Stoop T F, Seelen L W F, van 't Land F R, van der Hout A C, Scheepens J C M, Ali M, Stiggelbout A M, van der Kolk B M, Bonsing B A, Lips D J, de Groot D J A, van Veldhuisen E, Kerver E D, Manusama E R, Daams F, Kazemier G, Cirkel G A, van Tienhoven G, Patijn G A, Lelieveld-Rier H N, de Hingh I H, van Hellemond I E G, Wijsman J H, Erdmann J I, Mieog J S D, de Vos-Geelen J, de Groot J W B, Lutchman K R D, Mekenkamp L J, Kranenburg L W, Beuk L P M, Nijkamp M W, den Dulk M, Polée M B, Homs M Y V, Wumkes M L, Stommel M W J, Busch O R, de Wilde R F, Theijse R T, Luelmo S A C, Festen S, Bollen T L, Neumann U P, de Meijer V E, Draaisma W A, Groot Koerkamp B, Molenaar I Q, Wolfgang C L, Del Chiaro M, Katz M G H, Hackert T, Rietjens J A C, Wilmink J W, van Santvoort H C, van Eijck C H J, Besselink M G
Amsterdam UMC, Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands.
Cancer Center Amsterdam, Amsterdam, the Netherlands.
BMC Cancer. 2025 Feb 19;25(1):299. doi: 10.1186/s12885-025-13554-w.
The introduction of (m)FOLFIRINOX and gemcitabine-nab-paclitaxel has changed the perspective for patients with locally advanced pancreatic cancer (LAPC). Consequently, in experienced centres 23% of patients with LAPC undergo a resection with 5-year overall survival (OS) rates of up to 25%. In the Netherlands, the nationwide resection rate for LAPC remains low at 8%. The PREOPANC-4 program aims for a nationwide implementation of the international multidisciplinary best-practice to improve patient outcome.
Nationwide program implementing the international multidisciplinary best-practice for LAPC. In the training phase, multidisciplinary and surgical webinars are given by 4 international experts, leading to a clinical protocol, followed by surgical off-site and on-site proctoring sessions. In the implementation phase, the clinical protocol will be implemented in all centres, including a nationwide expert panel (2022-2024). Healthcare professionals will be trained in shared decision-making. Consecutive patients diagnosed with pathology-proven LAPC (i.e., arterial involvement > 90° and/or portomesenteric venous > 270° involvement or occlusion [DPCG criteria]) are eligible. Primary outcomes are median and 5-year OS from diagnosis, resection rate, in-hospital/30-day mortality and major morbidity (i.e., Clavien-Dindo grade ≥ IIIa), and radical resection (R0) rate. Secondary outcomes include quality of life, functioning, side effects, and patients' healthcare satisfaction in all included patients. Outcomes will be compared with patients with borderline resectable pancreatic cancer (BRPC) treated with neoadjuvant FOLFIRINOX in the PREOPANC-2 trial (EudraCT: 2017-002036-17) and a historical cohort of patients with LAPC from the PACAP registry (NCT03513705). The existing prospective LAPC Registry and PACAP PROMs (NCT03513705) will be used for data collection. In qualitative interviews, treatment preferences, values, and experiences of LAPC patients, their relatives, and healthcare professionals will be assessed for the development of shared decision-making supportive tools. It is hypothesized that the program will double the nationwide LAPC resection rate to 16% with major morbidity < 50% and mortality ≤ 5%, and OS following resection similar to that observed in patients with BRPC.
The PREOPANC-4 program aims to safely implement the international multidisciplinary best-practice for LAPC leading to benchmark outcomes for both short-term morbidity, mortality, and OS.
PREOPANC-4 program was registered at ClinicalTrials.gov (NCT05524090) on September 1, 2022.
（m）FOLFIRINOX方案和吉西他滨纳米白蛋白紫杉醇的引入改变了局部晚期胰腺癌（LAPC）患者的治疗前景。因此，在经验丰富的中心，23%的LAPC患者接受了手术切除，5年总生存率（OS）高达25%。在荷兰，LAPC的全国手术切除率仍然较低，为8%。PREOPANC-4项目旨在在全国范围内实施国际多学科最佳实践，以改善患者预后。
在全国范围内实施LAPC国际多学科最佳实践的项目。在培训阶段，4位国际专家举办多学科和外科网络研讨会，形成临床方案，随后进行手术场外和现场指导。在实施阶段，临床方案将在所有中心实施，包括一个全国专家小组（2022-2024年）。医疗保健专业人员将接受共同决策方面的培训。连续诊断为病理证实的LAPC患者（即动脉受累>90°和/或门静脉肠系膜静脉受累>270°或闭塞[DPCG标准]）符合条件。主要结局为诊断后的中位生存期和5年OS、切除率、住院/30天死亡率和严重并发症（即Clavien-Dindo分级≥IIIa级）以及根治性切除（R0）率。次要结局包括所有纳入患者的生活质量、功能、副作用和患者对医疗保健的满意度。结局将与PREOPANC-2试验（EudraCT：2017-002036-17）中接受新辅助FOLFIRINOX治疗的临界可切除胰腺癌（BRPC）患者以及PACAP注册中心（NCT03513705）的LAPC患者历史队列进行比较。现有的前瞻性LAPC注册中心和PACAP患者报告结局测量（NCT03513705）将用于数据收集。在定性访谈中，将评估LAPC患者、其亲属和医疗保健专业人员的治疗偏好、价值观和经历，以开发共同决策支持工具。假设该项目将使全国LAPC切除率提高一倍至16%，严重并发症<50%，死亡率≤5%，切除后的OS与BRPC患者相似。
PREOPANC-4项目旨在安全实施LAPC国际多学科最佳实践，以实现短期并发症、死亡率和OS的基准结局。
PREOPANC-4项目于2022年9月1日在ClinicalTrials.gov（NCT05524090）注册。
