Hempel Sebastian, Kolbinger Fiona R, Oehme Florian, Radulova-Mauersberger Olga, Schmid Janine, Schubert Undine, Schepp Florian, Bornstein Stefan, Korn Sandra, Trips Evelyn, Weitz Jürgen, Distler Marius, Ludwig Barbara
Department of Visceral, Thoracic and Vascular Surgery, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
National Center for Tumor Diseases (NCT/UCC), Dresden, Germany.
PLoS One. 2025 Jul 28;20(7):e0327949. doi: 10.1371/journal.pone.0327949. eCollection 2025.
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.
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. 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.
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.
This study was registered on ClinicalTrials.gov (NCT05843877) on February 27, 2023 and EudraCT (2023-507773-17-00) on April 18, 2024.
胰腺手术仍伴有较高的发病率。具有术后胰瘘（POPF）高风险特征的胰十二指肠切除术（PD）可能会延迟或阻碍辅助治疗的实施。全胰切除术（TP）可预防与POPF相关的并发症，但意味着永久性外分泌和内分泌功能不全。胰岛自体移植（IAT）有可能补偿内分泌功能。
XANDTX是一项单中心随机对照试验，比较高危PD与TP以及在壶腹周围癌患者中同时进行IAT的效果。在筛选合格并获得知情同意后，共32例成年患者将在术中按1:1的比例随机分组。主要假设是，TP联合IAT可预防与POPF相关的并发症，并导致辅助治疗开始时间缩短和辅助治疗总体给药率更高。次要终点包括围手术期发病率和死亡率、代谢结果、生活质量（QoL）和肿瘤学长期结果。每位患者将接受5年的随访。
XANDTX试验旨在提供全胰切除术联合胰岛自体移植在可切除壶腹周围癌治疗中的手术和肿瘤学可行性及安全性数据。研究结果将为进一步的验证性对照研究奠定基础。
本研究于2023年2月27日在ClinicalTrials.gov（NCT05843877）注册，并于2024年4月18日在EudraCT（2023-507773-17-00）注册。
