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  • 1
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    Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA): A Multicenter Randomized Clinical Trial
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 9 ( 2021-03-20), p. 978-989
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 9 ( 2021-03-20), p. 978-989
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.20.01540
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 2
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    Distal Versus Total D2-Gastrectomy for Gastric Cancer: a Secondary Analysis of Surgical and Oncological Outcomes Including Quality of Life in the Multicenter Randomized LOGICA-Trial
    Springer Science and Business Media LLC ; 2023
    In:  Journal of Gastrointestinal Surgery Vol. 27, No. 9 ( 2023-09), p. 1812-1824
    Details
    In: Journal of Gastrointestinal Surgery, Springer Science and Business Media LLC, Vol. 27, No. 9 ( 2023-09), p. 1812-1824
    Abstract: Distal gastrectomy (DG) for gastric cancer can cause less morbidity than total gastrectomy (TG), but may compromise radicality. No prospective studies administered neoadjuvant chemotherapy, and few assessed quality of life (QoL). Methods The multicenter LOGICA-trial randomized laparoscopic versus open D2-gastrectomy for resectable gastric adenocarcinoma (cT1–4aN0–3bM0) in 10 Dutch hospitals. This secondary LOGICA-analysis compared surgical and oncological outcomes after DG versus TG. DG was performed for non-proximal tumors if R0-resection was deemed achievable, TG for other tumors. Postoperative complications, mortality, hospitalization, radicality, nodal yield, 1-year survival, and EORTC-QoL-questionnaires were analyzed using Χ 2 -/Fisher’s exact tests and regression analyses. Results Between 2015 and 2018, 211 patients underwent DG ( n  = 122) or TG ( n  = 89), and 75% of patients underwent neoadjuvant chemotherapy. DG-patients were older, had more comorbidities, less diffuse type tumors, and lower cT-stage than TG-patients ( p   〈  0.05). DG-patients experienced fewer overall complications (34% versus 57%; p   〈  0.001), also after correcting for baseline differences, lower anastomotic leakage (3% versus 19%), pneumonia (4% versus 22%), atrial fibrillation (3% versus 14%), and Clavien-Dindo grading compared to TG-patients ( p   〈  0.05), and demonstrated shorter median hospital stay (6 versus 8 days; p   〈  0.001). QoL was better after DG (statistically significant and clinically relevant) in most 1-year postoperative time points. DG-patients showed 98% R0-resections, and similar 30-/90-day mortality, nodal yield (28 versus 30 nodes; p  = 0.490), and 1-year survival after correcting for baseline differences ( p  = 0.084) compared to TG-patients. Conclusions If oncologically feasible, DG should be preferred over TG due to less complications, faster postoperative recovery, and better QoL while achieving equivalent oncological effectiveness. Mini-abstract Distal D2-gastrectomy for gastric cancer resulted in less complications, shorter hospitalization, quicker recovery and better quality of life compared to total D2-gastrectomy, whereas radicality, nodal yield and survival were similar.
    Type of Medium: Online Resource
    ISSN: 1091-255X , 1873-4626
    URL: Article
    DOI: 10.1007/s11605-023-05683-z
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2057634-1
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  • 3
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    Pain and Opioid Consumption After Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Secondary Analysis of a Multicenter Randomized Clinical Trial (LOGICA-Trial)
    Springer Science and Business Media LLC ; 2023
    In:  Journal of Gastrointestinal Surgery
    Details
    In: Journal of Gastrointestinal Surgery, Springer Science and Business Media LLC
    Abstract: Laparoscopic gastrectomy could reduce pain and opioid consumption, compared to open gastrectomy. However, it is difficult to judge the clinical relevance of this reduction, since these outcomes are reported in few randomized trials and in limited detail. Methods This secondary analysis of a multicenter randomized trial compared laparoscopic versus open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). Postoperative pain was analyzed by opioid consumption in oral morphine equivalents (OME, mg/day) at postoperative day (POD) 1–5, WHO analgesic steps, and Numeric Rating Scales (NRS, 0–10) at POD 1–10 and discharge. Regression and mixed model analyses were performed, with and without correction for epidural analgesia. Results Between 2015 and 2018, 115 patients in the laparoscopic group and 110 in the open group underwent surgery. Some 16 patients (14%) in the laparoscopic group and 73 patients (66%) in the open group received epidural analgesia. At POD 1–3, mean opioid consumption was 131, 118, and 53 mg OME lower in the laparoscopic group, compared to the open group, respectively (all p   〈  0.001). After correcting for epidural analgesia, these differences remained significant at POD 1–2 (47 mg OME, p  = 0.002 and 69 mg OME, p   〈  0.001, respectively). At discharge, 27% of patients in the laparoscopic group and 43% patients in the open group used oral opioids ( p  = 0.006). Mean highest daily pain scores were between 2 and 4 at all PODs,  〈  2 at discharge, and did not relevantly differ between treatment arms. Conclusion In this multicenter randomized trial, postoperative pain was comparable between laparoscopic and open gastrectomy. After laparoscopic gastrectomy, this was generally achieved without epidural analgesia and with fewer opioids. Trial Registration NCT02248519.
    Type of Medium: Online Resource
    ISSN: 1091-255X , 1873-4626
    URL: Article
    DOI: 10.1007/s11605-023-05728-3
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2057634-1
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  • 4
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    Body Composition Is a Predictor for Postoperative Complications After Gastrectomy for Gastric Cancer: a Prospective Side Study of the LOGICA Trial
    Springer Science and Business Media LLC ; 2022
    In:  Journal of Gastrointestinal Surgery Vol. 26, No. 7 ( 2022-07), p. 1373-1387
    Details
    In: Journal of Gastrointestinal Surgery, Springer Science and Business Media LLC, Vol. 26, No. 7 ( 2022-07), p. 1373-1387
    Abstract: There is a lack of prospective studies evaluating the effects of body composition on postoperative complications after gastrectomy in a Western population with predominantly advanced gastric cancer. Methods This is a prospective side study of the LOGICA trial, a multicenter randomized trial on laparoscopic versus open gastrectomy for gastric cancer. Trial patients who received preoperative chemotherapy followed by gastrectomy with an available preoperative restaging abdominal computed tomography (CT) scan were included. The CT scan was used to calculate the mass (M) and radiation attenuation (RA) of skeletal muscle (SM), visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT). These variables were expressed as Z -scores, depicting how many standard deviations each patient’s CT value differs from the sex-specific study sample mean. Primary outcome was the association of each Z -score with the occurrence of a major postoperative complication (Clavien-Dindo grade ≥ 3b). Results From 2015 to 2018, a total of 112 patients were included. A major postoperative complication occurred in 9 patients (8%). A high SM-M Z -score was associated with a lower risk of major postoperative complications (RR 0.47, 95% CI 0.28–0.78,  p  = 0.004). Furthermore, high VAT-RA Z -scores and SAT-RA Z -scores were associated with a higher risk of major postoperative complications (RR 2.82, 95% CI 1.52–5.23,  p  = 0.001 and RR 1.95, 95% CI 1.14–3.34,  p  = 0.015, respectively). VAT-M, SAT-M, and SM-RA Z -scores showed no significant associations. Conclusion Preoperative low skeletal muscle mass and high visceral and subcutaneous adipose tissue radiation attenuation (indicating fat depleted of triglycerides) were associated with a higher risk of developing a major postoperative complication in patients treated with preoperative chemotherapy followed by gastrectomy.
    Type of Medium: Online Resource
    ISSN: 1091-255X , 1873-4626
    URL: Article
    DOI: 10.1007/s11605-022-05321-0
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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  • 5
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    Cost-effectiveness of Laparoscopic vs Open Gastrectomy for Gastric Cancer : An Economic Evaluation Alongside a Randomized Clinical Trial
    American Medical Association (AMA) ; 2023
    In:  JAMA Surgery Vol. 158, No. 2 ( 2023-02-01), p. 120-
    Details
    In: JAMA Surgery, American Medical Association (AMA), Vol. 158, No. 2 ( 2023-02-01), p. 120-
    Abstract: Laparoscopic gastrectomy is rapidly being adopted worldwide as an alternative to open gastrectomy to treat gastric cancer. However, laparoscopic gastrectomy might be more expensive as a result of longer operating times and more expensive surgical materials. To date, the cost-effectiveness of both procedures has not been prospectively evaluated in a randomized clinical trial. Objective To evaluate the cost-effectiveness of laparoscopic compared with open gastrectomy. Design, Setting, and Participants In this multicenter randomized clinical trial of patients undergoing total or distal gastrectomy in 10 Dutch tertiary referral centers, cost-effectiveness data were collected alongside a multicenter randomized clinical trial on laparoscopic vs open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). A modified societal perspective and 1-year time horizon were used. Costs were calculated on the individual patient level by using hospital registry data and medical consumption and productivity loss questionnaires. The unit costs of laparoscopic and open gastrectomy were calculated bottom-up. Quality-adjusted life-years (QALYs) were calculated with the EuroQol 5-dimension questionnaire, in which a value of 0 indicates death and 1 indicates perfect health. Missing questionnaire data were imputed with multiple imputation. Bootstrapping was performed to estimate the uncertainty surrounding the cost-effectiveness. The study was conducted from March 17, 2015, to August 20, 2018. Data analyses were performed between September 1, 2020, and November 17, 2021. Interventions Laparoscopic vs open gastrectomy. Main Outcomes and Measures Evaluations in this cost-effectiveness analysis included total costs and QALYs. Results Between 2015 and 2018, 227 patients were included. Mean (SD) age was 67.5 (11.7) years, and 140 were male (61.7%). Unit costs for initial surgery were calculated to be €8124 (US $8087) for laparoscopic total gastrectomy, €7353 (US $7320) for laparoscopic distal gastrectomy, €6584 (US $6554) for open total gastrectomy, and €5893 (US $5866) for open distal gastrectomy. Mean total costs after 1-year follow-up were €26 084 (US $25 965) in the laparoscopic group and €25 332 (US $25 216) in the open group (difference, €752 [US $749; 3.0%]). Mean (SD) QALY contributions during 1 year were 0.665 (0.298) in the laparoscopic group and 0.686 (0.288) in the open group (difference, −0.021). Bootstrapping showed that these differences between treatment groups were relatively small compared with the uncertainty of the analysis. Conclusions and Relevance Although the laparoscopic gastrectomy itself was more expensive, after 1-year follow-up, results suggest that differences in both total costs and effectiveness were limited between laparoscopic and open gastrectomy. These results support centers’ choosing, based on their own preference, whether to (de)implement laparoscopic gastrectomy as an alternative to open gastrectomy.
    Type of Medium: Online Resource
    ISSN: 2168-6254
    URL: Article
    DOI: 10.1001/jamasurg.2022.6337
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2023
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  • 6
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    Trends in Distal Esophageal and Gastroesophageal Junction Cancer Care : The Dutch Nationwide Ivory Study
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Annals of Surgery Vol. 277, No. 4 ( 2023-04), p. 619-628
    Details
    In: Annals of Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 277, No. 4 ( 2023-04), p. 619-628
    Abstract: This study evaluated the nationwide trends in care and accompanied postoperative outcomes for patients with distal esophageal and gastro-esophageal junction cancer. Summary of Background Data: The introduction of transthoracic esophagectomy, minimally invasive surgery, and neo-adjuvant chemo(radio)therapy changed care for patients with esophageal cancer. Methods: Patients after elective transthoracic and transhiatal esophagectomy for distal esophageal or gastroesophageal junction carcinoma in the Netherlands between 2007–2016 were included. The primary aim was to evaluate trends in both care and postoperative outcomes for the included patients. Additionally, postoperative outcomes after transthoracic and tran-shiatal esophagectomy were compared, stratified by time periods. Results: Among 4712 patients included, 74% had distal esophageal tumors and 87% had adenocarcinomas. Between 2007 and 2016, the proportion of transthoracic esophagectomy increased from 41% to 81%, and neo-adjuvant treatment and minimally invasive esophagectomy increased from 31% to 96%, and from 7% to 80%, respectively. Over this 10-year period, postoperative outcomes improved: postoperative morbidity decreased from 66.6% to 61.8% ( P = 0.001), R0 resection rate increased from 90.0% to 96.5% (P 〈 0.001), median lymph node harvest increased from 15 to 19 ( P 〈 0.001), and median survival increased from 35 to 41 months ( P = 0.027). Conclusion: In this nationwide cohort, a transition towards more neo-adju-vant treatment, transthoracic esophagectomy and minimally invasive surgery was observed over a 10-year period, accompanied by decreased postoperative morbidity, improved surgical radicality and lymph node harvest, and improved survival.
    Type of Medium: Online Resource
    ISSN: 0003-4932
    URL: Article
    DOI: 10.1097/SLA.0000000000005292
    RVK:
    XA 23900
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2002200-1
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  • 7
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    18 F-Fludeoxyglucose–Positron Emission Tomography/Computed Tomography and Laparoscopy for Staging of Locally Advanced Gastric Cancer : A Multicenter Prospective Dutch Cohort Study (PLASTIC)
    American Medical Association (AMA) ; 2021
    In:  JAMA Surgery Vol. 156, No. 12 ( 2021-12-08), p. e215340-
    Details
    In: JAMA Surgery, American Medical Association (AMA), Vol. 156, No. 12 ( 2021-12-08), p. e215340-
    Type of Medium: Online Resource
    ISSN: 2168-6254
    URL: Article
    DOI: 10.1001/jamasurg.2021.5340
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2021
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  • 8
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    Pattern of lymph node metastases in gastric cancer: a side-study of the multicenter LOGICA-trial
    Springer Science and Business Media LLC ; 2022
    In:  Gastric Cancer Vol. 25, No. 6 ( 2022-11), p. 1060-1072
    Details
    In: Gastric Cancer, Springer Science and Business Media LLC, Vol. 25, No. 6 ( 2022-11), p. 1060-1072
    Abstract: The relation between gastric cancer characteristics and lymph node (LN) metastatic patterns is not fully clear, especially following neoadjuvant chemotherapy (NAC). This study analyzed nodal metastatic patterns. Methods Individual LN stations were analyzed for all patients from the LOGICA-trial, a Dutch multicenter randomized trial comparing laparoscopic versus open D2-gastrectomy for gastric cancer. The pattern of metastases per LN station was related to tumor location, cT-stage, Lauren classification and NAC. Results Between 2015–2018, 212 patients underwent D2-gastrectomy, of whom 158 (75%) received NAC. LN metastases were present in 120 patients (57%). Proximal tumors metastasized predominantly to proximal LN stations (no. 1, 2, 7 and 9; p   〈  0.05), and distal tumors to distal LN stations (no. 5, 6 and 8; OR  〉  1, p   〉  0.05). However, distal tumors also metastasized to proximal LN stations, and vice versa. Despite NAC, each LN station (no. 1–9, 11 and 12a) showed metastases, regardless of tumor location, cT-stage, histological subtype and NAC treatment, including station 12a for cT1N0-tumors. LN metastases were present more frequently in diffuse versus intestinal tumors (66% versus 52%; p  = 0,048), but not for cT3–4- versus cT1–2-stage (59% versus 51%; p  = 0.259). However, the pattern of LN metastases was similar for these subgroups. Conclusions The extent of lymphadenectomy cannot be reduced after NAC for gastric cancer. Although the pattern of LN metastases is related to tumor location, all LN stations contained metastases regardless of tumor location, cT-stage (including cT1N0-tumors), histological subtype, or NAC treatment. Therefore, D2-lymphadenectomy should be routinely performed during gastrectomy in Western patients.
    Type of Medium: Online Resource
    ISSN: 1436-3291 , 1436-3305
    URL: Article
    DOI: 10.1007/s10120-022-01329-2
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 1481763-9
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  • 9
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    Updated protocol of the SANO trial: a stepped-wedge cluster randomised trial comparing surgery with active surveillance after neoadjuvant chemoradiotherapy for oesophageal cancer
    Springer Science and Business Media LLC ; 2021
    In:  Trials Vol. 22, No. 1 ( 2021-12)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2021-12)
    Abstract: The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant chemoradiotherapy. The last patient with a clinically complete response is expected to be included in May 2021. The purpose of this update is to present all amendments to the SANO trial protocol as approved by the Institutional Research Board (IRB) before accrual is completed. Design The SANO trial protocol has been published ( 10.1186/s12885-018-4034-1 ). In this ongoing, phase-III, non-inferiority, stepped-wedge, cluster randomised controlled trial, patients with cCR (i.e. after neoadjuvant chemoradiotherapy no evidence of residual disease in two consecutive clinical response evaluations [CREs]) undergo either active surveillance or standard oesophagectomy. In the active surveillance arm, CREs are repeated every 3 months in the first year, every 4 months in the second year, every 6 months in the third year, and yearly in the fourth and fifth year. In this arm, oesophagectomy is offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant metastases. The primary endpoint is overall survival. Update Amendments to the study design involve the first cluster in the stepped-wedge design being partially randomised as well and continued accrual of patients at baseline until the predetermined number of patients with cCR is reached. Eligibility criteria have been amended, stating that patients who underwent endoscopic treatment prior to neoadjuvant chemoradiotherapy cannot be included and that patients who have highly suspected residual tumour without histological proof can be included. Amendments to the study procedures include that patients proceed to the second CRE if at the first CRE the outcome of the pathological assessment is uncertain and that patients with a non-passable stenosis at endoscopy are not considered cCR. The sample size was recalculated following new insights on response rates (34% instead of 50%) and survival (expected 2-year overall survival of 75% calculated from the moment of reaching cCR instead of 3-year overall survival of 67% calculated from diagnosis). This reduced the number of required patients with cCR from 264 to 224, but increased the required inclusions from 480 to approximately 740 patients at baseline. Conclusion Substantial amendments were made prior to closure of enrolment of the SANO trial. These amendments do not affect the outcomes of the trial compared to the original protocol. The first results are expected late 2023. If active surveillance plus surgery as needed after neoadjuvant chemoradiotherapy for oesophageal cancer leads to non-inferior overall survival compared to standard oesophagectomy, active surveillance can be implemented as a standard of care.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-021-05274-w
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2040523-6
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  • 10
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    Recurrent Disease After Esophageal Cancer Surgery : A Substudy of The Dutch Nationwide Ivory Study
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Annals of Surgery Vol. 276, No. 5 ( 2022-11), p. 806-813
    Details
    In: Annals of Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 276, No. 5 ( 2022-11), p. 806-813
    Abstract: This study investigated the patterns, predictors, and survival of recurrent disease following esophageal cancer surgery. Background: Survival of recurrent esophageal cancer is usually poor, with limited prospects of remission. Methods: This nationwide cohort study included patients with distal esophageal and gastroesophageal junction adenocarcinoma and squamous cell carcinoma after curatively intended esophagectomy in 2007 to 2016 (follow-up until January 2020). Patients with distant metastases detected during surgery were excluded. Univariable and multivariable logistic regression were used to identify predictors of recurrent disease. Multivariable Cox regression was used to determine the association of recurrence site and treatment intent with postrecurrence survival. Results: Among 4626 patients, 45.1% developed recurrent disease a median of 11 months postoperative, of whom most had solely distant metastases (59.8%). Disease recurrences were most frequently hepatic (26.2%) or pulmonary (25.1%). Factors significantly associated with disease recurrence included young age (≤65 y), male sex, adenocarcinoma, open surgery, transthoracic esophagectomy, nonradical resection, higher T-stage, and tumor positive lymph nodes. Overall, median postrecurrence survival was 4 months [95% confidence interval (95% CI): 3.6–4.4]. After curatively intended recurrence treatment, median survival was 20 months (95% CI: 16.4–23.7). Survival was more favorable after locoregional compared with distant recurrence (hazard ratio: 0.74, 95% CI: 0.65–0.84). Conclusions: This study provides important prognostic information assisting in the surveillance and counseling of patients after curatively intended esophageal cancer surgery. Nearly half the patients developed recurrent disease, with limited prospects of survival. The risk of recurrence was higher in patients with a higher tumor stage, nonradical resection and positive lymph node harvest.
    Type of Medium: Online Resource
    ISSN: 0003-4932
    URL: Article
    DOI: 10.1097/SLA.0000000000005638
    RVK:
    XA 23900
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2002200-1
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