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

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.

Staging laparoscopy in gastric cancer surgery. A population-based cohort study in patients undergoing gastrectomy with curative intent

“…However, this study is insightful, by showing clearly that there is still a high rate of avoidable surgery after a staging laparoscopy. The current prospective PLASTIC study, that evaluates the impact and cost-effectiveness of PET-CT and staging laparoscopy, may confirm our study results in the near future [6].…”

“…However, studies have indicated that the sensitivity of CT to detect M1 disease or T4b ranges between 22-33% and 5e69%, respectively [8e11]. Hence, patients with advanced gastric cancer have a high chance of unexpected intraoperative distant metastases or local non-resectability, detected at onset of gastrectomy with curative intent [6].…”

Evaluation of the Implementation of FDG-PET/CT and Staging Laparoscopy for Gastric Cancer in The Netherlands

“…15 Interventions to promote the implementation of research findings include educational outreach visits. 16 As part of the PLASTIC study, 17 a prospective observational cohort study in The Netherlands that evaluated the impact and cost effectiveness of FDG-PET/CT and SL in addition to initial staging (CT and gastroscopy) in patients with locally advanced gastric cancer, these educational visits started in August 2017. Other factors that have been reported to contribute to slow implementation are the qualities of the guidelines (such as compatibility with existing beliefs and values, or complexity), characteristics of the health care practice setting (including legal and financial aspects), and characteristics of the healthcare professional (e.g.…”

“…6,23 For these reasons, the results of the PLASTIC trial, also evaluating histopathology data, are awaited. 17…”

Gastric cancer and image-derived quantitative parameters: Part 2—a critical review of DCE-MRI and 18F-FDG PET/CT findings

“…The most useful techniques are endoscopic ultrasound, computed tomography (CT), magnetic resonance imaging (MRI) and 18 F-fluorodeoxyglucose positron emission tomography ( 18 F-FDG PET)/CT. At this regard, the PLASTIC trial [5] is an ongoing study that will evaluate the impact and cost-effectiveness of PET and staging laparoscopy in addition to initial staging in patients with locally advanced GC.…”