A prospective multicenter study of endoscopic ultrasound‐guided fine needle biopsy using a 22‐gauge Franseen needle for pancreatic solid lesions. Issue 10 (14th May 2021) - Ishigaki, Kazunaga
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.