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

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.

SUBMITTER: Brenkman HJF

PROVIDER: S-EPMC5910577 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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

Brenkman H J F HJF Gertsen E C EC Vegt E E van Hillegersberg R R van Berge Henegouwen M I MI Gisbertz S S SS Luyer M D P MDP Nieuwenhuijzen G A P GAP van Lanschot J J B JJB Lagarde S M SM de Steur W O WO Hartgrink H H HH Stoot J H M B JHMB Hulsewe K W E KWE Spillenaar Bilgen E J EJ van Det M J MJ Kouwenhoven E A EA van der Peet D L DL Daams F F van Sandick J W JW van Grieken N C T NCT Heisterkamp J J van Etten B B Haveman J W JW Pierie J P JP Jonker F F Thijssen A Y AY Belt E J T EJT van Duijvendijk P P Wassenaar E E van Laarhoven H W M HWM Wessels F J FJ Haj Mohammad N N van Stel H F HF Frederix G W J GWJ Siersema P D PD Ruurda J P JP

BMC cancer 20180420 1

<h4>Background</h4>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.<h4>Methods</h4>This prospe ...[more]

PMID: 29678145

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Project description:BackgroundDespite guidelines recommending diagnostic laparoscopy in patients with gastric cancer, implementation is low. We aimed to explore trends in the use of laparoscopy for staging of gastric cancer in Alberta, Canada, determine the rate of positive findings and identify factors predictive of positive staging laparoscopy (SL) findings in this patient population.MethodsIn August 2018, we sent a survey to all general surgeons in Alberta who were members of the Alberta Association of General Surgeons to identify those treating gastric cancer. The survey inquired about type of practice (academic or community), gastric cancer case volume, routine versus selective use of SL and, if selective use of SL, criteria used to select cases. Participants were also asked to provide data from their SL cases from July 2007 to February 2019. We double-checked surgeon records with chart review. The primary outcome was evidence of metastatic disease on SL or cytologic examination or both. We performed logistic regression analysis to identify factors predictive of positive laparoscopy findings.ResultsThe survey was completed by 41 of 127 surgeons (response rate 32.3%). We reviewed 116 cases from 5 surgeons at 4 centres. Gross metastatic disease or positive findings on cytologic examination or both were identified in 37 patients (31.9%). On univariate analysis, the following were associated with an increased risk of identification of metastatic disease at laparoscopy: visualization of the primary tumour on computed tomography (CT) (odds ratio [OR] 9.8, 95% confidence interval [CI] 1.2-76.5), presence of abdominal lymphadenopathy greater than 1 cm (OR 2.4, 95% CI 1.1-5.4) and presence of ascites (OR 19.1, 95% CI 2.2-161.8). Visualization of the primary tumour on CT (OR 8.4, 95% CI 1.0-68.3) and the presence of ascites (OR 15.9, 95% CI 1.8-137.0) remained statistically significant predictors on multivariate analysis.ConclusionMetastatic disease was identified at SL in almost one-third of cases, which suggests that SL should still be used routinely in gastric cancer staging in Canadian centres. Our study identified several preoperative imaging findings associated with evidence of metastatic disease on laparoscopy; however, further studies are needed to establish robust predictors of positive findings before advocating for a selective SL approach.

Project description:BackgroundEnhanced recovery after surgery (ERAS) has been successfully applied in general surgery, especially in colorectal resection. However, the effect of ERAS in gastric cancer resection in current studies are inconsistent and most of which were single center retrospective ones. Thus, our study was aimed to evaluate the application of laparoscopy in ERAS for gastric cancer based on Chinese multicenter data.MethodsThe clinical and pathological data of patients who underwent radical gastric cancer resection at three Chinese medical centers between January, 2015 and December, 2017 were retrospectively analyzed. The current application of laparoscopy in ERAS for gastric cancer was evaluated.ResultsA total of 1,434 patients were involved in the final analysis. The operation time was 265.7±79.1 min, blood loss was 200 [5-1,300] mL, and the number of lymph nodes dissected was 26.4±12.9. Time to first ambulation, flatus, and liquid food intake were 2.1±1.3, 4.4±2.7, and 6.1±3.6 days, respectively, and postoperative hospital stay was 9.0±1.5 days. The incidence of postoperative complications, Clavien-Dindo score ≥ II, was 10.0%, and the rate of readmission within 30 days of discharge was 1.4%. Of the patients who underwent total gastrectomy, those in the laparoscopic group had a higher number of lymph nodes retrieved than those in the open group (P<0.05), and also had earlier ambulation, oral intake and first flatus, as well as a shorter postoperative hospital stay time than the open group. There were no significant differences in intraoperative blood loss or postoperative complications between the two groups (P>0.05). Of the patients who underwent distal gastrectomy, the laparoscopic group had a lower volume of blood loss, shorter postoperative hospital stay time, and earlier ambulation, oral intake, and first flatus than the open group, and had a similar number of lymph nodes dissected compared to the open group (P>0.05).ConclusionsLaparoscopic surgery combined with ERAS can shorten the time to early ambulation, oral intake, and first flatus, and shorten the length of hospital stay. Laparoscopic surgery can achieve the same oncological outcomes as open surgery and is safe and feasible without increasing the incidence of postoperative complications.

Dataset Information

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

Publications

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

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