Usefulness of a target sample check illuminator in the detection of target specimens in endoscopic ultrasound-guided fine-needle biopsy samples: Multicenter prospective study

Kazuya Matsumoto; Kazuo Hara; Ichiro Yasuda; Takao Itoi; Hiroki Kurumi; Shimpei Matsumoto; Shinpei Doi; Mitsuyoshi Honjo; Yohei Takeda; Jin Shibuya; Hisashi Noma; Hajime Isomoto

doi:10.1111/den.13903

Usefulness of a target sample check illuminator in the detection of target specimens in endoscopic ultrasound-guided fine-needle biopsy samples: Multicenter prospective study

Dig Endosc. 2021 Sep;33(6):970-976. doi: 10.1111/den.13903. Epub 2020 Dec 28.

Authors

Kazuya Matsumoto^{1

2}, Kazuo Hara³, Ichiro Yasuda^{4

5}, Takao Itoi⁶, Hiroki Kurumi¹, Shimpei Matsumoto³, Shinpei Doi⁵, Mitsuyoshi Honjo⁶, Yohei Takeda¹, Jin Shibuya³, Hisashi Noma⁷, Hajime Isomoto¹

Affiliations

¹ Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori, Japan.
² Irisawa Medical Clinic, Shimane, Japan.
³ Department of Gastroenterology, Aichi Cancer Center Hospital, Aichi, Japan.
⁴ Third Department of Internal Medicine, Graduate School of Medicine, University of Toyama, Toyama, Japan.
⁵ Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa, Japan.
⁶ Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.
⁷ Department of Data Science, The Institute of Statistical Mathematics, Tokyo, Japan.

PMID: 33251622
DOI: 10.1111/den.13903

Abstract

Objectives: Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) uses a thin needle, rendering unclear whether the collected sample contains pathological evidence. We examined the usefulness of our target sample check illuminator (TSCI) through a multicenter prospective trial.

Methods: We included 52 consecutive patients. After assessing EUS-FNB samples by conventional (visual observation) and TSCI methods, we evaluated consistency with the histopathological diagnosis. We compared the target sample confirmation rate between conventional and TSCI methods and evaluated the diagnostic ability separately.

Results: Comparison between the conventional and TSCI methods revealed the following: (i) for all cases: sensitivity, 51.0% (25/49) vs. 95.9% (47/49) (P = 0.001); specificity, 100% (3/3) vs. 66.7% (2/3); positive predictive value (PPV), 100% (25/25) vs. 97.9% (47/48); and negative predictive value (NPV), 11.1% (3/27) vs. 50.0% (2/4) (P = 0.002); (ii) for pancreatic masses: sensitivity, 28.0% (7/25) vs. 96.0% (24/25) (P < 0.001); specificity, 100% (2/2) vs. 100% (2/2); PPV, 100% (7/7) vs. 100% (24/24); and NPV, 10.0% (2/20) vs. 66.7% (2/3) (P < 0.001) (the TSCI method showed significantly better sensitivity and NPV than the conventional method); and (iii) for lymph node tumors: sensitivity, 75.0% (18/24) vs. 95.8% (23/24) (P = 0.025); specificity, 100% (1/1) vs. 0% (0/1); PPV, 100% (18/18) vs. 95.8% (23/24); and NPV, 14.3% (1/7) vs. 0% (0/1).

Conclusions: The TSCI improved the sensitivity, NPV, and accuracy of target sample confirmation for pancreatic mass EUS-FNB. Although the proportion of samples not including a target region was quite low, which could strongly influence our results, the TSCI method can be used in EUS-FNB when rapid on-site evaluation cannot be performed. (A multicenter prospective study for the utility of a target sample check illuminator, Clinical Trial ID: UMIN000023349).

Keywords: endoscopic ultrasound-guided fine-needle aspiration; endoscopic ultrasound-guided fine-needle biopsy; pancreatic masses and lymph node tumors; rapid on-site evaluation; target sample check illuminator.

Publication types

Multicenter Study

MeSH terms

Endoscopic Ultrasound-Guided Fine Needle Aspiration*
Humans
Image-Guided Biopsy
Needles
Pancreatic Neoplasms* / diagnostic imaging
Prospective Studies