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A 19-Gauge Histology Needle Versus a 19-Gauge Standard Needle in Endoscopic Ultrasound-Guided Fine-Needle Aspiration for Solid Lesions: A Multicenter Randomized Comparison Study (GREATER Study)

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Abstract

Background

The necessity of histological analysis is increasing. A 19-gauge histology needle (PC19) in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has recently been developed and has shown high yields of tissue acquisition and histological diagnosis.

Aims

To compare the histological diagnostic yield in single-pass EUS-FNA for solid lesions using PC19 and a standard 19-gauge needle (EC19).

Patients and Methods

Consecutive patients with solid lesions were enrolled and underwent one pass with each of PC19 and EC19 for EUS-FNA with the randomized order of the needles. The primary endpoint was the histological diagnostic accuracy. The secondary endpoints were the feasibility, yield of histological core, cytological and overall diagnostic accuracies, and adverse events. Subgroup analysis was performed for the optimal situation with PC19.

Results

Of the 115 patients, 110 underwent EUS-FNA and five were excluded. EUS-FNA was performed from the esophagus in four, stomach in 80, or duodenum in 26. The final diagnosis was malignancy in 100 and benign in 10. The feasibility was 98.2 and 97.3% with PC19 and EC19, respectively (p = 1.00). The rate of presence of a histological core and the histological, cytological, and overall diagnostic accuracies for PC19 versus EC19 were 84.6 versus 80.9% (p = 0.593), 83.6 versus 73.6% (p = 0.099), 63.6 versus 56.4% (p = 0.335), and 90.0 versus 79.1% (p = 0.039), respectively. PC19 was favored in the trans-esophageal/gastric approaches to obtain a histological diagnosis (p = 0.013). Adverse events were observed in four patients.

Conclusion

Single-pass EUS-FNA with PC19 was feasible and showed significantly higher overall diagnostic accuracy and an increased tendency towards histological diagnostic accuracy, especially with trans-esophageal/gastric FNA.

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Abbreviations

EUS-FNA:

Endoscopic ultrasound-guided fine needle aspiration

PC19:

A 19-gauge histology needle

EC19:

A standard 19-gauge needle

PT-INR:

Prothrombin time-international normalized ratio

PS:

Eastern Cooperative Oncology Group performance status

ASGE:

The American Society for Gastrointestinal Endoscopy

IQR:

The interquartile range

95% CI:

95% Confidence interval

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Authors and Affiliations

  1. First Department of Internal Medicine, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan

    Takuji Iwashita

  2. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

    Yousuke Nakai & Hiroyuki Isayama

  3. Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan

    Tsuyoshi Mukai

  4. Department of Gastroenterology, Kanto Central Hospital, Tokyo, Japan

    Osamu Togawa

  5. Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan

    Saburo Matsubara

  6. Department of Tumor Pathology, Gifu University Graduate School of Medicine, Gifu, Japan

    Yuichiro Hatano & Akira Hara

  7. Department of Pathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

    Mariko Tanaka & Masashi Fukayama

  8. Department of Pathology, Kyorin University Faculty of Medicine, Tokyo, Japan

    Junji Shibahara

  9. Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan

    Ichiro Yasuda

Authors
  1. Takuji Iwashita
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  2. Yousuke Nakai
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  7. Akira Hara
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Contributions

TI wrote the manuscript. TI, YN, TM, OT, SM, IY, and HI managed the patients. YH, AH, MT, JS and MF performed pathological evaluation. TI is corresponding author of this paper.

Corresponding author

Correspondence to Takuji Iwashita.

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Conflict of interest

Takuji Iwashita, Yousuke Nakai, Tsuyoshi Mukai, Osamu Togawa, Saburo Matsubara, Yuichiro Hatano, Akira Hara, Mariko Tanaka, Junji Shibahara, Masashi Fukayama, Hiroyuki Isayama, and Ichiro Yasuda have nothing to declare.

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Iwashita, T., Nakai, Y., Mukai, T. et al. A 19-Gauge Histology Needle Versus a 19-Gauge Standard Needle in Endoscopic Ultrasound-Guided Fine-Needle Aspiration for Solid Lesions: A Multicenter Randomized Comparison Study (GREATER Study). Dig Dis Sci 63, 1043–1051 (2018). https://doi.org/10.1007/s10620-018-4913-y

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  • DOI: https://doi.org/10.1007/s10620-018-4913-y

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