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Background: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18 F-fluorodeoxyglucose positron emission tomography/computed tomography ( 18F FDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging., Materials and Methods: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18F FDG-PET/CT first, then SL, (2) SL only, (3) 18F FDG-PET/CT only, and (4) neither SL nor 18F FDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18F FDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18F FDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations)., Results: 18F FDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18F FDG-PET/CT to SL increased costs by €1058 per patient; IQR €870-1253 in the sensitivity analysis., Conclusions: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18F FDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs., Trial Registration: NCT03208621. This trial was registered prospectively on 30-06-2017., (© 2024. The Author(s).)

Background: The oncological efficacy and safety of laparoscopic gastrectomy are under debate for the Western population with predominantly advanced gastric cancer undergoing multimodality treatment., Methods: In 10 experienced upper GI centers in the Netherlands, patients with resectable (cT1-4aN0-3bM0) gastric adenocarcinoma were randomly assigned to either laparoscopic or open gastrectomy. No masking was performed. The primary outcome was hospital stay. Analyses were performed by intention to treat. It was hypothesized that laparoscopic gastrectomy leads to shorter hospital stay, less postoperative complications, and equal oncological outcomes., Results: Between 2015 and 2018, a total of 227 patients were randomly assigned to laparoscopic (n = 115) or open gastrectomy (n = 112). Preoperative chemotherapy was administered to 77 patients (67%) in the laparoscopic group and 87 patients (78%) in the open group. Median hospital stay was 7 days (interquartile range, 5-9) in both groups ( P = .34). Median blood loss was less in the laparoscopic group (150 v 300 mL, P < .001), whereas mean operating time was longer (216 v 182 minutes, P < .001). Both groups did not differ regarding postoperative complications (44% v 42%, P = .91), in-hospital mortality (4% v 7%, P = .40), 30-day readmission rate (9.6% v 9.1%, P = 1.00), R0 resection rate (95% v 95%, P = 1.00), median lymph node yield (29 v 29 nodes, P = .49), 1-year overall survival (76% v 78%, P = .74), and global health-related quality of life up to 1 year postoperatively (mean differences between + 1.5 and + 3.6 on a 1-100 scale; 95% CIs include zero)., Conclusion: Laparoscopic gastrectomy did not lead to a shorter hospital stay in this Western multicenter randomized trial of patients with predominantly advanced gastric cancer. Postoperative complications and oncological efficacy did not differ between laparoscopic gastrectomy and open gastrectomy.

Background: Surgical resection with adequate lymphadenectomy is regarded the only curative option for gastric cancer. Regarding minimally invasive techniques, mainly Asian studies showed comparable oncological and short-term postoperative outcomes. The incidence of gastric cancer is lower in the Western population and patients often present with more advanced stages of disease. Therefore, the reproducibility of these Asian results in the Western population remains to be investigated., Methods: A randomized trial was performed in thirteen hospitals in Europe. Patients with an indication for total gastrectomy who received neoadjuvant chemotherapy were eligible for inclusion and randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG). Primary outcome was oncological safety, measured as the number of resected lymph nodes and radicality. Secondary outcomes were postoperative complications, recovery and 1-year survival., Results: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. The mean number of resected lymph nodes was 43.4 ± 17.3 in OTG and 41.7 ± 16.1 in MITG (p = 0.612). Forty-eight patients in the OTG group had a R0 resection and 44 patients in the MITG group (p = 0.617). One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701). No significant differences were found regarding postoperative complications and recovery., Conclusion: These findings provide evidence that MITG after neoadjuvant therapy is not inferior regarding oncological quality of resection in comparison to OTG in Western patients with resectable gastric cancer. In addition, no differences in postoperative complications and recovery were seen.

Background: Although radical surgery remains the cornerstone of cure in resectable gastric cancer, survival remains poor. Current evidence-based (neo)adjuvant strategies have shown to improve outcome, including perioperative chemotherapy, postoperative chemoradiotherapy and postoperative chemotherapy. However, these regimens suffer from poor patient compliance, particularly in the postoperative phase of treatment. The CRITICS-II trial aims to optimize preoperative treatment by comparing three treatment regimens: (1) chemotherapy, (2) chemotherapy followed by chemoradiotherapy and (3) chemoradiotherapy., Methods: In this multicentre phase II non-comparative study, patients with clinical stage IB-IIIC (TNM 8th edition) resectable gastric adenocarcinoma are randomised between: (1) 4 cycles of docetaxel+oxaliplatin+capecitabine (DOC), (2) 2 cycles of DOC followed by chemoradiotherapy (45Gy in combination with weekly paclitaxel and carboplatin) or (3) chemoradiotherapy. Primary endpoint is event-free survival, 1 year after randomisation (events are local and/or regional recurrence or progression, distant recurrence, or death from any cause). Secondary endpoints include: toxicity, surgical outcomes, percentage radical (R0) resections, pathological tumour response, disease recurrence, overall survival, and health related quality of life. Exploratory endpoints include translational studies on predictive and prognostic biomarkers., Discussion: The aim of this study is to select the most promising among three preoperative treatment arms in patients with resectable gastric adenocarcinoma. This treatment regimen will subsequently be compared with the standard therapy in a phase III trial., Trial Registration: clinicaltrials.gov NCT02931890 ; registered 13 October 2016. Date of first enrolment: 21 December 2017.

Background: Esophageal anastomotic leakage (EAL) is a severe complication following gastric and esophageal surgery for cancer. Several non-modifiable, patient or surgery related risk factors for EAL have been identified, however, the contribution of modifiable intraoperative parameters remains undetermined. This review provides an overview of current literature on potentially modifiable intraoperative risk factors for EAL., Materials and Methods: The PubMed, EMBASE and Cochrane databases were searched by two researchers independently. Clinical studies published in English between 1970 and January 2017 that evaluated the effect of intraoperative parameters on the development of EAL were included. Levels of evidence as defined by the Centre of Evidence Based Medicine (CEBM) were assigned to the studies., Results: A total of 25 articles were included in the final analysis. These articles show evidence that anemia, increased amount of blood loss, low pH and high pCO2 values, prolonged duration of procedure and lack of surgical experience independently increase the risk of EAL. Supplemental oxygen therapy, epidural analgesia and selective digestive decontamination seem to have a beneficial effect. Potential risk factors include blood pressure, requirement of blood products, vasopressor use and glucocorticoid administration, however the results are ambiguous., Conclusion: Apart from fixed surgical and patient related factors, several intraoperative factors that can be modified in clinical practice can influence the risk of developing EAL. More prospective, observational studies are necessary focusing on modifiable intraoperative parameters to assess more evidence and to elucidate optimal values of these factors., (Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.)

Aim: Insight in health-related quality of life (HRQoL) may improve clinical decision making and inform patients about the long-term effects of gastrectomy. This study aimed to evaluate and identify factors associated with HRQoL after gastrectomy., Methods: This cross-sectional study used prospective databases from seven Dutch centers (2001-2015) including patients who underwent gastrectomy for cancer. Between July 2015 and November 2016, European Organization for Research and Treatment of Cancer HRQoL questionnaires QLQ-C30 and QLQ-STO22 were sent to all surviving patients without recurrence. The QLQ-C30 scores were compared to a Dutch reference population using a one-sample t test. Spearman's rank test was used to correlate time after surgery to HRQoL, and multivariable linear regression was performed to identify factors associated with HRQoL., Results: A total of 222 of 274 (81.0%) patients completed the questionnaires. Median follow-up was 29 months (range, 3-171) and 86.9% of patients had a follow-up >1 year. The majority of patients had undergone neoadjuvant treatment (64.4%) and total gastrectomy (52.7%). Minimally invasive gastrectomy (MIG) was performed in 50% of the patients. Compared to the general population, gastrectomy patients scored significantly worse on most functional and symptom scales (p < 0.001) and slightly worse on global HRQoL (78 vs. 74, p = 0.012). Time elapsed since surgery did not correlate with global HRQoL (Spearman's ρ = 0.06, p = 0.384). Distal gastrectomy, neoadjuvant treatment, and MIG were associated with better HRQoL (p < 0.050)., Conclusion: After gastrectomy, patients encounter functional impairments and symptoms, but experience only a slightly impaired global HRQoL. Distal gastrectomy, the ability to receive neoadjuvant treatment, and MIG may be associated with HRQoL benefits.

Objective: Minimally invasive surgical techniques for gastric cancer are gaining more interest worldwide. Several Asian studies have proven the benefits of minimally invasive techniques over the open techniques. Nevertheless, implementation of this technique in Western countries is gradual. The aim of this systematic review is to give insight in the differences in outcomes and patient characteristics in Asian countries in comparison to Western countries., Methodology: An extensive systematic search was conducted using the Medline, Embase, and Cochrane databases. Analysis of the outcomes was performed regarding operative results, postoperative recovery, complications, mortality, lymph node yield, radicality of the resected specimen, and survival. A total of 12 Asian and 8 Western studies were included., Results: Minimally invasive gastrectomy shows faster postoperative recovery, fewer complications, and similar outcomes regarding mortality in both the Eastern and Western studies. However, patient characteristics such as age and BMI differ between these populations. Comparison of overall outcomes in minimally invasive and open procedures between East and West showed differences in complications, mortality, and number of resected lymph nodes in favor of the Asian population., Conclusion: Improved outcomes are observed following minimally invasive gastrectomy in comparison to open procedures in both Western and Asian studies. There are differences in patient characteristics between the Western and Asian populations. Overall outcomes seem to be in favor of the Asian population. These differences may fade with centralization of care for gastric cancer patients in the West and increasing surgical experience.

Background: Survival rates after a total gastrectomy with adequate lymphadenectomy are improving, leading to a shift in outcomes of interest from survival to postoperative outcomes and symptoms. In this systematic review, we investigate gastrointestinal symptoms that occur after a gastrectomy in relation to exocrine pancreatic insufficiency and the effect of pancreatic exocrine enzyme supplementation on these symptoms., Methods: Online databases PubMed, Embase, and Cochrane Library were systematically searched in accordance with the PRISMA guidelines. Studies that researched gastrointestinal symptoms, exocrine pancreatic function, and enzyme supplementation were identified and assessed., Results: The search resulted in a total of 1,023 articles after exclusion of duplicates. After performing a thorough assessment, 4 studies were included for systematic review. Exocrine pancreatic insufficiency was investigated by 2 studies; the results showed a significant decrease of total exocrine pancreatic function of up to 76%. The other 2 studies investigated the effect of pancreatic enzyme supplementation and found minor improvement in fecal consistency and a decrease in high-degree steatorrhea. No differences in individual symptom scores were reported., Conclusion: Gastrointestinal symptoms such as steatorrhea, bloating, and dumping syndrome may be related to exocrine pancreatic function, initiated by total gastrectomy. Treatment with pancreatic enzymes had a minor positive effect on patients. It should be noted that these studies were of a small sample size and low quality. New and larger RCTs are necessary to either prove or disprove the benefit of pancreatic enzyme replacement therapy in the treatment of the gastrointestinal symptoms after total gastrectomy., (© 2017 S. Karger AG, Basel.)

Background: Gastric cancer is responsible for 10 % of all cancer-related deaths worldwide. With improved operative techniques and neo-adjuvant therapy, survival rates are increasing. Outcomes of interest are shifting to quality of life (QOL), with many different tools available. The aim of this study was to assess which patient-reported outcome measures (PROMs) are used to measure QOL after a gastrectomy for cancer., Methods: A comprehensive search was conducted for original articles investigating QOL after gastrectomy. Two authors independently selected relevant articles, conducted clinical appraisal and extracted data (P.J. and J.S.)., Results: Out of 3414 articles, 26 studies were included, including a total of 4690 patients. These studies included ten different PROMs, which could be divided into generic, symptom-specific and disease-specific questionnaires. The EORTC and the FACT questionnaires use an oncological overall QOL module and an organ-specific module. Only one validation study regarding the use of the EORTC after surgery for gastric cancer was available, demonstrating good psychometric properties and clinical validity., Conclusions: A great variety of PROMs are being used in the measurement of QOL after surgery for gastric cancer. A questionnaire with a general module along with a disease-specific module for the assessment of QOL seems most desirable, such as the EORTC and the FACT with their specific modules. Both are developed in different treatment modalities, such as in surgical patients. EORTC is the most widely used questionnaire and therefore allows for comparison of new studies to existing data. Future studies are needed to assess content validity in surgical gastric cancer patients.

Minimally invasive surgical techniques for gastric cancer are gaining more acceptance worldwide as an alternative to open resection. In order to assess the role of minimally invasive and open techniques in total gastrectomy for cancer, a systematic review and meta-analysis was performed. Articles comparing minimally invasive versus open total gastrectomy were reviewed, collected from the Medline, Embase, and Cochrane databases. Two different authors (JS and NW) independently selected and assessed the articles. Outcomes regarding operative results, postoperative recovery, morbidity, mortality, and oncological outcomes were analyzed. Statistical analysis portrayed the weighted mean difference (WMD) with a 95% confidence interval and odds ratio (OR). Out of 1242 papers, 12 studies were selected, including a total of 1360 patients, of which 592 underwent minimally invasive total gastrectomy (MITG). Compared to open total gastrectomy (OTG), MITG showed a longer operation time (WMD: 48.06 min, P < 0.00001), less operative blood loss (WMD: -160.70 mL, P < 0.00001), faster postoperative recovery, measured as shorter time to first flatus (WMD -1.05 days, P < 0.00001), shorter length of hospital stay (WMD: -2.43 days, P = 0.0002), less postoperative complications (OR 0.66, P = 0.02), similar mortality rates (OR 0.60, P = 0.52), and similar rates in lymph node yield (WMD -2.30, P = 0.06). Minimally invasive total gastrectomy showed faster postoperative recovery and less postoperative complications, whereas completeness of the resection was similar in both groups. Duration of surgery was longer in the minimally invasive group. Only comparative non-randomized studies were available, further emphasizing the need for a prospective randomized trial comparing MITG and OTG.

Background: For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy., Methods: The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness., Discussion: In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient., Trial Registration: NCT02248519.

Background: Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less perioperative blood loss and faster patient recovery. It also maintains similar results with regard to tumor resection margins and oncological long-term survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, with a free margin of 5 to 6 cm from the tumor, combined with a lymphadenectomy. The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, it is imperative that a novel surgical technique, such as minimally invasive total gastrectomy, should be non-inferior with regard to radicality of surgery and lymph node yield., Methods/design: The Surgical Techniques, Open versus Minimally invasive gastrectomy After CHemotherapy (STOMACH) study is a randomized, clinical multicenter trial. All adult patients with primary carcinoma of the stomach, in which the tumor is considered surgically resectable (T1-3, N0-1, M0) after neo-adjuvant chemotherapy, are eligible for inclusion and randomization. The primary endpoint is quality of oncological resection, measured by radicality of surgery and number of retrieved lymph nodes. The pathologist is blinded towards patient allocation. Secondary outcomes include patient-reported outcomes measures (PROMs) regarding quality of life, postoperative complications and cost-effectiveness. Based on a non-inferiority model for lymph node yield, with an average lymph node yield of 20, a non-inferiority margin of -4 and a 90% power to detect non-inferiority, a total of 168 patients are to be included., Discussion: The STOMACH trial is a prospective, multicenter, parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy: the conventional 'open' approach or minimally invasive total gastrectomy., Trial Registration: This trial was registered on 28 April 2014 at Clinicaltrials.gov with the identifier NCT02130726 .