{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,2]],"date-time":"2025-08-02T19:00:46Z","timestamp":1754161246283,"version":"3.41.2"},"reference-count":29,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T00:00:00Z","timestamp":1753660800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100010449","name":"Nationales Centrum f\u00fcr Tumorerkrankungen Heidelberg","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100010449","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec>\n<jats:title>Introduction<\/jats:title>\n<jats:p>Pancreatic surgery remains associated with significant morbidity. Pancreatoduodenectomy (PD) with high-risk stigmata for postoperative pancreatic fistula (POPF) may delay or hinder administration of adjuvant therapy. Total pancreatectomy (TP) prevents POPF-associated complications but implies permanent exocrine and endocrine insufficiency. Islet autotransplantation (IAT) has the potential to compensate endocrine function.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Methods and analysis<\/jats:title>\n<jats:p>XANDTX is a single-centre randomized controlled pilot trial comparing high-risk PD with TP and simultaneous IAT in patients with periampullary cancer. After screening for eligibility and obtaining informed consent, a total of 32 adult patients will be intraoperatively randomized in a 1:1 ratio. The primary hypothesis is that TP with IAT prevents POPF-associated complications and leads to a shorter period to initiation of adjuvant therapy and a higher overall rate of adjuvant therapy administration.<\/jats:p>\n<jats:p>Secondary endpoints include perioperative morbidity and mortality, metabolic outcome, quality of life (QoL) and oncological long-term outcome. Each patient will be followed up for 5 years.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Discussion<\/jats:title>\n<jats:p>The XANDTX pilot trial will aim to provide surgical and oncological feasibility and safety data of total pancreatectomy with simultaneous islet autotransplantation in management of resectable periampullary cancer. The results will form the basis for a further confirmatory controlled study.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>This study was registered on ClinicalTrials.gov (NCT05843877) on February 27, 2023 and EudraCT (2023-507773-17-00) on April 18, 2024.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0327949","type":"journal-article","created":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T17:48:48Z","timestamp":1753724928000},"page":"e0327949","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pancreatoduodenectomy versus total pancreatectomy and simultaneous intraportal islet autotransplantation for periampullary cancer at high-risk of postoperative pancreatic fistula (XANDTX-trial): Protocol of a randomized controlled pilot trial"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4268-9902","authenticated-orcid":true,"given":"Sebastian","family":"Hempel","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2265-4809","authenticated-orcid":true,"given":"Fiona R.","family":"Kolbinger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florian","family":"Oehme","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olga","family":"Radulova-Mauersberger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janine","family":"Schmid","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Undine","family":"Schubert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florian","family":"Schepp","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Bornstein","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"Korn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Evelyn","family":"Trips","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00fcrgen","family":"Weitz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marius","family":"Distler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Ludwig","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,7,28]]},"reference":[{"issue":"3","key":"pone.0327949.ref001","doi-asserted-by":"crossref","first-page":"411","DOI":"10.1097\/SLA.0000000000002248","article-title":"Effect of Hospital Volume on In-hospital Morbidity and Mortality Following Pancreatic Surgery in Germany","volume":"267","author":"C Krautz","year":"2018","journal-title":"Ann Surg"},{"key":"pone.0327949.ref002","article-title":"A simple classification of pancreatic duct size and texture predicts postoperative pancreatic fistula: A classification of the International Study Group of Pancreatic Surgery (ISGPS)","author":"F Schuh","year":"2021","journal-title":"Ann Surg"},{"issue":"5","key":"pone.0327949.ref003","doi-asserted-by":"crossref","first-page":"937","DOI":"10.1097\/SLA.0000000000002620","article-title":"Alternative Fistula Risk Score for Pancreatoduodenectomy (a-FRS): Design and International External Validation","volume":"269","author":"TH Mungroop","year":"2019","journal-title":"Ann Surg"},{"issue":"11","key":"pone.0327949.ref004","doi-asserted-by":"crossref","first-page":"992","DOI":"10.1016\/j.hpb.2018.04.003","article-title":"Systematic review and meta-analysis of postoperative pancreatic fistula rates using the updated 2016 International Study Group Pancreatic Fistula definition in patients undergoing pancreatic resection with soft and hard pancreatic texture","volume":"20","author":"D Eshmuminov","year":"2018","journal-title":"HPB (Oxford)"},{"issue":"13","key":"pone.0327949.ref005","doi-asserted-by":"crossref","first-page":"8309","DOI":"10.1245\/s10434-021-10292-8","article-title":"More is More? 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