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Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Study protocol

Evaluation of PET and laparoscopy in STagIng advanced gastric cancer: a multicenter prospective study (PLASTIC-study)

Authors: H. J. F. Brenkman, E. C. Gertsen, E. Vegt, R. van Hillegersberg, M. I. van Berge Henegouwen, S. S. Gisbertz, M. D. P. Luyer, G. A. P. Nieuwenhuijzen, J. J. B. van Lanschot, S. M. Lagarde, W. O. de Steur, H. H. Hartgrink, J. H. M. B. Stoot, K. W. E. Hulsewe, E. J. Spillenaar Bilgen, M. J. van Det, E. A. Kouwenhoven, D. L. van der Peet, F. Daams, J. W. van Sandick, N. C. T. van Grieken, J. Heisterkamp, B. van Etten, J. W. Haveman, J. P. Pierie, F. Jonker, A. Y. Thijssen, E. J. T. Belt, P. van Duijvendijk, E. Wassenaar, H. W. M. van Laarhoven, F. J. Wessels, N. Haj Mohammad, H. F. van Stel, G. W. J. Frederix, P. D. Siersema, J. P. Ruurda, on behalf of the PLASTIC Study Group

Published in: BMC Cancer | Issue 1/2018

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Abstract

Background

Initial staging of gastric cancer consists of computed tomography (CT) and gastroscopy. In locally advanced (cT3–4) gastric cancer, fluorodeoxyglucose positron emission tomography with CT (FDG-PET/CT or PET) and staging laparoscopy (SL) may have a role in staging, but evidence is scarce. The aim of this study is to evaluate the impact and cost-effectiveness of PET and SL in addition to initial staging in patients with locally advanced gastric cancer.

Methods

This prospective observational cohort study will include all patients with a surgically resectable, advanced gastric adenocarcinoma (cT3–4b, N0–3, M0), that are scheduled for treatment with curative intent after initial staging with gastroscopy and CT. The modalities to be investigated in this study is the addition of PET and SL. The primary outcome of this study is the proportion of patients in whom the PET or SL lead to a change in treatment strategy. Secondary outcome parameters are: diagnostic performance, morbidity and mortality, quality of life, and cost-effectiveness of these additional diagnostic modalities. The study recently started in August 2017 with a duration of 36 months. At least 239 patients need to be included in this study to demonstrate that the diagnostic modalities are break-even. Based on the annual number of gastrectomies in the participating centers, it is estimated that approximately 543 patients are included in this study.

Discussion

In this study, it is hypothesized that performing PET and SL for locally advanced gastric adenocarcinomas results in a change of treatment strategy in 27% of patients and an annual cost-reduction in the Netherlands of €916.438 in this patient group by reducing futile treatment. The results of this study may be applicable to all countries with comparable treatment algorithms and health care systems.

Trial registration

NCT03208621. This trial was registered prospectively on June 30, 2017.
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Metadata
Title
Evaluation of PET and laparoscopy in STagIng advanced gastric cancer: a multicenter prospective study (PLASTIC-study)
Authors
H. J. F. Brenkman
E. C. Gertsen
E. Vegt
R. van Hillegersberg
M. I. van Berge Henegouwen
S. S. Gisbertz
M. D. P. Luyer
G. A. P. Nieuwenhuijzen
J. J. B. van Lanschot
S. M. Lagarde
W. O. de Steur
H. H. Hartgrink
J. H. M. B. Stoot
K. W. E. Hulsewe
E. J. Spillenaar Bilgen
M. J. van Det
E. A. Kouwenhoven
D. L. van der Peet
F. Daams
J. W. van Sandick
N. C. T. van Grieken
J. Heisterkamp
B. van Etten
J. W. Haveman
J. P. Pierie
F. Jonker
A. Y. Thijssen
E. J. T. Belt
P. van Duijvendijk
E. Wassenaar
H. W. M. van Laarhoven
F. J. Wessels
N. Haj Mohammad
H. F. van Stel
G. W. J. Frederix
P. D. Siersema
J. P. Ruurda
on behalf of the PLASTIC Study Group
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4367-9

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