Reinforced staplers for distal pancreatectomy

Manabu Kawai, Seiko Hirono, Ken ichi Okada, Sohei Satoi, Hiroaki Yanagimoto, Masanori Kon, Yoshiaki Murakami, Naru Kondo, Masayuki Sho, Takahiro Akahori, Hirochika Toyama, Takumi Fukumoto, Tsutomu Fujii, Ippei Matsumoto, Hidetoshi Eguchi, Hisashi Ikoma, Yutaka Takeda, Jiro Fujimoto, Hiroki Yamaue

研究成果: Contribution to journalArticle査読

13 被引用数 (Scopus)

抄録

Purpose: The safety and efficacy of reinforced staplers during distal pancreatectomy (DP) remain controversial because of the small sample size. This multicenter single-arm prospective study aims to evaluate the safety and efficacy of reinforced staplers with bioabsorbable material during DP. Methods: Between October 2014 and August 2015, 121 patients scheduled for DP were enrolled in this study at 11 institutions in Japan. The primary endpoint was the incidence of clinically relevant pancreatic fistula. Protocol treatment was defined as “distal pancreatectomy using reinforced staplers.” Results: Per-protocol analysis of 105 patients was performed; 16 of the patients were excluded based on discontinuation of protocol treatment criteria. Clinically relevant pancreatic fistula occurred in 13 (12.4%) of 105 patients. The overall morbidity rate was 29.5% (31 of 105 patients) and severe complication (Clavien classification IIIa or more) was 10.5% (11/105). Mortality rate was 0%, although reoperations were performed on two patients (1.9%). Multivariate logistic regression analysis of independent risk factors for clinically relevant pancreatic fistula after DP using reinforced stapler closure was 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 16.34). Conclusion: This study confirms the safety of reinforced staplers for pancreatic stump closure during DP. However, the efficacy of reinforced staplers for decreasing clinically relevant pancreatic fistula could not be drawn from this study. Trial registration: This prospective study was registered with ClinicalTrials.gov (NCT02270554) and UMIN Clinical Trial Registry (UMIN000015384).

本文言語英語
ページ(範囲)1197-1204
ページ数8
ジャーナルLangenbeck's Archives of Surgery
402
8
DOI
出版ステータス出版済み - 12 1 2017

All Science Journal Classification (ASJC) codes

  • Surgery

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