Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: Study protocol for a controlled trial
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...
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| Format: | Article |
| Language: | English |
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BMC
2019-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-019-3946-7 |
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| author | Masahiro Itonaga Satoru Yasukawa Toshio Shimokawa Mamoru Takenaka Nobuyasu Fukutake Takeshi Ogura Junichi Sakagami Hideyuki Shiomi Yasushi Okura Osamu Inatomi Hisakazu Matsumoto Akira Kurita Azumi Suzuki Kiyohito Tanaka Masayuki Kitano |
| author_facet | Masahiro Itonaga Satoru Yasukawa Toshio Shimokawa Mamoru Takenaka Nobuyasu Fukutake Takeshi Ogura Junichi Sakagami Hideyuki Shiomi Yasushi Okura Osamu Inatomi Hisakazu Matsumoto Akira Kurita Azumi Suzuki Kiyohito Tanaka Masayuki Kitano |
| author_sort | Masahiro Itonaga |
| collection | DOAJ |
| description | 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. http://www.umin.ac.jp/ Version number: 01.2017.12.28. |
| first_indexed | 2024-12-14T03:07:52Z |
| format | Article |
| id | doaj.art-95f30b0d8d1b4cc9850e5639bbfcf92b |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T03:07:52Z |
| publishDate | 2019-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-95f30b0d8d1b4cc9850e5639bbfcf92b2022-12-21T23:19:21ZengBMCTrials1745-62152019-12-012011710.1186/s13063-019-3946-7Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: Study protocol for a controlled trialMasahiro Itonaga0Satoru Yasukawa1Toshio Shimokawa2Mamoru Takenaka3Nobuyasu Fukutake4Takeshi Ogura5Junichi Sakagami6Hideyuki Shiomi7Yasushi Okura8Osamu Inatomi9Hisakazu Matsumoto10Akira Kurita11Azumi Suzuki12Kiyohito Tanaka13Masayuki Kitano14Second Department of Internal Medicine, Wakayama Medical UniversityDepartment of Pathology, Kyoto Second Red Cross HospitalClinical Study Support Center, Wakayama Medical UniversityDepartment of Gastroenterology and Hepatology, Kindai University Faculty of MedicineDepartment of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer InstituteThe Second Department of Internal Medicine, Osaka Medical CollegeDepartment of Medicine, Division of Gastroenterology and Hepatology, Kyoto Prefectural University of MedicineDivision of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of MedicineDepartment of Microbiology and Infectious Diseases, Nara Medical UniversityDivision of Gastroenterology, Shiga University of Medical ScienceDepartment of Gastroenterology and Hepatology, Japanese Red Cross Society of Wakayama Medical CenterDivision of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research InstituteDepartment of Gastroenterology, Kyoto Second Red Cross HospitalDepartment of Gastroenterology, Kyoto Second Red Cross HospitalSecond Department of Internal Medicine, Wakayama Medical UniversityAbstract 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. http://www.umin.ac.jp/ Version number: 01.2017.12.28.https://doi.org/10.1186/s13063-019-3946-7EUS-FNAPuncture needleFranseen needlePancreatic massMalignancyDiagnostic yield |
| spellingShingle | Masahiro Itonaga Satoru Yasukawa Toshio Shimokawa Mamoru Takenaka Nobuyasu Fukutake Takeshi Ogura Junichi Sakagami Hideyuki Shiomi Yasushi Okura Osamu Inatomi Hisakazu Matsumoto Akira Kurita Azumi Suzuki Kiyohito Tanaka Masayuki Kitano Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: Study protocol for a controlled trial Trials EUS-FNA Puncture needle Franseen needle Pancreatic mass Malignancy Diagnostic yield |
| title | Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: Study protocol for a controlled trial |
| title_full | Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: Study protocol for a controlled trial |
| title_fullStr | Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: Study protocol for a controlled trial |
| title_full_unstemmed | Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: Study protocol for a controlled trial |
| title_short | Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: Study protocol for a controlled trial |
| title_sort | comparison of 22g standard and franseen needles in endoscopic ultrasound guided fine needle aspiration for diagnosing pancreatic mass lesions study protocol for a controlled trial |
| topic | EUS-FNA Puncture needle Franseen needle Pancreatic mass Malignancy Diagnostic yield |
| url | https://doi.org/10.1186/s13063-019-3946-7 |
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