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

T. F. Stoop; L. W. F. Seelen; F. R. van 't Land; A. C. van der Hout; J. C. M. Scheepens; M. Ali; A. M. Stiggelbout; B. M. van der Kolk; B. A. Bonsing; D. J. Lips; D. J. A. de Groot; E. van Veldhuisen; E. D. Kerver; E. R. Manusama; F. Daams; G. Kazemier; G. A. Cirkel; G. van Tienhoven; G. A. Patijn; H. N. Lelieveld-Rier; I. H. de Hingh; I. E. G. van Hellemond; J. H. Wijsman; J. I. Erdmann; J. S. D. Mieog; J. de Vos-Geelen; J. W. B. de Groot; K. R. D. Lutchman; L. J. Mekenkamp; L. W. Kranenburg; L. P. M. Beuk; M. W. Nijkamp; M. den Dulk; M. B. Polee; M. Y. V. Homs; M. L. Wumkes; M. W. J. Stommel; O. R. Busch; R. F. de Wilde; R. T. Theijse; S. A. C. Luelmo; S. Festen; T. L. Bollen; U. P. Neumann; V. E. de Meijer; W. A. Draaisma; B. Groot Koerkamp; I. Q. Molenaar; C. L. Wolfgang; M. Del Chiaro; D.E. Besselink; Et al.

doi:10.1186/s12885-025-13554-w

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

T. F. Stoop, L. W. F. Seelen, F. R. van 't Land, A. C. van der Hout, J. C. M. Scheepens, M. Ali, A. M. Stiggelbout, B. M. van der Kolk, B. A. Bonsing, D. J. Lips, D. J. A. de Groot, E. van Veldhuisen, E. D. Kerver, E. R. Manusama, F. Daams, G. Kazemier, G. A. Cirkel, G. van Tienhoven, G. A. Patijn, H. N. Lelieveld-RierI. H. de Hingh, I. E. G. van Hellemond, J. H. Wijsman, J. I. Erdmann, J. S. D. Mieog, J. de Vos-Geelen, J. W. B. de Groot, K. R. D. Lutchman, L. J. Mekenkamp, L. W. Kranenburg, L. P. M. Beuk, M. W. Nijkamp, M. den Dulk, M. B. Polee, M. Y. V. Homs, M. L. Wumkes, M. W. J. Stommel, O. R. Busch, R. F. de Wilde, R. T. Theijse, S. A. C. Luelmo, S. Festen, T. L. Bollen, U. P. Neumann, V. E. de Meijer, W. A. Draaisma, B. Groot Koerkamp, I. Q. Molenaar, C. L. Wolfgang, M. Del Chiaro, D.E. Besselink^*, Et al.

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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 degrees and/or portomesenteric venous > 270 degrees 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.

Original language	English
Article number	299
Number of pages	12
Journal	BMC Cancer
Volume	25
Issue number	1
DOIs	https://doi.org/10.1186/s12885-025-13554-w
Publication status	Published - 19 Feb 2025

Keywords

Locally advanced pancreatic cancer
Induction therapy
Surgery
Implementation program
The Netherlands
SURGERY
DEFINITION
CLASSIFICATION
GEMCITABINE
STRATEGIES
FOLFIRINOX
CONSENSUS
RESECTION
SURVIVAL
CRITERIA

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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., ... Et al. (2025). Nationwide implementation of the international multidisciplinary best-practice for locally advanced pancreatic cancer (PREOPANC-4): study protocol. BMC Cancer, 25(1), Article 299. https://doi.org/10.1186/s12885-025-13554-w

@article{a20aff6caaab453995177dc7c5944e29,

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

abstract = "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 degrees and/or portomesenteric venous > 270 degrees 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.",

keywords = "Locally advanced pancreatic cancer, Induction therapy, Surgery, Implementation program, The Netherlands, SURGERY, DEFINITION, CLASSIFICATION, GEMCITABINE, STRATEGIES, FOLFIRINOX, CONSENSUS, RESECTION, SURVIVAL, CRITERIA",

author = "Stoop, {T. F.} and Seelen, {L. W. F.} and {van 't Land}, {F. R.} and {van der Hout}, {A. C.} and Scheepens, {J. C. M.} and M. Ali and Stiggelbout, {A. M.} and {van der Kolk}, {B. M.} and Bonsing, {B. A.} and Lips, {D. J.} and {de Groot}, {D. J. A.} and {van Veldhuisen}, E. and Kerver, {E. D.} and Manusama, {E. R.} and F. Daams and G. Kazemier and Cirkel, {G. A.} and {van Tienhoven}, G. and Patijn, {G. A.} and Lelieveld-Rier, {H. N.} and {de Hingh}, {I. H.} and {van Hellemond}, {I. E. G.} and Wijsman, {J. H.} and Erdmann, {J. I.} and Mieog, {J. S. D.} and {de Vos-Geelen}, J. and {de Groot}, {J. W. B.} and Lutchman, {K. R. D.} and Mekenkamp, {L. J.} and Kranenburg, {L. W.} and Beuk, {L. P. M.} and Nijkamp, {M. W.} and {den Dulk}, M. and Polee, {M. B.} and Homs, {M. Y. V.} and Wumkes, {M. L.} and Stommel, {M. W. J.} and Busch, {O. R.} and {de Wilde}, {R. F.} and Theijse, {R. T.} and Luelmo, {S. A. C.} and S. Festen and Bollen, {T. L.} and Neumann, {U. P.} and {de Meijer}, {V. E.} and Draaisma, {W. A.} and Koerkamp, {B. Groot} and Molenaar, {I. Q.} and Wolfgang, {C. L.} and {Del Chiaro}, M. and D.E. Besselink and {Et al.}",

year = "2025",

month = feb,

day = "19",

doi = "10.1186/s12885-025-13554-w",

language = "English",

volume = "25",

journal = "BMC Cancer",

issn = "1471-2407",

publisher = "BioMed Central Ltd",

number = "1",

}

Stoop, TF, Seelen, LWF, van 't Land, FR, van der Hout, AC, Scheepens, JCM, Ali, M, Stiggelbout, AM, van der Kolk, BM, Bonsing, BA, Lips, DJ, de Groot, DJA, van Veldhuisen, E, Kerver, ED, Manusama, ER, Daams, F, Kazemier, G, Cirkel, GA, van Tienhoven, G, Patijn, GA, Lelieveld-Rier, HN, de Hingh, IH, van Hellemond, IEG, Wijsman, JH, Erdmann, JI, Mieog, JSD, de Vos-Geelen, J, de Groot, JWB, Lutchman, KRD, Mekenkamp, LJ, Kranenburg, LW, Beuk, LPM, Nijkamp, MW, den Dulk, M, Polee, MB, Homs, MYV, Wumkes, ML, Stommel, MWJ, Busch, OR, de Wilde, RF, Theijse, RT, Luelmo, SAC, Festen, S, Bollen, TL, Neumann, UP, de Meijer, VE, Draaisma, WA, Koerkamp, BG, Molenaar, IQ, Wolfgang, CL, Del Chiaro, M, Besselink, DE & Et al. 2025, 'Nationwide implementation of the international multidisciplinary best-practice for locally advanced pancreatic cancer (PREOPANC-4): study protocol', BMC Cancer, vol. 25, no. 1, 299. https://doi.org/10.1186/s12885-025-13554-w

TY - JOUR

T1 - Nationwide implementation of the international multidisciplinary best-practice for locally advanced pancreatic cancer (PREOPANC-4)

T2 - study protocol

AU - Stoop, T. F.

AU - Seelen, L. W. F.

AU - van 't Land, F. R.

AU - van der Hout, A. C.

AU - Scheepens, J. C. M.

AU - Ali, M.

AU - Stiggelbout, A. M.

AU - van der Kolk, B. M.

AU - Bonsing, B. A.

AU - Lips, D. J.

AU - de Groot, D. J. A.

AU - van Veldhuisen, E.

AU - Kerver, E. D.

AU - Manusama, E. R.

AU - Daams, F.

AU - Kazemier, G.

AU - Cirkel, G. A.

AU - van Tienhoven, G.

AU - Patijn, G. A.

AU - Lelieveld-Rier, H. N.

AU - de Hingh, I. H.

AU - van Hellemond, I. E. G.

AU - Wijsman, J. H.

AU - Erdmann, J. I.

AU - Mieog, J. S. D.

AU - de Vos-Geelen, J.

AU - de Groot, J. W. B.

AU - Lutchman, K. R. D.

AU - Mekenkamp, L. J.

AU - Kranenburg, L. W.

AU - Beuk, L. P. M.

AU - Nijkamp, M. W.

AU - den Dulk, M.

AU - Polee, M. B.

AU - Homs, M. Y. V.

AU - Wumkes, M. L.

AU - Stommel, M. W. J.

AU - Busch, O. R.

AU - de Wilde, R. F.

AU - Theijse, R. T.

AU - Luelmo, S. A. C.

AU - Festen, S.

AU - Bollen, T. L.

AU - Neumann, U. P.

AU - de Meijer, V. E.

AU - Draaisma, W. A.

AU - Koerkamp, B. Groot

AU - Molenaar, I. Q.

AU - Wolfgang, C. L.

AU - Del Chiaro, M.

AU - Besselink, D.E.

AU - Et al.

PY - 2025/2/19

Y1 - 2025/2/19

N2 - 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 degrees and/or portomesenteric venous > 270 degrees 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.

AB - 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 degrees and/or portomesenteric venous > 270 degrees 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.

KW - Locally advanced pancreatic cancer

KW - Induction therapy

KW - Surgery

KW - Implementation program

KW - The Netherlands

KW - SURGERY

KW - DEFINITION

KW - CLASSIFICATION

KW - GEMCITABINE

KW - STRATEGIES

KW - FOLFIRINOX

KW - CONSENSUS

KW - RESECTION

KW - SURVIVAL

KW - CRITERIA

U2 - 10.1186/s12885-025-13554-w

DO - 10.1186/s12885-025-13554-w

M3 - Article

SN - 1471-2407

VL - 25

JO - BMC Cancer

JF - BMC Cancer

IS - 1

M1 - 299

ER -

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

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Keywords

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