Abstract
Background
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) was developed with the aim of further improving the diagnostic performance of endoscopic ultrasound. Although novel puncture needles have been specifically designed for collecting sufficient tissue specimens, clinical studies have indicated no clear difference in diagnostic performance between these novel needles and conventional puncture needles. Recently, a needle with Franseen geometry was developed specifically for EUS-FNA biopsy. Due to the characteristic shape of its tip, the Franseen needle is expected to be effective for scraping tissues, thus potentially increasing the diagnostic accuracy of EUS-FNA biopsy. We plan to carry out a prospective, multicenter, open-labeled, controlled trial to compare conventional and Franseen needles in terms of the diagnostic accuracy of EUS-FNA for evaluating the malignancy of pancreatic mass lesions.
Methods/design
The study will enroll 520 patients with pancreatic mass managed at any of 21 participating endoscopic centers. Lesion samples obtained using 22G conventional and Franseen needles will be assessed to compare the efficacy and safety of these two types of needles in EUS-FNA for evaluating the malignancy of mass lesions in the pancreas. Tissue samples will be fixed in formalin and processed for histologic evaluation. For the purpose of this study, only samples obtained with the first needle pass will be used for comparing the: (i) accuracy of the malignancy diagnosis, (ii) sensitivity and specificity for the malignancy diagnosis, (iii) procedure completion rate, (iv) sample cellularity, and (v) incidence of complications. Patient enrollment begins on July 17, 2018.
Discussion
The outcomes of this study may provide insight into the optimal needle choice for evaluating the malignancy of pancreatic solid lesions, thus aiding in the development of practice guidelines for pancreatic diseases.
Trial registration
University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000030634. Registered on 29 December 2017.
Version number: 01.2017.12.28.
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Details
1 Wakayama Medical University, Second Department of Internal Medicine, Wakayama City, Japan (GRID:grid.412857.d) (ISNI:0000 0004 1763 1087)
2 Kyoto Second Red Cross Hospital, Department of Pathology, Kyoto, Japan (GRID:grid.415627.3) (ISNI:0000 0004 0595 5607); Kyoto Prefectural University of Medicine, Department of Surgical Pathology, Kyoto, Japan (GRID:grid.272458.e) (ISNI:0000 0001 0667 4960)
3 Wakayama Medical University, Clinical Study Support Center, Wakayama, Japan (GRID:grid.412857.d) (ISNI:0000 0004 1763 1087)
4 Kindai University Faculty of Medicine, Department of Gastroenterology and Hepatology, Osaka, Japan (GRID:grid.258622.9) (ISNI:0000 0004 1936 9967)
5 Osaka International Cancer Institute, Department of Hepatobiliary and Pancreatic Oncology, Osaka, Japan (GRID:grid.489169.b)
6 Osaka Medical College, The Second Department of Internal Medicine, Takatsuki, Japan (GRID:grid.444883.7) (ISNI:0000 0001 2109 9431)
7 Kyoto Prefectural University of Medicine, Department of Medicine, Division of Gastroenterology and Hepatology, Kyoto, Japan (GRID:grid.272458.e) (ISNI:0000 0001 0667 4960)
8 Kobe University Graduate School of Medicine, Division of Gastroenterology, Department of Internal Medicine, Kobe, Japan (GRID:grid.31432.37) (ISNI:0000 0001 1092 3077)
9 Nara Medical University, Department of Microbiology and Infectious Diseases, Nara, Japan (GRID:grid.410814.8) (ISNI:0000 0004 0372 782X)
10 Shiga University of Medical Science, Division of Gastroenterology, Otsu, Japan (GRID:grid.410827.8) (ISNI:0000 0000 9747 6806)
11 Japanese Red Cross Society of Wakayama Medical Center, Department of Gastroenterology and Hepatology, Wakayama, Japan (GRID:grid.414936.d) (ISNI:0000 0004 0418 6412)
12 Kitano Hospital, Tazuke Kofukai Medical Research Institute, Division of Gastroenterology and Hepatology, Digestive Disease Center, Osaka, Japan (GRID:grid.415392.8) (ISNI:0000 0004 0378 7849)
13 Kyoto Second Red Cross Hospital, Department of Gastroenterology, Kyoto, Japan (GRID:grid.415627.3) (ISNI:0000 0004 0595 5607)