World Journal of Surgery

, Volume 43, Issue 1, pp 192–198 | Cite as

Safety and Feasibility of Linear Stapling Device with Bioabsorbable Polyglycolic Acid Sheet for Duodenal Closure in Gastric Cancer Surgery: A Multi-institutional Phase II Study

  • Kazunari Misawa
  • Takaki Yoshikawa
  • Seiji Ito
  • Haruhiko Cho
  • Yuichi Ito
  • Takashi Ogata
Original Scientific Report



Duodenal stump fistula (DSF) after gastrectomy is of low frequency but a critical complication in gastric cancer surgery. Manual oversewing for reinforcement of the duodenal stump is not applicable when free longitudinal margin is short and has technical difficulties in laparoscopic surgery. This trial evaluated the safety and feasibility of using a linear stapler with bioabsorbable polyglycolic acid (PGA) sheet for duodenal stump closure and reinforcement in gastric cancer surgery.


This multi-institutional, prospective phase II trial included gastric cancer patients who were scheduled to undergo distal or total gastrectomy with R-Y reconstruction. In all cases, duodenum was transected using a linear stapler with PGA sheet. The primary endpoint was the incidence of postoperative DSF. Sample size was set at 100 patients considering an expected value of 3% and threshold value of 8% with one-sided testing at a 10% significance level.


Between June 2014 and June 2015, a total of 100 patients were registered in this trial. Postoperative DSF was observed in two cases (2.0%, 90% CI 0.4–6.2%) which was developed on postoperative days 13 and 20. Intraoperative bleeding at the duodenal stump staple line was observed in one case but was easily controlled without additional suturing. Postoperative bleeding was not observed in any of the cases.


This study suggested that the use of PGA sheet as a reinforcement material for closure of the duodenal stump during gastrectomy for gastric cancer is both safe and feasible.

Trial registration number UMIN 000014398



This study was supported by a funding contribution from Medtronic (North Haven, CT, USA). However, the study sponsors had no role in the design of the study, data collection, analysis, or interpretation of the results, writing of the manuscript, or the decision to submit the manuscript for publication.

Compliance with Ethical Standards

Conflicts of interest

Takaki Yoshikawa received lecture fee from Covidien, Olympus, and Johnson and Johnson. The other authors declare no potential conflicts of interest.

Informed consent

Informed consent was obtained from all individual participants included in the study.


  1. 1.
    Cozzaglio L, Coladonato M, Biffi R et al (2010) Duodenal fistula after elective gastrectomy for malignant disease: an italian retrospective multicenter study. J Gastrointest Surg 14:805–811CrossRefGoogle Scholar
  2. 2.
    Orsenigo E, Bissolati M, Socci C et al (2014) Duodenal stump fistula after gastric surgery for malignancies: a retrospective analysis of risk factors in a single centre experience. Gastric Cancer 17:733–744CrossRefGoogle Scholar
  3. 3.
    Cozzaglio L, Giovenzana M, Biffi R et al (2016) Surgical management of duodenal stump fistula after elective gastrectomy for malignancy: an Italian retrospective multicenter study. Gastric Cancer 19:273–279CrossRefGoogle Scholar
  4. 4.
    Paik HJ, Lee SH, Choi CI et al (2016) Duodenal stump fistula after gastrectomy for gastric cancer: risk factors, prevention, and management. Ann Surg Treat Res 90:157–163CrossRefGoogle Scholar
  5. 5.
    Cornejo Mde L, Priego P, Ramos D et al (2016) Duodenal fistula after gastrectomy: retrospective study of 13 new cases. Rev Esp Enferm Dig 108:20–26Google Scholar
  6. 6.
    Cai ZH, Zang L, Yang HK et al (2017) Survey on laparoscopic total gastrectomy at the 11th China–Korea–Japan Laparoscopic Gastrectomy Joint Seminar. Asian J Endosc Surg 10:259–267CrossRefGoogle Scholar
  7. 7.
    Consten EC, Gagner M, Pomp A et al (2004) Decreased bleeding after laparoscopic sleeve gastrectomy with or without duodenal switch for morbid obesity using a stapled buttressed absorbable polymer membrane. Obes Surg 14:1360–1366CrossRefGoogle Scholar
  8. 8.
    Gagner M, Buchwald JN (2014) Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. Surg Obes Relat Dis 10:713–723CrossRefGoogle Scholar
  9. 9.
    Shikora SA, Mahoney CB (2015) Clinical benefit of gastric staple line reinforcement (SLR) in gastrointestinal surgery: a meta-analysis. Obes Surg 25:1133–1141CrossRefGoogle Scholar
  10. 10.
    Kanda Y (2013) Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transpl 48:452–458CrossRefGoogle Scholar
  11. 11.
    Dindo D, Demartines N, Clavien P-A (2004) Classification of surgical complications. Ann Surg 240:205–213CrossRefGoogle Scholar
  12. 12.
    Katayama H, Kurokawa Y, Nakamura K et al (2016) Extended Clavien–Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria. Surg Today 46:668–685CrossRefGoogle Scholar
  13. 13.
    Akashi Y, Hiki N, Nunobe S et al (2012) Safe management of anastomotic leakage after gastric cancer surgery with enteral nutrition via a nasointestinal tube. Langenbecks Arch Surg 397:737–744CrossRefGoogle Scholar
  14. 14.
    Kodera Y, Yoshida K, Kumamaru H, et al (2018) Introducing laparoscopic total gastrectomy for gastric cancer in general practice: a retrospective cohort study based on a nationwide registry database in Japan. Gastric Cancer. Google Scholar
  15. 15.
    Yoshida K, Honda M, Kumamaru H et al (2018) Surgical outcomes of laparoscopic distal gastrectomy compared to open distal gastrectomy: a retrospective cohort study based on a nationwide registry database in Japan. Ann Gastroenterol Surg 2:55–64CrossRefGoogle Scholar
  16. 16.
    Sano T, Sasako M, Mizusawa J et al (2017) Randomized controlled trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma. Ann Surg 265:277–283CrossRefGoogle Scholar
  17. 17.
    Katai H, Mizusawa J, Katayama H et al (2017) Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912. Gastric Cancer 20:699–708CrossRefGoogle Scholar
  18. 18.
    Yu HW, Jung DH, Son SY et al (2013) Risk factors of postoperative pancreatic fistula in curative gastric cancer surgery. J Gastric Cancer 13:179–184CrossRefGoogle Scholar
  19. 19.
    Kung CH, Lindblad M, Nilsson M et al (2014) Postoperative pancreatic fistula formation according to ISGPF criteria after D2 gastrectomy in Western patients. Gastric Cancer 17:571–577CrossRefGoogle Scholar
  20. 20.
    Kurokawa Y, Doki Y, Mizusawa J, et al (2018) Bursectomy versus omentectomy alone for resectable gastric cancer (JCOG1001): a phase 3, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol 3:460–468CrossRefGoogle Scholar

Copyright information

© Société Internationale de Chirurgie 2018

Authors and Affiliations

  1. 1.Department of Gastroenterological SurgeryAichi Cancer Center HospitalNagoyaJapan
  2. 2.Department of Gastrointestinal SurgeryKanagawa Cancer CenterYokohamaJapan

Personalised recommendations