Purpose The safety and efficacy of reinforced staplers during 16 of the patients were excluded based on discontinuation of distal pancreatectomy (DP) remain controversial because of protocol treatment criteria. Clinically relevant pancreatic fis- the small sample size. This multicenter single-arm prospective tula occurred in 13 (12.4%) of 105 patients. The overall mor- study aims to evaluate the safety and efficacy of reinforced bidity rate was 29.5% (31 of 105 patients) and severe compli- staplers with bioabsorbable material during DP. cation (Clavien classification IIIa or more) was 10.5% (11/ Methods Between October 2014 and August 2015, 121 pa- 105). Mortality rate was 0%, although reoperations were per- tients scheduled for DP were enrolled in this study at 11 insti- formed on two patients (1.9%). Multivariate logistic regres- tutions in Japan. The primary endpoint was the incidence of sion analysis of independent risk factors for clinically relevant clinically relevant pancreatic fistula. Protocol treatment was pancreatic fistula after DP using reinforced stapler closure was defined as Bdistal pancreatectomy using reinforced staplers.^ operative time more than 240 min (P= 0.047, odds ratio 5.79), registration numbers less than 10 (P= 0.046, odds ratio 13.01), and staple line hemorrhage (P= 0.003, odds ratio * Hiroki
Langenbeck's Archives of Surgery – Springer Journals
Published: Nov 4, 2017
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