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04.11.2017 | ORIGINAL ARTICLE | Ausgabe 8/2017

Langenbeck's Archives of Surgery 8/2017

Reinforced staplers for distal pancreatectomy

Zeitschrift:
Langenbeck's Archives of Surgery > Ausgabe 8/2017
Autoren:
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

Abstract

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).

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