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

Hylke J F Brenkman ,Nadia Haj Mohammad ,Freek Daams ,Geert Frederix ,Suzanne S Gisbertz ,Eelco B Wassenaar ,Grard A P Nieuwenhuijzen ,J.j.b Van Lanschot ,Sjoerd M Lagarde ,Erik Vegt ,Peter Van Duijvendijk ,Karel W E Hulsewé ,Ewout A Kouwenhoven ,Nicole C.t Van Grieken ,Henk H Hartgrink ,Jean-Pierre E N Pierie ,Wobbe O De Steur ,Joos Heisterkamp ,Donald L Van Der Peet ,Jan Willem Haveman ,Henk F Van Stel ,Richard Van Hillegersberg ,Frank J Wessels ,Annemieke Y Thijssen ,Boudewijn Van Etten ,Marc J Van Det ,Frederik H.w Jonker ,Jan H.m.b Stoot ,Ernst Jan Spillenaar Bilgen ,Emma C Gertsen ,Hanneke W M Van Laarhoven ,Misha Luyer ,Johanna W Van Sandick ,Peter D Siersema ,Eric Belt ,Mark I Van Berge Henegouwen ,Jelle P Ruurda

doi:10.1186/s12885-018-4367-9

Abstract

BackgroundInitial 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.MethodsThis 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.DiscussionIn 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 registrationNCT03208621. This trial was registered prospectively on June 30, 2017.

Highlights

Initial staging of gastric cancer consists of computed tomography (CT) and gastroscopy
Two undesirable situations may occur in practice: 1. Unexpected intraoperative peritoneal metastases or local tumor irresectability are found at the onset of gastrectomy
Aim of the study The aim of this study is to evaluate the clinical impact and cost-effectiveness of positron emission tomography with CT (PET) and staging laparoscopy (SL) in addition to initial staging by CT and gastroscopy in patients with locally advanced gastric cancer

Summary

Introduction

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. In Western countries, curative treatment consists of gastrectomy with perioperative chemotherapy [2,3,4]. The prognosis of patients who undergo curative treatment remains relatively poor, with a 5-year overall survival rate of 20–40%. Computed tomography (CT) of the thorax and abdomen is performed to detect metastases and evaluate local resectability. Unexpected intraoperative peritoneal metastases or local tumor irresectability are found at the onset of gastrectomy Two undesirable situations may occur in practice: 1. Unexpected intraoperative peritoneal metastases or local tumor irresectability are found at the onset of gastrectomy

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