A Multicenter, Randomized, Controlled Trial Comparing Reinforced Staplers with Bare Staplers During Distal Pancreatectomy (HiSCO-07 Trial)
- 129 Downloads
Although distal pancreatectomy (DP) using a reinforced stapler is expected to reduce PF, no multicenter RCT has been performed. To investigate whether reinforced staplers reduce the incidence of clinically relevant pancreatic fistula (PF) after DP compared with staplers without reinforcement.
Between July 2016 and December 2017, patients scheduled for DP were enrolled in a multicenter, randomized, controlled trial (RCT) at nine hospitals in Hiroshima Japan. Patients were randomized either to reinforced stapler or bare stapler. The primary endpoint was incidence of clinically relevant PF. This RCT was registered with UMIN Clinical Trial Registry (UMIN000022341).
A total of 122 patients were assigned to reinforced stapler (n = 61) or bare stapler (n = 61), and 119 patients (61 reinforced stapler and 59 bare stapler) were analyzed. There was no significant difference in the incidence of clinically relevant PF between the reinforced stapler and bare stapler groups (16.3% vs. 27.1%, p = 0.15). Furthermore, the rates of major complication (16.3% vs. 18.6%, p = 0.74), postpancreatectomy hemorrhage (0% vs. 3.4%, p = 0.08), and median postoperative in-hospital days (19 days vs. 20 days, p = 0.78) did not differ between the two groups. Within a subset of 82 patients in whom the thickness of pancreatic transection line was less than 14 mm, a significant difference was found in the incidence of clinically relevant PF (4.5% vs. 21.0% in the reinforced stapler vs. bare stapler groups, respectively, p = 0.01).
Reinforced stapler for pancreatic transection during DP does not reduce the incidence of clinically relevant PF compared to stapler without reinforcement.
Study concepts: Naru Kondo, Kenichiro Uemura, Takeshi Sudo, Hiroyoshi Matstukawa, Shintaro Kuroda, Yoshiaki Murakami. Study design: Naru Kondo, Naoto Hadano, Daisuke Satoh, Masaru Sasaki, Tomoyuki Abe, Saburo Fukuda, Akihiko Oshita, Akira Nakashima, Yasushi Hashimoto. Data acquisition: Naru Kondo, Naoto Hadano, Naoya Nakagawa, Kenjiro Okada, Daisuke Satoh, Masaru Sasaki, Tomoyuki Abe, Saburo Fukuda, Akihiko Oshita, Akira Nakashima, Yasushi Hashimoto. Quality control of data and algorithms: Hideki Ohdan, Yoshiaki Murakami. Data analysis and interpretation: Naru Kondo, Naoya Nakagawa, Kenjiro Okada, Shintaro Kuroda. Statistical analysis: Naru Kondo, Kenichiro Uemura, Kenjiro Okada, Naoya Nakagawa. Manuscript preparation: Naru Kondo, Takeshi Sudo, Hiroyoshi Matstukawa, Masaru Sasaki, Tomoyuki Abe, Saburo Fukuda, Akihiko Oshita, Akira Nakashima,Yasushi Hashimoto. Manuscript editing: Yoshiaki Murakami, Kenichiro Uemura, Hideki Ohdan. Manuscript review: Naru Kondo, Yoshiaki Murakami.
None of the authors has any commercial interests associated with this study.
This study was conducted in compliance with the ethical principles of the Declaration of Helsinki and the protocol was approved by the institutional review board at each participating institution. All patients provided written informed consent before enrollment in the study.
- 22.Subhedar PD, Patel SH, Kneuertz PJ, et al. Risk factors for pancreatic fistula after stapled gland transection. Am Surg. 2011;77:965–70.Google Scholar