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Endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic tumors with 3 versus 12 to-and-fro movements: A multicenter prospective randomized controlled study

Published:January 23, 2023DOI:https://doi.org/10.1016/j.gie.2023.01.037
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      ABSTRACT

      Background and Aims

      A novel endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) needle enabled physicians to obtain sufficient pathological samples with fewer to-and-fro movements within the lesion. We compared the diagnostic yields of EUS-FNB with 3- and 12-to-and-fro movements (3-TAFs and 12-TAFs) at each puncture pass.

      Methods

      The primary endpoint of this multicenter, non-inferiority, crossover, randomized controlled trial involving six centers was diagnostic sensitivity. Secondary endpoints included diagnostic accuracy and quantity and quality evaluation of EUS-FNB samples. Length of the macroscopically visible core (MVC) and microscopic histological quantity were used for quantitative evaluation. Macroscopic visual and microscopic histological evaluations were performed for qualitative evaluation.

      Results

      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: -0.9%; 95% confidence interval: -9.81–7.86). Diagnostic accuracy for malignancy was 92.7% and 94.6% for 3-TAFs and 12-TAFs, respectively. Overall median MVC length was 13.5 mm in both groups. The 3-TAFs group had a significantly higher rate of score ≥3 on macroscopic visual quality evaluation than the 12-TAFs group (71.8% vs. 52.7%, p=0.009). No significant inter-group differences existed in microscopic histological quantity and quality evaluations (quantity evaluation: 3-TAFs 88.2% vs. 12-TAFs 83.6%; quality evaluation: 3-TAFs 90.0% vs. 12-TAFs 89.1%).

      Conclusions

      Diagnostic sensitivity and accuracy of EUS-FNB with 3-TAFs were not inferior to those with 12-TAFs for solid pancreatic lesions. The 3-TAFs group showed significantly less blood contamination in sampled tissues than the 12-TAFs group.

      Abbreviations:

      CI (confidence interval), CT (computed tomography), EUS (Endoscopic ultrasonography), EUS-FNA (endoscopic ultrasound-guided fine-needle aspiration), EUS-FNB (endoscopic ultrasound-guided fine-needle biopsy), GKH (Gihoku Kosei Hospital), GMH (Gifu Municipal Hospital), GUH (Gifu University Hospital), MOSE (Macroscopic on-site evaluation of biopsy specimens), MRI (magnetic resonance imaging), MVC (macroscopically visible core), NUH (Nagasaki University Hospital), PET (positron emission tomography), RCT (randomized controlled trial), TAF (to-and-fro movement), TUH (Toyama University Hospital), TUMH (Teikyo University Mizonokuchi Hospital)
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