Reverse-Bevel (ProCore) EUS-Guided Fine-Needle Biopsy for Solid Pancreatic Mass Lesions: a GRADE-Assessed Systematic Review and Meta-Analysis of Prospective Randomized Trials.
Endoscopic ultrasound-guided tissue acquisition is used to diagnose pancreatic mass lesions, but optimal needle selection remains uncertain. Reverse bevel ProCore fine needle biopsy (FNB) needles aim to enhance histologic procurement and reduce sampling burden; randomized evidence versus standard fine needle aspiration (FNA) is limited. We synthesized randomized trials to compare diagnostic performance, efficiency, and safety.
We searched MEDLINE (PubMed), Embase, Cochrane CENTRAL, Scopus, Web of Science, and ClinicalTrials.gov for randomized trials (parallel or crossover) comparing reverse bevel ProCore FNB with standard FNA in pancreatic masses. The primary outcome was diagnostic yield. Secondary outcomes included sensitivity, specificity, number of passes, sample adequacy, technical failure, and complications. Random effects meta-analysis pooled risk ratios and mean differences with 95% confidence intervals. Heterogeneity was assessed using I²; leave-one-out analyses explored high heterogeneity. Certainty of evidence was assessed with GRADE.
Five randomized trials (412 patients) were included. Diagnostic yield was equivalent (RR 0.99, 95% CI 0.94-1.05; I²=55%). Sensitivity (RR 1.03, 95% CI 0.96-1.11) and specificity (RR 1.05, 95% CI 0.87-1.27) were similar. ProCore required fewer passes (MD - 0.69, 95% CI - 1.11 to - 0.27; I²=79%). Sample adequacy was comparable (RR 1.02, 95% CI 0.90-1.16; I²=66%). Complications were uncommon (RR 1.93, 95% CI 0.57-6.58; I²=0%). Trial design did not modify diagnostic yield.
Reverse bevel ProCore FNB provides diagnostic yield comparable to standard FNA while reducing needle passes. Low to very low certainty supports individualized needle choice based on resources and tissue requirements.
We searched MEDLINE (PubMed), Embase, Cochrane CENTRAL, Scopus, Web of Science, and ClinicalTrials.gov for randomized trials (parallel or crossover) comparing reverse bevel ProCore FNB with standard FNA in pancreatic masses. The primary outcome was diagnostic yield. Secondary outcomes included sensitivity, specificity, number of passes, sample adequacy, technical failure, and complications. Random effects meta-analysis pooled risk ratios and mean differences with 95% confidence intervals. Heterogeneity was assessed using I²; leave-one-out analyses explored high heterogeneity. Certainty of evidence was assessed with GRADE.
Five randomized trials (412 patients) were included. Diagnostic yield was equivalent (RR 0.99, 95% CI 0.94-1.05; I²=55%). Sensitivity (RR 1.03, 95% CI 0.96-1.11) and specificity (RR 1.05, 95% CI 0.87-1.27) were similar. ProCore required fewer passes (MD - 0.69, 95% CI - 1.11 to - 0.27; I²=79%). Sample adequacy was comparable (RR 1.02, 95% CI 0.90-1.16; I²=66%). Complications were uncommon (RR 1.93, 95% CI 0.57-6.58; I²=0%). Trial design did not modify diagnostic yield.
Reverse bevel ProCore FNB provides diagnostic yield comparable to standard FNA while reducing needle passes. Low to very low certainty supports individualized needle choice based on resources and tissue requirements.
Authors
Mirza Mirza, Badshah Badshah, Gastroenterologist Gastroenterologist, Hadhoud Hadhoud, Moeen-Ud-Din Moeen-Ud-Din, Imtiaz Imtiaz
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