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Nationwide implementation of the international multidisciplinary best-practice for locally advanced pancreatic cancer (PREOPANC-4): study protocol.

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  • معلومة اضافية
    • Corporate Authors:
      Dutch Pancreatic Cancer Group
    • المصدر:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2407 (Electronic) Linking ISSN: 14712407 NLM ISO Abbreviation: BMC Cancer Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: London : BioMed Central, [2001-
    • الموضوع:
      Pancreatic Neoplasms*/pathology ; Pancreatic Neoplasms*/therapy ; Pancreatic Neoplasms*/mortality ; Pancreatic Neoplasms*/drug therapy ; Antineoplastic Combined Chemotherapy Protocols*/therapeutic use; Humans ; Netherlands ; Irinotecan/therapeutic use ; Oxaliplatin/therapeutic use ; Oxaliplatin/administration & dosage ; Fluorouracil/therapeutic use ; Gemcitabine ; Deoxycytidine/analogs & derivatives ; Deoxycytidine/administration & dosage ; Paclitaxel/administration & dosage ; Quality of Life ; Pancreatectomy ; Albumins ; Leucovorin
    • نبذة مختصرة :
      Background: 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.
      Methods: 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.
      Discussion: 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.
      Trial Registration: PREOPANC-4 program was registered at ClinicalTrials.gov (NCT05524090) on September 1, 2022.
      (© 2025. The Author(s).)
    • نبذة مختصرة :
      Declarations. Ethical approval and consent to participate: The Medical Ethical Committee from the Amsterdam UMC (location Academic Medical Center) has assessed the study protocol (excluding the section about shared decision-making training and the qualitative interview study) and concluded that the Medical Research Involving Human Subjects Act (WMO) does NOT apply to the PREOPANC-4 program (W21_487 # 21.541). The local Medical Ethical Committee from each participating centre has approved their participation. Consent for publication: The manuscript contains no individual person’s data in any form. Consent is not applicable. Competing interests: (1) T.F. Stoop is granted by the Cultuurfonds (Jan de Ruijsscher / Pia Huisman Fonds). (2) M. Del Chiaro has been awarded with an industry grant (Haemonetics, Inc) to conduct a multicentre study to evaluate the prognostic implications of TEG in pancreatic cancer. (3) M. Del Chiaro is co-principal investigator of a Boston Scientific sponsored international multicentre study on the use of intraoperative pancreatoscopy of patients with IPMN. (4) M.G. Besselink has received grants from Ethicon, Medtronic, Intuitive Surgical, Oncosil and is a proctor for Intuitive Surgical. (5) J.W. Wilmink has received grants from MSD, Nordic and Servier and reports an advisory role for MSD, Astra Zeneca and Servier.
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    • Grant Information:
      #2021-2 / 14106 KWF Kankerbestrijding; #2022-003 / WOO 21-02 Deltaplan Alvleesklierkanker/Maag-Lever-Darm Stichting
    • Contributed Indexing:
      Investigator: A Bruynzeel; A Vlijm; A van Asseldonk; B Zonderhuis; AA Javed; A Sterk; A Schoorlemmer; A Stam; CY Nio; E van Alphen; HWM van Laarhoven; H van Veenendaal; I Griffioen; IF Rompen; JM Klaase; M Los; MFMA Marting; MSL Liem; J Peters; LJ Peters; L Garms; M Walma; LHJ Brada; M Seijbel; ND Hildebrand; N Michiels; R Bax; RM van Dam; S Achten; S Bouwense; S Augustinus; S Rötgerink; TW van Ravens; VB Nieuwenhuijs; WW Te Riele
      Keywords: Implementation program; Induction therapy; Locally advanced pancreatic cancer; Surgery; The Netherlands
    • Molecular Sequence:
      ClinicalTrials.gov NCT05524090
    • الرقم المعرف:
      7673326042 (Irinotecan)
      04ZR38536J (Oxaliplatin)
      U3P01618RT (Fluorouracil)
      0 (Gemcitabine)
      0W860991D6 (Deoxycytidine)
      0 (folfirinox)
      0 (130-nm albumin-bound paclitaxel)
      P88XT4IS4D (Paclitaxel)
      0 (Albumins)
      Q573I9DVLP (Leucovorin)
    • الموضوع:
      Date Created: 20250219 Date Completed: 20250508 Latest Revision: 20250516
    • الموضوع:
      20250519
    • الرقم المعرف:
      PMC11841322
    • الرقم المعرف:
      10.1186/s12885-025-13554-w
    • الرقم المعرف:
      39972248