{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T03:01:14Z","timestamp":1789182074344,"version":"build-2803163510"},"reference-count":31,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,2,29]],"date-time":"2024-02-29T00:00:00Z","timestamp":1709164800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100018254","name":"Japanese Foundation for Research and Promotion of Endoscopy","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100018254","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Gastro and Hepatol"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aim<\/jats:title>\n                    <jats:p>The 10\u2010mm self\u2010expandable metal stent (SEMS) is the standard for endoscopic transpapillary biliary drainage before pancreatic cancer surgery. However, the efficacy of stents thinner than 10\u00a0mm has not been adequately validated. Therefore, we aimed to evaluate the safety of a 6\u2010mm fully covered SEMS (FCSEMS) for distal malignant biliary obstruction (DMBO) during preoperative chemotherapy for pancreatic cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a single\u2010arm, multicenter, prospective phase II study of endoscopic transpapillary initial biliary drainage for DMBO before pancreatic cancer surgery. The primary endpoint was stent\u2010related adverse events, and the key secondary endpoint was the non\u2010recurrent biliary obstruction (non\u2010RBO) rate during the observation period for both resectable (R) and borderline resectable (BR) pancreatic cancers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The study enrolled 33 patients, among whom 32 received the study treatment. There were 23 and 9 cases of R and BR pancreatic cancers, respectively. The technical and clinical success rates were 97.0% and 90.1%, respectively. The stent\u2010related adverse event rate was 3.1% (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a01, acute pancreatitis) (95% confidential interval, 0.00\u201316.2), which met the criteria to be considered safe. The overall non\u2010RBO rate during the observation period (median 96\u00a0days) was 78.1% (82.6% and 66.7% for R and BR pancreatic cancer cases, respectively).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The 6\u2010mm FCSEMS is an extremely safe metallic stent with a low stent\u2010related adverse event rate of 3.1% for preoperative biliary drainage in pancreatic cancer. It is considered the optimal stent for preoperative biliary drainage in terms of the non\u2010RBO rate. UMIN Clinical Trial Registry (UMIN\u2010CTR 000041704).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jgh.16524","type":"journal-article","created":{"date-parts":[[2024,2,29]],"date-time":"2024-02-29T06:19:25Z","timestamp":1709187565000},"page":"1442-1449","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Safety of biliary drainage with 6\u2010mm metallic stent for preoperative obstructive jaundice in pancreatic cancer: PURPLE SIX STUDY"],"prefix":"10.1111","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-1677-2969","authenticated-orcid":false,"given":"Shota","family":"Harai","sequence":"first","affiliation":[{"name":"Department of Hepatobiliary and Pancreatic Oncology National Cancer Center Hospital  Tokyo Japan"},{"name":"Department of Gastroenterology University of Yamanashi Faculty of Medicine Graduate School of Medicine  Yamanashi 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