Kazunaga Ishigaki1, Yousuke Nakai1,2, Naoki Sasahira3, Kazuya Sugimori4, Katsuya Kitamura5,6, Tomohisa Iwai7, Saburo Matsubara8, Kenji Shimura9, Takao Itoi10, Shomei Ryozawa11, Jun Ushio12, Shinpei Doi13, Hiroo Imazu14, Iruru Maetani15, Hiroyuki Isayama16. 1. Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan. 2. Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan. 3. Department of Gastroenterology, Cancer Institute Hospital of JFCR, Tokyo, Japan. 4. Gastroentelogical Center, Yokohama City University Medical Center, Yokohama, Japan. 5. Department of Gastroenterology and Hepatology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan. 6. Division of Gastroenterology, Department of Medicine, School of Medicine, Showa University, Tokyo, Japan. 7. Department of Gastroenterology, Kitasato University Hospital, Sagamihara, Japan. 8. Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan. 9. Department of Gastroenterology, Asahi General Hospital, Chiba, Japan. 10. Department of Gastroenterology, Tokyo Medical University Hospital, Tokyo, Japan. 11. Department of Gastroenterology, Saitama Medical University International Medical Center, Saitama, Japan. 12. Department of Gastroenterology, Jichi Medical University Hospital, Tochigi, Japan. 13. Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan. 14. Department of Gastroenterology, Nihon University Itabashi Hospital, Tokyo, Japan. 15. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan. 16. Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Abstract
BACKGROUND AND AIM: While encouraging data of endoscopic ultrasound (EUS)-guided fine-needle biopsy (EUS-FNB) using a 22-gauge Franseen needle have been reported, large-scale data of per pass and quantitative analyses are still lacking. METHODS: This was a multicenter prospective study of EUS-FNB using the 22-gauge Franseen needle for a pancreatic solid lesion. Cytological and histological analyses per pass were evaluated and semi-quantitative analyses were performed on core tissue and blood contamination. Primary end-point was diagnostic accuracy per session. Prognostic factors were analyzed for diagnostic accuracy, sensitivity, core tissue, and blood contamination. RESULTS: A total of 629 passes were performed in 244 cases at 14 centers between 2018 and 2019. The median tumor size was 29 mm, and the puncture was transduodenal in 43%. The median pass number was 2. Diagnostic accuracy per session, at a first pass, and per pass were 93%, 90%, and 88%. In 198 cases with pancreatic cancer, diagnostic sensitivity per session, at a first pass, and per pass were 94%, 89%, and 89%. The rates of core tissue score of 4 and blood contamination score of 3 were 50% and 47%. The adverse event rate was 1.6%. In the multivariate analysis, tumor size ≤20 mm (odds ratio [OR] of 0.46, P = 0.03), transduodenal puncture (OR of 0.53, P = 0.04), and suction (OR of 0.16, P = 0.01) were associated with lower diagnostic accuracy. CONCLUSIONS: The EUS-FNB using the 22-gauge Franseen needle for pancreatic solid lesions showed high per pass and overall diagnostic accuracy.
BACKGROUND AND AIM: While encouraging data of endoscopic ultrasound (EUS)-guided fine-needle biopsy (EUS-FNB) using a 22-gauge Franseen needle have been reported, large-scale data of per pass and quantitative analyses are still lacking. METHODS: This was a multicenter prospective study of EUS-FNB using the 22-gauge Franseen needle for a pancreatic solid lesion. Cytological and histological analyses per pass were evaluated and semi-quantitative analyses were performed on core tissue and blood contamination. Primary end-point was diagnostic accuracy per session. Prognostic factors were analyzed for diagnostic accuracy, sensitivity, core tissue, and blood contamination. RESULTS: A total of 629 passes were performed in 244 cases at 14 centers between 2018 and 2019. The median tumor size was 29 mm, and the puncture was transduodenal in 43%. The median pass number was 2. Diagnostic accuracy per session, at a first pass, and per pass were 93%, 90%, and 88%. In 198 cases with pancreatic cancer, diagnostic sensitivity per session, at a first pass, and per pass were 94%, 89%, and 89%. The rates of core tissue score of 4 and blood contamination score of 3 were 50% and 47%. The adverse event rate was 1.6%. In the multivariate analysis, tumor size ≤20 mm (odds ratio [OR] of 0.46, P = 0.03), transduodenal puncture (OR of 0.53, P = 0.04), and suction (OR of 0.16, P = 0.01) were associated with lower diagnostic accuracy. CONCLUSIONS: The EUS-FNB using the 22-gauge Franseen needle for pancreatic solid lesions showed high per pass and overall diagnostic accuracy.