive EUS-FNB specimens using either a 22-gauge Franseen needle (Group A, N = 51) or a conventional 22-gauge fine-needle aspiration needle (Group B, N = 36) for pancreatic diseases, and the diagnostic accuracy and safety were compared. Final diagnoses were obtained based on surgical pathology or a minimum six-month clinical follow-up. Results Although the diagnostic accuracy for malignancy was 96.1% in Group A versus 88.9% in Group B, with no statistically significant difference (P = 0.19), the median sample area was significantly larger in Group A (4.07 versus 1.31mm2, P < 0.0001). There were no differences between the two needles in the locations from which the specimens were obtained. Adverse events occurred in one case (2%) in Group A (mild pancreatitis) and none in Group B with no statistical significance (P = 0.586). Although there was no case of bleeding defined as adverse events, 2 cases in Group A showed active bleeding during the procedure with increase in the echo-free space, which required CT scanning to rule out extravasation. Eventually, the bleeding stopped spontaneously. Conclusions Given its guaranteed ability to obtain core specimens and comparable safety, and although the risk of bleeding should be kept in mind, EUS-FNB using a Franseen needle is likely to become a standard procedure for obtaining pancreatic tissue in the near future.

A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device

Several studies have compared EUS-guided FNA with fine-needle biopsy (FNB), but none have proven superiority. We performed a multicenter randomized controlled trial to compare the performance of a commonly used 25-gauge FNA needle with a newly designed 20-gauge FNB needle. Consecutive patients with a solid lesion were randomized in this international multicenter study between a 25-gauge FNA (EchoTip Ultra) or a 20-gauge FNB needle (ProCore). The primary endpoint was diagnostic accuracy for malignancy and the Bethesda classification (non-diagnostic, benign, atypical, malignant). Technical success, safety, and sample quality were also assessed. Multivariable and supplementary analyses were performed to adjust for confounders. A total of 608 patients were allocated to FNA (n= 306) or FNB (n= 302); 312 pancreatic lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Technical success rate was 100% for the 25-gauge FNA and 99% for the 20-gauge FNB needle (P= .043), with no differences in adverse events. The 20-gauge FNB needle outperformed 25-gauge FNA in terms of histologic yield (77% vs 44%, P< .001), accuracy for malignancy (87% vs 78%, P= .002) and Bethesda classification (82% vs 72%, P= .002). This was robust when corrected for indication, lesion size, number of passes, and presence of an on-site pathologist (odds ratio, 3.53; 95% confidence interval, 1.55-8.56; P= .004), and did not differ among centers (P= .836). The 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histologic yield and diagnostic accuracy. This benefit was irrespective of the indication and was consistent among participating centers, supporting the general applicability of our findings. (Clinical trial registration number: NCT02167074.).

The diagnostic performance of 18F-FAMT PET and 18F-FDG PET for malignancy detection: a meta-analysis

This meta-analysis aims to compare the diagnostic performance of l-3-18F-α-methyl tyrosine (18F-FAMT) positron emission tomography (PET) and 2-deoxy-2-[18F]fluoro-d-glucose (18F-FDG) PET for malignancy detection. The workflow of this study follows Cochrane Collaboration Guidelines of a systematic review of diagnostic test accuracy studies. An electronic search was performed for clinical diagnostic studies directly comparing 18F-FAMT and 18F-FDG PET for malignant tumors. Study quality, the risks of bias and sources of variation among studies were assessed using the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) assessment tool. A separate meta-analysis was performed for diagnostic performance based on visual assessment and diagnostic cut-off values. Whenever possible, a bivariate random-effect model was used for analysis and pooling of diagnostic measures across studies. Electronic search revealed 56 peer-reviewed basic science investigations and clinical studies. Six eligible studies (272 patients) of various type of cancer were meta-analyzed. The 18F-FAMT diagnostic accuracy for malignancy was higher than 18F-FDG based on both visual assessment (diagnostic odd ratio (DOR): 8.90, 95% confidence interval (CI) [2.4, 32.5]) vs 4.63, 95% CI [1.8, 12.2], area under curve (AUC): 77.4% vs 72.8%) and diagnostic cut-off (DOR: 13.83, 95% CI [6.3, 30.6] vs 7.85, 95% CI [3.7, 16.8], AUC: 85.6% vs 80.2%), respectively. While the average sensitivity and specificity of 18F-FAMT and 18F-FDG based on visual assessment were similar, 18F-FAMT was significantly more specific than 18F-FDG (p < 0.05) based on diagnostic cut-off values. 18F-FAMT is more specific for malignancy than 18F-FDG, while their sensitivity is comparable. 18F-FAMT PET is equal to 18F-FDG PET in diagnostic performance for malignancy detection in several cancer types.

Diagnostic accuracy of haptoglobin within ovarian cyst fluid as a potential point-of-care test for epithelial ovarian cancer: an observational study.

To investigate haptoglobin within ovarian cyst fluid (OCF) as a diagnostic biomarker for epithelial ovarian cancer (EOC) and develop an invitro diagnostic point-of-care device test (IVDPCT) for use in the operating theatre. Retrospective and prospective cohort study. South-East Asia. Women with suspicious ovarian cysts. Proteomic, immunohistochemical and ELISA methods measured haptoglobin in OCF to differentiate benign and EOCs. Diagnostic performance of haptoglobin was compared with CA125, risk malignancy indices (RMI) and frozen section. Blinded validation of the IVDPCT was performed. Prediction of malignancy. Haptoglobin concentration measured by ELISA was 0.70±0.09mg/ml in patients with benign cysts (n=87), 6.22±0.53mg/ml in early stage-EOC (n=17), and 6.57±0.65mg/ml in late stage-EOC (n=20). Haptoglobin in EOCs was significantly higher than in benign cysts (P<0.0001). Haptoglobin using rapid colorimetric assay (RCA) on a training set had a sensitivity of 97.3% and a specificity 92.0%, comparable to ELISA and frozen sections. The haptoglobin AUROC curve was 0.999 (95% CI 0.997-1.000) compared with 0.895 (95% CI 0.814-0.977, P<0.05) for CA125. Haptoglobin performed significantly better than all the RMIs (P<0.01). Blinded validation studies showed a minor drop in average diagnostic performance (sensitivity 85.2% and specificity 90.5%) compared with the training set. However, when compared with frozen section, haptoglobin was no worse in diagnostic accuracy for malignancy. Haptoglobin was identified as a biomarker for the detection of EOC with potential as a point-of-care diagnostic tool. Haptoglobin within ovarian cyst fluid: a biomarker for epithelial ovarian cancer and point-of-care diagnostics.

Utility of touch imprint cytology as an adjunct to core needle biopsy of breast lump

Background: Touch imprint cytology is an easy and rapid method of evaluation of cancers. It can be utilized as a rapid intraoperative method and on site evaluation of biopsy specimen. Aim: to evaluate the efficacy of touch imprint cytology in assessment of adequacy of needle core biopsy of breast lumps its diagnostic accuracy for malignancy. Material and methods: A total of 160 cases of core needle biopsies of breast lump were studied. In each case touch imprint were made and a cytological diagnosis was offered on site. The results were correlated with the final biopsy diagnosis. Results: Adequate and satisfactory material on touch imprint was obtained in 154 (96.3%) cases.A total of 132 (82.5 %) cases were diagnosed as malignant and 21 (13.1 %) cases were diagnosed as benign on touch imprint cytology. Three cases (1.9%) were inconclusive, as the cells were obscured with inflammatory cells or there were crush artefacts. Overall sensitivity of TIC was 98.3 %, specificity was 70.3 %, positive predictive value was 93.8 %, negative predictive value was 90.4 % and accuracy was 90.2%. In 135 (88.2%) cases, a specific diagnosis regarding the exact histological subtype of the breast lesion could be provided. Conclusions: Touch imprint cytology of core needle biopsy specimens of breast lump yields adequate and satisfactory diagnostic material. It can be used routinely at the site of biopsy to evaluate the adequacy of material obtained during core needle biopsy. Touch imprints gives rapid and fairly accurate diagnosis of malignancy and subtyping of tumor is also possible. Key words: breast lump, core needle biopsy, touch imprint cytology, accuracy

Systematic Review With Meta-analysis: Prompt Endoscopy As the Initial Management Strategy for Uninvestigated Dyspepsia in Asi (Aliment Pharmacol Ther 2015;41:239-252).

Dyspepsia is a common gastrointestinal (GI) symptom with 10–20% of the population in the Asia-Pacific region.1 In Western countries, 40–60% of individuals have a normal examination, whilst esophageal or gastric malignancies are detected in less than 1%.2 In Asia, the prevalence of Helicobacter pylori infection and upper GI malignancies are substantially high.3,4 However, among Asian patients with uninvestigated dyspepsia, the diagnostic value of alarm features and the appropriateness of prompt endoscopy are remained uncertainly. Chen et al5 performed a systematic review to evaluate the detection rate of organic diseases including upper GI malignancies and then to propose the proper initial diagnostic strategy in Asian dyspepsia patients. Among 2410 possible references, finally 18 papers (n = 152 314) were included in the analysis of detection of organic disease by endoscopy among dyspeptic patients. This study revealed that overall malignancy detection rate was 1.3% (95% confidence interval 0.8–2.1%) and among cancer patients, 17.8% were younger than 45 years, 5.0% at age < 40 years and 3.0% at age < 35 years. The calculated detection rate of all organic diseases was 26.4% and that of peptic ulcer disease was 11.9% and esophageal disease was 5.5%. However, alarm features were shown to yield moderate diagnostic accuracy with an area under curve of 0.74. It meant limited accuracy for predicting malignancy. Therefore, authors concluded that an age of 35 years yielded relatively better diagnostic accuracy for malignancy.

Usefulness of endoscopic ultrasound-guided sampling using core biopsy needle as a percutaneous biopsy rescue for diagnosis of solid liver mass: Combined histological-cytological analysis.

Endoscopic ultrasound (EUS)-guided fine needle aspiration (EUS-FNA) is one of the alternative methods for tissue sampling of liver solid mass. However, the diagnostic efficacy using cytology alone was limited. In this study, we evaluate the diagnostic accuracy of EUS-guided fine needle biopsy (EUS-FNB) as a percutaneous biopsy rescue for liver solid mass. The EUS-FNB using core biopsy needle for liver solid mass was performed prospectively for patients who were failure to acquire a tissue or achieve a diagnosis using percutaneous liver biopsy. The primary outcome was the diagnostic accuracy of EUS-FNB for malignancy and specific tumor type. The secondary outcomes were the median numbers of passes required to establish a diagnosis, the proportions of patients in whom immunohistochemical (IHC) stain was possible and obtained adequate specimen, and safety of EUS-FNB. Twenty-one patients (12 women; mean age, 63 years [range, 37-81]) underwent EUS-FNB for solid liver masses. The median number of needle passes was 2.0 (range, 1-5). On-site cytology and cytology with Papanicolaou stain showed malignancy in 16 patients (76.2%) and 17 patients (81.0%), respectively. In histology with HE stain, 19 patients (90.5%) were diagnosed malignancy and optimal to IHC stain. The overall diagnostic accuracy for malignancy and specific tumor type were 90.5% and 85.7%, respectively. No complications were seen. EUS-FNB with core biopsy needle for solid liver mass may be helpful in the management of patients who are unable to diagnose using percutaneous liver biopsy.

Clinicopathological Meaning of Size of Main-Duct Dilatation in Intraductal Papillary Mucinous Neoplasm of Pancreas: Proposal of a Simplified Morphological Classification Based on the Investigation on the Size of Main Pancreatic Duct.

The 2012 consensus guideline on intraductal papillary mucinous neoplasm of the pancreas (IPMN) described a three-stage criteria involving main pancreatic duct (MPD) size with definitions of malignancy relevant for treatment decisions. Re-evaluation and simplification of this classification for clinicians are warranted. Data from the Seoul National University Hospital of 375 consecutive patients with pathology-confirmed IPMN after surgery were analyzed. The association between clinicopathologic characteristics of IPMN and MPD size was assessed. The cut-off value of MPD size for a current definition of malignancy prediction was calculated. Diagnostic accuracy for malignancy was highest when the cut-off value of MPD size was 7 mm (area under the curve=0.7126). Dichotomizing IPMN into MPD≤7 mm versus MPD> mm, patient age (p=0.039), sex (p=0.001), presence of mural nodule (p<0.001), and invasiveness risk (13.2 vs. 39.8%, p<0.001) resulted in significantly different results. Mural nodule-negative patients with MPD>7 mm had a significantly lower 5-year survival rate than those with MPD≤7 mm (78.4 vs. 91.4%, p=0.006). Among patients with MPD size≤7 mm, elevated serum CA 19-9 and mural nodule were independent risk factors of malignancy. Patients with MPD size≤7 mm without these risk factors had malignancy risk of 2.6%. Using the definition of malignancy provided in the 2012 guideline, the MPD size> mm criterion was statistically driven. The current morphologic classification of IPMN can be simplified as branch-duct-predominant IPMN (MPD≤7 mm)' and main-duct-predominant IPMN (MPD> mm). Patients who are determined to have main-duct-predominant IPMN and branch-duct-predominant IPMN with elevated serum CA 19-9 or mural nodule are recommended to undergo surgical treatment.

Time sensitivity-corrected retention index: an enhanced metabolic index from 18F-FDG PET to differentiate between benign and malignant pulmonary nodules.

The aim of the study was to evaluate pulmonary nodules (PNs) by incorporating time sensitivity (S) factor in the retention index (RI) and compare with the traditional fixed interval method. After obtaining approval from the Human Investigations Committee, 97 PNs from 81 patients (age=70±11) referred for dual-time fluorine-18 fluorodeoxyglucose PET (16.1±1.9 mCi) with definite pathological diagnosis or 1-year computed tomography follow-up were retrospectively studied. S=d{ln[SUV]]/d{ln[T]} was obtained by logarithmic regression using scan times, T (0, 1, 2), and standard uptake value (SUV) (0, 1, 2). This time-corrected RI, RIs=[(T2/T1)-1]×100%, was compared with traditional fixed time interval RI, RIx=[(SUV2/SUV1)-1]×100%, by means of receiver operating characteristic curve analysis. The mean±SD of T1 and T2 (72.3±14.0 and 134.9±17.6 min, respectively) skewed markedly from the intended time of PET scans (skewness=2.076 and 1.356, respectively). There were 27 benign tumors, 37 cases of non-small-cell lung cancer, 15 other types of cancer, and 18 stable lesions by 1-year computed tomography follow-up. There were significant differences between the nonmalignant group (NM, n=45) and the cancer group (CA, n=52) in time sensitivity (0.186±0.161 vs. 0.483±0.180, P<0.0005) and RIs (12.7±12.5 vs. 37.4±17.5%, P<0.0005). The RIx showed wider variation than RIs, although the difference between NM and CA was also significant (18.0±28.8 vs. 37.8±32.0%, P=0.002). The RIs and RIx were only weakly correlated (r=0.257, P=0.011). Receiver operating characteristic curve analysis performed for the CA or NM groups revealed a significant improvement in the diagnostic accuracy for malignancy by RIs (area under the curve=0.880±0.035, P<0.0005) compared with RIx (area under the curve=0.694±0.054, P=0.001). Incorporating the time sensitivity factor improves the diagnostic performance of RI for malignant PNs by using additional biologic information from the variation in fluorine-18 fluorodeoxyglucose uptake times and rates.

Core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study.

An endoscopic ultrasound (EUS)-guided fine needle biopsy (EUS-FNB) device using a core biopsy needle was developed to improve diagnostic accuracy by simultaneously obtaining cytological aspirates and histological core samples. We prospectively compared the diagnostic accuracy of EUS-FNB with standard EUS-guided fine needle aspiration (EUS-FNA) in patients with solid pancreatic masses. Between January 2012 and May 2013, consecutive patients with solid pancreatic masses were prospectively enrolled and randomized to undergo EUS-FNB using a core biopsy needle or EUS-FNA using a standard aspiration needle at a single tertiary center. The specimen was analyzed by onsite cytology, Papanicolaou-stain cytology, and histology. The main outcome measure was diagnostic accuracy for malignancy. The secondary outcome measures were: the median number of passes required to establish a diagnosis, the proportion of patients in whom the diagnosis was established with each pass, and complication rates. The overall accuracy of combining onsite cytology with Papanicolaou-stain cytology and histology was not significantly different for the FNB (n = 58) and FNA (n = 58) groups (98.3 % [95 %CI 94.9 % - 100 %] vs. 94.8 % [95 %CI 91.9 % - 100 %]; P = 0.671). Compared with FNA, FNB required a significantly lower median number of needle passes to establish a diagnosis (1.0 vs. 2.0; P < 0.001). On subgroup analysis of 111 patients with malignant lesions, the proportion of patients in whom malignancy was diagnosed on the first pass was significantly greater in the FNB group (72.7 % vs. 37.5 %; P < 0.001). The overall accuracy of FNB and FNA in patients with solid pancreatic masses was comparable; however, fewer passes were required to establish the diagnosis of malignancy using FNB.This study was registered on the UMIN Clinical Trial Registry (UMIN000014057).

Risk prediction model of malignant partially cystic thyroid nodules

Objective A multivariate logistic regression model was built to estimate the risk of malignant partially cystic thyroid nodules.Methods Data of ultrasonographic morphology,microcalcifications,margin,colloid crystals and echogenicity of 766 thyroid nodules (of 506 patients) were analyzed retrospectively.All patients underwent surgery and the diagnosis were confirmed by pathology.The model was built to calculate the individual risk and evaluate the predictive index.Results The regression model was Z =-2.30 + 1.42X2 + 2.39X3 + 1.17X4-1.35 X7 + 0.62X9 ; P =eZ/1 + ez (P represents probability of malignancy,e represents natural constant 2.72).The largest area under the receiver-operating characteristics curve (AUC) was 0.86.When apply the model to the verification group(266 nodules),the accuracy,sensitivity,specificity,misdiagnosis rate,missed diagnosis rate,negative likelihood ratio and positive likelihood ratio were 93.61％,83.33％,94.63％,5.37％,16.67％、0.18 and 15.52 respectively.Conclusions This model based on the ultrasonographic variables increases the diagnostic accuracy of malignancy in patients with partially cystic thyroid nodules. Key words: Ultrasonography; Thyroid nodule; Logistic models

Diagnostic Accuracy for Malignancy in Open Surgical Biopsy of Neck Lymph Nodes

Received June 13, 2014 Revised July 18, 2014 Accepted August 11, 2014 Address for correspondence Han-Sin Jeong, MD, PhD Department of OtorhinolaryngologyHead and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 135-710, Korea Tel +82-2-3410-3579 Fax +82-2-3410-3879 E-mail hansin.jeong@gmail.com Background and ObjectivesZZThe open surgical biopsy (OSB) of neck lymph nodes is considered a definite diagnostic procedure; however, the diagnostic accuracy of this procedure has not been fully studied. Thus, we aimed to identify the false negative rates of OSB for malignancy and the possible causes of misdiagnosis that might severely affect patient prognosis. Subjects and MethodZZWe extracted the data from 495 OSB of neck lymph nodes between 2005 and 2012. The diagnostic accuracy of OSB of neck lymph nodes was estimated based on rebiopsy. In addition, we reviewed possible clinical factors related to false negativity, cause of misdiagnosis and its clinical impacts. ResultsZZThe false negative rate of OSB of neck nodes was 2.2% with a risk of 3.8% false diagnosis among subjects with initial ‘benign’ results. The cases of the initial misdiagnosis (n=7) had the dismal outcomes (4 deaths, 1 disease progression). The main cause of misdiagnosis was the failure to target the disease-affected lymph nodes (85.7%). Malignancy-related symptoms persisted in all cases of misdiagnosis, which required re-biopsy. ConclusionZZAccurate targeting of lymph nodes, close monitoring of clinical symptoms and comparison of biopsy results with symptoms are very important to reduce false negativity for malignancy in OSB of neck lymph nodes. Korean J Otorhinolaryngol-Head Neck Surg 2014;57(12):841-6