{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T14:34:35Z","timestamp":1781015675352,"version":"3.54.1"},"reference-count":40,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2021,11,28]],"date-time":"2021-11-28T00:00:00Z","timestamp":1638057600000},"content-version":"unspecified","delay-in-days":27,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001659","name":"Deutsche Forschungsgemeinschaft","doi-asserted-by":"publisher","award":["WE 2008\/9-0"],"award-info":[{"award-number":["WE 2008\/9-0"]}],"id":[{"id":"10.13039\/501100001659","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,10,12]]},"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Partial pancreatoduodenectomy (PD) is the treatment of choice for various benign and malignant tumours of the pancreatic head or the periampullary region. For reconstruction of the gastrointestinal passage, two stomach-preserving PD variants exist: pylorus preservation PD (ppPD) or pylorus resection PD (prPD) with preservation of the stomach. In pancreatic surgery, delayed gastric emptying (DGE) remains a serious complication after PD with an incidence varying between 4.5% and 45%, potentially delaying hospital discharge or further treatment, for example, adjuvant chemotherapy. Evidence is lacking to assess, which variant of PD entails fewer postoperative DGE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The protocol of a large-scale, multicentre, pragmatic, two-arm parallel-group, registry-based randomised controlled trial (rRCT) using a two-stage group-sequential design is presented. This patient-blind rRCT aims to demonstrate the superiority of prPD over ppPD with respect to the overall incidence of DGE within 30 days after index surgery in a German real-world setting. A total of 984 adults undergoing elective PD for any indication will be randomised in a 1:1 ratio. Patients will be recruited at about 30 hospitals being members of the StuDoQ|Pancreas registry established by the German Society of General and Visceral Surgery. The postoperative follow-up for each patient will be 30 days. The primary analysis will follow an intention-to-treat approach and applies a binary logistic random intercepts model. Secondary perioperative outcomes include overall severe morbidity (Clavien-Dindo classification), blood loss, 30-day all-cause mortality, postoperative hospital stay and operation time. Complication rates and adverse events will be closely monitored.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>\n                      This protocol was approved by the leading ethics committee of the Medical Faculty of the Ludwig-Maximilians-Universit\u00e4t, Munich (reference number 19-221). The results will be published in a peer-reviewed journal and presented at international conferences. Study findings will also be disseminated via the website (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.dgav.de\/studoq\/pylorespres\/\">http:\/\/www.dgav.de\/studoq\/pylorespres\/<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>DRKS-ID: DRKS00018842.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-056191","type":"journal-article","created":{"date-parts":[[2021,11,29]],"date-time":"2021-11-29T11:11:51Z","timestamp":1638184311000},"page":"e056191","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Pylorus resection versus pylorus preservation in pancreatoduodenectomy (PyloResPres): study protocol and statistical analysis plan for a German multicentre, single-blind, surgical, registry-based randomised controlled trial"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9574-8051","authenticated-orcid":false,"given":"Bernhard W","family":"Renz","sequence":"first","affiliation":[{"name":"Department of General, Visceral and Transplantation Surgery, University Hospital, Ludwig-Maximilians-University (LMU), Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2408-2533","authenticated-orcid":false,"given":"Christine","family":"Adrion","sequence":"additional","affiliation":[{"name":"Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig-Maximilians-University (LMU), Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carsten","family":"Klinger","sequence":"additional","affiliation":[{"name":"German Society for General and Visceral Surgery (DGAV), Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9597-1368","authenticated-orcid":false,"given":"Matthias","family":"Ilmer","sequence":"additional","affiliation":[{"name":"Department of General, Visceral and Transplantation Surgery, University Hospital, Ludwig-Maximilians-University (LMU), Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7827-8753","authenticated-orcid":false,"given":"Jan G","family":"D\u2019Haese","sequence":"additional","affiliation":[{"name":"Department of General, Visceral and Transplantation Surgery, University Hospital, Ludwig-Maximilians-University (LMU), Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heinz-J","family":"Buhr","sequence":"additional","affiliation":[{"name":"German Society for General and Visceral Surgery (DGAV), Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9955-8906","authenticated-orcid":false,"given":"Ulrich","family":"Mansmann","sequence":"additional","affiliation":[{"name":"Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig-Maximilians-University (LMU), Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens","family":"Werner","sequence":"additional","affiliation":[{"name":"Department of General, Visceral and Transplantation Surgery, University Hospital, Ludwig-Maximilians-University (LMU), Munich, 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