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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)To read this article in full you will need to make a payment
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Article info
Publication history
Accepted:
January 17,
2023
Received in revised form:
January 5,
2023
Received:
September 9,
2022
Publication stage
In Press Journal Pre-ProofFootnotes
Authors’ contributions
Conceptualization, KT, IY; methodology, KT and IY; software, KT; validation, KT, IY, and KN; formal analysis, KT, IY; investigation, KT; resources, KT, NH, TI, MO, TM, MM, SA, SD, JI, EO and HM; data curation, KT; writing—original draft preparation, KT; writing—review and editing, IY, TI, MO, TM, MM, SA, SD, EO and KN; visualization, KT; supervision, IY and KN; project administration, IY
All authors have read and agreed to the published version of the manuscript.
Conflict of interest
The authors declare no conflict of interest.
Funding Sources
None.
Clinical trial registration
The study was registered at the University Hospital Medical Information Network Trials Registry (UMIN000037309).
Key words: Pancreatic neoplasms, endoscopic ultrasound-guided fine-needle aspiration, pancreas, macroscopically visible core
Identification
Copyright
© 2023 by the American Society for Gastrointestinal Endoscopy
