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A Multicenter, Randomized, Controlled Trial Comparing Reinforced Staplers with Bare Staplers During Distal Pancreatectomy (HiSCO-07 Trial)

  • Pancreatic Tumors
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

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.

Methods

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).

Results

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).

Conclusions

Reinforced stapler for pancreatic transection during DP does not reduce the incidence of clinically relevant PF compared to stapler without reinforcement.

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References

  1. Ferrone CR, Warshaw AL, Rattner DW, et al. Pancreatic fistula rates after 462 distal pancreatectomies: staplers do not decrease fistula rates. J Gastrointest Surg. 2008;12:1691–7. (discussion 1697–8).

    Article  PubMed  PubMed Central  Google Scholar 

  2. Sell NM, Pucci MJ, Gabale S, et al. The influence of transection site on the development of pancreatic fistula in patients undergoing distal pancreatectomy: a review of 294 consecutive cases. Surgery. 2015;157:1080–7.

    Article  PubMed  Google Scholar 

  3. Harris LJ, Abdollahi H, Newhook T, et al. Optimal technical management of stump closure following distal pancreatectomy: a retrospective review of 215 cases. J Gastrointest Surg. 2010;14:998–1005.

    Article  PubMed  Google Scholar 

  4. Goh BK, Tan YM, Chung YF, et al. Critical appraisal of 232 consecutive distal pancreatectomies with emphasis on risk factors, outcome, and management of the postoperative pancreatic fistula: a 21-year experience at a single institution. Arch Surg. 2008;143:956–65.

    Article  PubMed  Google Scholar 

  5. Kawai M, Hirono S, Okada K, et al. Randomized controlled trial of pancreaticojejunostomy versus stapler closure of the pancreatic stump during distal pancreatectomy to reduce pancreatic fistula. Ann Surg. 2016;264:180–7.

    Article  PubMed  Google Scholar 

  6. Jang JY, Shin YC, Han Y, et al. Effect of polyglycolic acid mesh for prevention of pancreatic fistula following distal pancreatectomy: a randomized clinical trial. JAMA Surg. 2017;152:150–5.

    Article  PubMed  Google Scholar 

  7. Uemura K, Satoi S, Motoi F, Kwon M, Unno M, Murakami Y. Randomized clinical trial of duct-to-mucosa pancreaticogastrostomy versus handsewn closure after distal pancreatectomy. Br J Surg. 2017;104:536–43.

    Article  CAS  PubMed  Google Scholar 

  8. Diener MK, Seiler CM, Rossion I, et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011;377:1514–22.

    Article  PubMed  Google Scholar 

  9. Jimenez RE, Mavanur A, Macaulay WP. Staple line reinforcement reduces postoperative pancreatic stump leak after distal pancreatectomy. J Gastrointest Surg. 2007;11:345–9.

    Article  PubMed  Google Scholar 

  10. Thaker RI, Matthews BD, Linehan DC, Strasberg SM, Eagon JC, Hawkins WG. Absorbable mesh reinforcement of a stapled pancreatic transection line reduces the leak rate with distal pancreatectomy. J Gastrointest Surg. 2007;11:59–65.

    Article  PubMed  Google Scholar 

  11. Yamamoto M, Hayashi MS, Nguyen NT, Nguyen TD, McCloud S, Imagawa DK. Use of Seamguard to prevent pancreatic leak following distal pancreatectomy. Arch Surg. 2009;144:894–9.

    Article  PubMed  Google Scholar 

  12. Hamilton NA, Porembka MR, Johnston FM, et al. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy: a single-blinded, randomized controlled trial. Ann Surg. 2012;255:1037–42.

    Article  PubMed  Google Scholar 

  13. Kawai M, Hirono S, Okada KI, et al. Reinforced staplers for distal pancreatectomy. Langenbecks Arch Surg. 2017;402:1197–204.

    Article  PubMed  Google Scholar 

  14. Jensen EH, Portschy PR, Chowaniec J, Teng M. Meta-analysis of bioabsorbable staple line reinforcement and risk of fistula following pancreatic resection. J Gastrointest Surg. 2013;17:267–72.

    Article  PubMed  Google Scholar 

  15. Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005;138:8–13.

    Article  PubMed  Google Scholar 

  16. Bassi C, Marchegiani G, Dervenis C, et al. The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 years after. Surgery. 2017;161:584–91.

    Article  PubMed  Google Scholar 

  17. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–13.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Wente MN, Veit JA, Bassi C, et al. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142:20–5.

    Article  PubMed  Google Scholar 

  19. Johnston FM, Cavataio A, Strasberg SM, et al. The effect of mesh reinforcement of a stapled transection line on the rate of pancreatic occlusion failure after distal pancreatectomy: review of a single institution’s experience. HPB (Oxford). 2009;11:25–31.

    Article  Google Scholar 

  20. Kawai M, Tani M, Okada K, et al. Stump closure of a thick pancreas using stapler closure increases pancreatic fistula after distal pancreatectomy. Am J Surg. 2013;206:352–9.

    Article  PubMed  Google Scholar 

  21. Eguchi H, Nagano H, Tanemura M, et al. A thick pancreas is a risk factor for pancreatic fistula after a distal pancreatectomy: selection of the closure technique according to the thickness. Dig Surg. 2011;28:50–6.

    Article  PubMed  Google Scholar 

  22. Subhedar PD, Patel SH, Kneuertz PJ, et al. Risk factors for pancreatic fistula after stapled gland transection. Am Surg. 2011;77:965–70.

    PubMed  Google Scholar 

  23. Sepesi B, Moalem J, Galka E, Salzman P, Schoeniger LO. The influence of staple size on fistula formation following distal pancreatectomy. J Gastrointest Surg. 2012;16:267–74.

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. Department of Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan

    Naru Kondo MD, Kenichiro Uemura MD, Naoya Nakagawa MD, Kenjiro Okada MD & Yoshiaki Murakami MD

  2. Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan

    Shintaro Kuroda MD & Hideki Ohdan MD

  3. Department of Surgery, Kure Medical Center and Chugoku Cancer Center, Kure, Japan

    Takeshi Sudo MD & Naoto Hadano MD

  4. Department of Gastroenterological Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan

    Hiroyoshi Matstukawa MD & Daisuke Satoh MD

  5. Department of Surgery, Hiroshima General Hospital, Hatsukaichi, Japan

    Masaru Sasaki MD

  6. Department of Surgery, Onomichi General Hospital, Onomichi, Japan

    Tomoyuki Abe MD

  7. Department of Surgery, Chugoku Rosai Hospital, Kure, Japan

    Saburo Fukuda

  8. Department of Gastroenterological Surgery, Hiroshima Prefectural Hospital, Hiroshima, Japan

    Akihiko Oshita MD

  9. Department of Surgery, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan

    Akira Nakashima MD

  10. Department of Surgery, Hiroshima Memorial Hospital, Hiroshima, Japan

    Yasushi Hashimoto MD

Authors
  1. Naru Kondo MD
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  2. Kenichiro Uemura MD
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  3. Naoya Nakagawa MD
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  4. Kenjiro Okada MD
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  5. Shintaro Kuroda MD
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  6. Takeshi Sudo MD
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  7. Naoto Hadano MD
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  8. Hiroyoshi Matstukawa MD
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  9. Daisuke Satoh MD
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  10. Masaru Sasaki MD
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  11. Tomoyuki Abe MD
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  12. Saburo Fukuda
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  13. Akihiko Oshita MD
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  14. Akira Nakashima MD
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  15. Yasushi Hashimoto MD
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  16. Hideki Ohdan MD
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  17. Yoshiaki Murakami MD
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Consortia

the Hiroshima Surgical Study Group of Clinical Oncology

Contributions

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.

Corresponding author

Correspondence to Yoshiaki Murakami MD.

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Disclosure

None of the authors has any commercial interests associated with this study.

Ethical Approval

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.

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Kondo, N., Uemura, K., Nakagawa, N. et al. A Multicenter, Randomized, Controlled Trial Comparing Reinforced Staplers with Bare Staplers During Distal Pancreatectomy (HiSCO-07 Trial). Ann Surg Oncol 26, 1519–1527 (2019). https://doi.org/10.1245/s10434-019-07222-0

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  • DOI: https://doi.org/10.1245/s10434-019-07222-0

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