{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T18:17:53Z","timestamp":1771265873958,"version":"3.50.1"},"reference-count":20,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,8,13]],"date-time":"2018-08-13T00:00:00Z","timestamp":1534118400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2018,8,13]],"date-time":"2018-08-13T00:00:00Z","timestamp":1534118400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["World j. surg."],"published-print":{"date-parts":[[2019,1,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multi\u2010institutional, prospective phase II trial included gastric cancer patients who were scheduled to undergo distal or total gastrectomy with R\u2010Y 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\u2010sided testing at a 10% significance level.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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\u20136.2%) 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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.<\/jats:p><jats:p><jats:italic>Trial registration number<\/jats:italic> UMIN 000014398<\/jats:p><\/jats:sec>","DOI":"10.1007\/s00268-018-4748-x","type":"journal-article","created":{"date-parts":[[2018,8,13]],"date-time":"2018-08-13T14:24:30Z","timestamp":1534170270000},"page":"192-198","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Safety and Feasibility of Linear Stapling Device with Bioabsorbable Polyglycolic Acid Sheet for Duodenal Closure in Gastric Cancer Surgery: A Multi\u2010institutional Phase II Study"],"prefix":"10.1002","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2047-3919","authenticated-orcid":false,"given":"Kazunari","family":"Misawa","sequence":"first","affiliation":[{"name":"Department of Gastroenterological Surgery Aichi Cancer Center Hospital 1\u20101 Kanokoden, Chikusa\u2010Ku 464\u20108681 Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takaki","family":"Yoshikawa","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal Surgery Kanagawa Cancer Center 1\u20101\u20102 Nakao, Asahi\u2010Ku 241\u20100815 Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seiji","family":"Ito","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery Aichi Cancer Center Hospital 1\u20101 Kanokoden, Chikusa\u2010Ku 464\u20108681 Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haruhiko","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal Surgery Kanagawa Cancer Center 1\u20101\u20102 Nakao, Asahi\u2010Ku 241\u20100815 Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuichi","family":"Ito","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery Aichi Cancer Center Hospital 1\u20101 Kanokoden, Chikusa\u2010Ku 464\u20108681 Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Ogata","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal Surgery Kanagawa Cancer Center 1\u20101\u20102 Nakao, Asahi\u2010Ku 241\u20100815 Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,8,13]]},"reference":[{"key":"e_1_2_7_2_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11605\u2010010\u20101166\u20102"},{"key":"e_1_2_7_3_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10120\u2010013\u20100327\u2010x"},{"key":"e_1_2_7_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10120\u2010014\u20100445\u20100"},{"key":"e_1_2_7_5_2","doi-asserted-by":"publisher","DOI":"10.4174\/astr.2016.90.3.157"},{"key":"e_1_2_7_6_2","first-page":"20","article-title":"Duodenal fistula after gastrectomy: retrospective study of 13 new cases","volume":"108","author":"Cornejo Mde L","year":"2016","journal-title":"Rev Esp Enferm Dig"},{"key":"e_1_2_7_7_2","doi-asserted-by":"publisher","DOI":"10.1111\/ases.12362"},{"key":"e_1_2_7_8_2","doi-asserted-by":"publisher","DOI":"10.1381\/0960892042583905"},{"key":"e_1_2_7_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.soard.2014.01.016"},{"key":"e_1_2_7_10_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11695\u2010015\u20101703\u2010x"},{"key":"e_1_2_7_11_2","doi-asserted-by":"publisher","DOI":"10.1038\/bmt.2012.244"},{"key":"e_1_2_7_12_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.sla.0000133083.54934.ae"},{"key":"e_1_2_7_13_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00595\u2010015\u20101236\u2010x"},{"key":"e_1_2_7_14_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00423\u2010012\u20100935\u20107"},{"key":"e_1_2_7_15_2","unstructured":"KoderaY YoshidaK KumamaruHet al. 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The other authors declare no potential conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}