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Background and Aims: 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., Methods: 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., Results: 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)., Conclusion: 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.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: EUS-guided FNA is an efficacious technique for sampling intraintestinal and extraintestinal mass lesions. However, cytology has limitations to its final yield and accuracy, which may be overcome if histological specimens are provided to the pathologist., Objective: To evaluate feasibility, yield, and diagnostic accuracy of a newly developed 19-gauge, fine-needle biopsy (FNB) device., Design: Multicenter, pooled, cohort study., Setting: Five medical centers., Patients: This study involved 109 consecutive patients with 114 intraintestinal or extraintestinal mass lesions and/or peri-intestinal lymph nodes., Intervention: EUS-guided FNB (EUS-FNB) with a newly developed, 19-gauge, FNB device., Main Outcome Measurements: Percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation and the overall diagnostic accuracy compared with a composite criterion-standard diagnosis., Results: We evaluated 114 lesions (mean [± standard deviation] size 35.1 ± 18.7 mm; 84 malignant [73.7%] and 30 [26.3%] benign). EUS-FNB was technically feasible in 112 lesions (98.24%). Sample quality was adequate for full histological assessment in 102 lesions (89.47%). In 98 cases (85.96%), diagnosis proved to be correct according to criterion-standard diagnosis. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy for diagnosis of malignancy were 90.2%, 100%, 100%, 78.9%, and 92.9%, respectively., Limitations: Use of a surrogate criterion-standard diagnosis, including clinical follow-up when no surgical specimens were available, mainly in benign diagnoses., Conclusion: Performing an EUS-FNB with a new 19-gauge histology needle is feasible for histopathology diagnosis of intraintestinal and extraintestinal mass lesions, offering the possibility of obtaining a core sample for histological evaluation in the majority of cases, with an overall diagnostic accuracy of over 85%., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Pancreatic endocrine tumors (PETs) differ in clinical behavior and prognosis. Determination of malignant potential through specimens obtained by EUS-FNA can help in the management of these patients., Objective: To determine the value of EUS-FNA for diagnosing PETs and for classifying their underlying malignant potential based on the World Health Organization (WHO) classification., Design: Single-center, retrospective, cohort study., Setting: Tertiary referral hospital., Patients: This study involved 86 consecutive patients (44 men, mean age 58 +/- 14 years) who had been diagnosed with PETs and submitted to EUS-FNA from January 1999 to August 2008., Intervention: EUS-FNA of a pancreatic mass and/or a metastasis site. Immunohistochemistry on microbiopsies or on monolayer cytology was routinely used. The lesions were classified as recommended by the WHO., Main Outcome Measurements: EUS-FNA sensitivity and 5-year survival rate., Results: Overall, in 90% (77 of 86) of patients in this study, PET was diagnosed with EUS-FNA. The sensitivity did not vary with tumor size, type, location, or the presence of hormonal secretion. Of 86 patients, 30 (35%) were submitted to surgical resection. The kappa correlation index between the WHO classification obtained by EUS-FNA and by surgery was 0.38 (P = .003). Major discrepancies were found in the group of patients diagnosed with endocrine tumor of uncertain behavior by EUS-FNA, because 72% turned out to have well-differentiated endocrine carcinoma. Sixteen patients (27%) died during a mean follow-up period of 34 +/- 27 months. The 5-year survival rates were 100% for endocrine tumors, 68% for well-differentiated endocrine carcinomas, and 30% for poorly differentiated endocrine carcinomas (P = .008, log-rank test)., Limitations: Retrospective design, selection bias, and small sample size., Conclusions: This largest single-center experience to date demonstrated the accuracy of EUS-FNA in diagnosing and determining the malignant behavior of PETs. EUS-FNA findings predict 5-year survival in patients with PETs.

Background: EUS-guided pancreatogastrostomy (EPG) is described as an alternative to surgery for ductal decompression in symptomatic patients when endoscopic transpapillary access of the main pancreatic duct (MPD) is impossible., Objective: To present the midterm clinical response and follow-up of a larger group of patients treated with EPG and a new transbulbar approach, EUS-guided pancreatobulbostomy (EPB)., Design: Retrospective case review., Setting: Two tertiary referral centers in Brussels and Marseille., Patients: From 2000 to 2004, 36 patients (51 years old; range, 14-71 years) were seen., Intervention: EPG or EPB., Main Outcome Measurements: Pain relief, technical aspects, complications, and clinical follow-up., Results: Indications were chronic pancreatitis, with complete obstruction (secondary to a tight stenosis, a stone, or MPD rupture); inaccessible papilla or impossible cannulation (n = 20); anastomotic stenosis after a Whipple procedure (n = 12); complete MPD rupture after acute pancreatitis (AP); or trauma (n = 4). EPG or EPB was unsuccessful in 3 patients; 1 was lost to follow-up. Major complications occurred in 2 patients and included 1 hematoma and 1 severe AP. The median follow-up was 14.5 months (range, 4-55 months). Pain relief was complete or partial in 25 patients (69%, intention to treat). Eight patients treated had no improvement of their symptoms (4 were subsequently diagnosed with cancer). Stent dysfunction occurred in 20 patients (55%) and required a total of 29 repeat endoscopies., Limitations: Technically demanding and requires careful pretherapeutic evaluation., Conclusions: EPG or EPB appears to be an effective and relatively safe treatment for the management of pain secondary to pancreatic ductal hypertension in patients with an MPD not accessible by a transpapillary route.