A senior surgical resident can safely perform complex esophageal cancer surgery after surgical mentoring program-experience of a European high-volume center.

Previous studies have shown that surgical residents can safely perform a variation of complex abdominal surgeries when provided with adequate training, proper case selection, and appropriate supervision. Their outcomes are equivalent when compared to experienced board-certified surgeons. Our previously published training curriculum for robotic assisted minimally invasive esophagectomy already demonstrated a possible reduction in time to reach proficiency. However, esophagectomy is a technically challenging procedure and comes with high morbidity rates of up to 60%, making it difficult to provide opportunities to train surgical residents. We aimed to investigate if a surgical resident could safely perform complex esophageal surgery when a structured modular teaching curriculum is applied. A structured teaching program based on our previously published modular step-up approach was applied by two experienced board-certified esophageal surgeons. Our IRB-approved (Institutional Review Board) database was searched to identify all Ivor-Lewis esophagectomies performed by the selected surgical resident from August 2019 to July 2021. The cumulative sum method was used to analyze the learning curve of the surgical resident. Outcomes of patients operated by the resident were then compared to our overall cohort of open, hybrid, and robotic Ivor-Lewis esophagectomies from May 2016 to May 2020. The total cohort included 567 patients, of which 65 were operated by the surgical resident and 502 patients were operated by experienced esophageal cancer surgeons as the control group. For baseline characteristics, a significant difference for BMI (Body mass index) was observed, which was lower in the resident's group (25.5 kg/m2 vs. 26.8 kg/m2 (P = 0.046). A significant difference of American Society of Anesthesiologists- and Eastern Cooperative Oncology Group-scores was seen, and a subgroup analysis including all patients with American Society of Anesthesiologists I and Eastern Cooperative Oncology Group 0 was performed revealing no significant differences. Postoperative complications did not differ between groups. The anastomotic leak rate was 13.8% in the resident's cohort and 12% in the control cohort (P = 0.660). Major complications (Clavien-Dindo ≥ IIIb) occurred in 16.9% of patients in both groups. Oncological outcome, defined by harvested lymph nodes (35 vs. 32.33, P = 0.096), proportion of lymph node compliant performed operations (86.2% vs. 88.4%, P = 0.590), and R0-resection rate (96.9% vs. 96%, P = 0.766), was not compromised when esophagectomies were performed by the resident. The resident completed the learning curves after 39 cases for the total operating time, 38 cases for the thoracic operating time, 26 cases for the number of harvested lymph nodes, 29 cases for anastomotic leak rate, and finally 58 cases for the comprehensive complication index. For postoperative complications, no significant difference was seen between patients operated in the resident group versus the control group, with a third of patients being discharged with a textbook outcome in both cohorts. Furthermore, no difference in oncological quality of the resection was found, emphasizing safety and feasibility of our training program. A structured modular step-up for training a surgical resident to perform complex esophageal cancer surgery can successfully maintain patient safety and outcomes.

Minimally invasive versus open gastrectomy for gastric cancer. A pooled analysis of two European randomized controlled trials.

INTRODUCTION: Minimally invasive techniques have shown better short term and similar oncological outcomes compared to open techniques in the treatment of gastric cancer in Asian countries. It remains unknown whether these outcomes can be extrapolated to Western countries, where patients often present with advanced gastric cancer. MATERIALS AND METHODS: A pooled analysis of two Western randomized controlled trials (STOMACH and LOGICA trial) comparing minimally invasive gastrectomy (MIG) and open gastrectomy (OG) in advanced gastric cancer was performed. Postoperative recovery (complications, mortality, hospital stay), oncological outcomes (lymph node yield, radical resection rate, 1-year survival), and quality of life was assessed. RESULTS: Three hundred and twenty-one patients were included from both trials. Of these, 162 patients (50.5%) were allocated to MIG and 159 patients (49.5%) to OG. A significant difference was seen in blood loss in favor of MIG (150 vs. 260 mL, p < 0.001), whereas duration of surgery was in favor of OG (180 vs. 228.5 min, p = 0.005). Postoperative recovery, oncological outcomes and quality of life were similar between both groups. CONCLUSION: MIG showed no difference to OG regarding postoperative recovery, oncological outcomes or quality of life, and is therefore a safe alternative to OG in patients with advanced gastric cancer.

Analysis of training pathway to reach expert performance levels based on proficiency-based progression in robotic-assisted minimally invasive esophagectomy (RAMIE).

BACKGROUND: Robotic-assisted minimally invasive esophagectomy (RAMIE) was first introduced in 2003 and has since then shown to significantly improve the postoperative course. Previous studies have shown that a structured training pathway based on proficiency-based progression using individual skill levels as measures of reach of competence can enhance surgical performance. The aim of this study was to evaluate and help understand our pathway to reach surgical expert levels using a proficiency-based approach introducing RAMIE at our German high-volume center. METHODS: All patients undergoing RAMIE performed by two experienced surgeons for esophageal cancer since the introduction of the robotic technique in 2017 was included in this analysis. Intraoperative outcomes and postoperative outcomes were included in the analysis. The cumulative sum method was used to analyze how many cases are needed to reach expert levels for different performance characteristics and skill sets during robotic-assisted minimally invasive esophagectomy. RESULTS: From 06/2017 to 03/2022, a total of 154 patients underwent RAMIE at our facility and were included in the analysis. An advancement in performance level was observed for total operating time after 70 cases and for thoracic operative time after 79 cases. Lymph node yield showed an increase up until case 60 in the CUSUM analysis. Length of hospital stay stabilized after case 55. The CCI score inflection point was at case 55 in both CUSUM and regression analyses. Anastomotic leak rate stabilized at case 38 and showed another inflection point after case 83. CONCLUSION: Our data and analysis showed the progression from proficient to expert performance levels during the implementation of RAMIE at a European high-volume center. Further analysis of surgeons, especially with a different training status has yet to reveal if the caseloads found in this study are universally applicable. However, skill acquisition and respective measures of such are diverse and as a great range of number of cases was observed, we believe that the learning curve and ascent in performance levels cannot be defined by one parameter alone.

Systematic review: robot-assisted versus conventional laparoscopic multiport cholecystectomy.

Laparoscopic cholecystectomy has become the standard of care for the treatment of symptomatic gallstone disease. In the context of the increasing uptake of robotic surgery, robotic cholecystectomy has seen a substantial growth over the past decades. Despite this, a formal assessment of the evidence for this practice remains elusive and a randomised controlled trial is yet to be performed. This paper reviews the evidence to date for robotic multiport cholecystectomy compared to conventional multiport cholecystectomy. This systematic review was performed conducted using the Medline, Embase and Cochrane databases; in line with the PRISMA guideline. All articles that compared robotic and conventional laparoscopic cholecystectomy were included. The studies were assessed with regards to operative outcomes, postoperative recovery and complications. Fourteen studies were included, describing a total of 3002 patients. There was no difference in operative blood loss, complication rates, incidence of bile duct injury or length of hospital stay between the robotic and laparoscopic groups. The operative time for robotic cholecystectomy was longer, whereas the risk of conversion to open surgery was lower. There was marked variation in definitions of measured outcomes, and most studies lacked data on training and quality assessment, leading to substantial heterogeneity of the data. Available evidence on multiport robotic cholecystectomy compared to conventional laparoscopic cholecystectomy is scarce and the quality of the available studies is generally poor. Results suggest longer operating time for robotic cholecystectomy, although many studies included the learning curve period. Postoperative recovery and complications were similar in both groups.

Proctored adoption of robotic hiatus hernia surgery: outcomes and learning curves in a high-volume UK centre.

BACKGROUND: The adoption of new surgical technologies is inevitably accompanied by a learning curve. With the increasing adoption of robotic techniques in benign foregut surgery, it is imperative to define optimal learning pathways, to ensure a clinically safe introduction of such a technique. The aim of this study was to assess the learning curve for robotic hiatal hernia repair with a pre-defined adoption process and proctoring. METHODS: The learning curve was assessed in four surgeons in a high-volume tertiary referral centre, performing over a 100 hiatal hernia repairs annually. The robotic adoption process included simulation-based training and a multi-day wet lab-based course, followed by robotic operations proctored by robotic upper GI experts. CUSUM analysis was performed to assess changes in operating time in sequential cases. RESULTS: Each surgeon (A, B, C and D) performed between 22 and 32 cases, including a total of 109 patients. Overall, 40 cases were identified as 'complex' (36.7%), including 16 revisional cases (16/109, 14.7%). With CUSUM analysis inflection points for operating time were seen after 7 (surgeon B) to 15 cases (surgeon B). CONCLUSION: The learning curve for robotic laparoscopic fundoplication may be as little as 7-15 cases in the setting of a clearly organized learning pathway with proctoring. By integrating these organized learning pathways learning curves may be shortened, ensuring patient safety, preventing detrimental outcomes due to longer learning curves, and accelerating adoption and integration of novel surgical techniques.

Three-year survival and distribution of lymph node metastases in gastric cancer following neoadjuvant chemotherapy: results from a European randomized clinical trial.

BACKGROUND: Adequate lymphadenectomy is an important step in gastrectomy for cancer, with a modified D2 lymphadenectomy being recommended for advanced gastric cancers. When assessing a novel technique for the treatment of gastric cancer, lymphadenectomy should be non-inferior. The aim of this study was to assess completeness of lymphadenectomy and distribution patterns between open total gastrectomy (OTG) and minimally invasive total gastrectomy (MITG) in the era of peri-operative chemotherapy. METHODS: This is a retrospective analysis of the STOMACH trial, a randomized clinical trial in thirteen hospitals in Europe. Patients were randomized between OTG and MITG for advanced gastric cancer after neoadjuvant chemotherapy. Three-year survival, number of resected lymph nodes, completeness of lymphadenectomy, and distribution patterns were examined. RESULTS: A total of 96 patients were included in this trial and randomized between OTG (49 patients) and MITG (47 patients). No difference in 3-year survival was observed, this was 57.1% in OTG group versus 46.8% in MITG group (P = 0.186). The mean number of examined lymph nodes per patient was 44.3 ± 16.7 in the OTG group and 40.7 ± 16.3 in the MITG group (P = 0.209). D2 lymphadenectomy of 71.4% in the OTG group and 74.5% in the MITG group was performed according to the surgeons; according to the pathologist compliance to D2 lymphadenectomy was 30% in the OTG group and 36% in the MITG group. Tier 2 lymph node metastases (stations 7-12) were observed in 19.6% in the OTG group versus 43.5% in the MITG group (P = 0.024). CONCLUSION: No difference in 3-year survival was observed between open and minimally invasive gastrectomy. No differences were observed for lymph node yield and type of lymphadenectomy. Adherence to D2 lymphadenectomy reported by the pathologist was markedly low.

The Impact of Reoperations Following Bariatric Surgery on Mid-term Outcomes.

PURPOSE: With the obesity epidemic, the number of bariatric procedures is increasing, and although considered relatively safe, major postoperative complications still occur. In cancer surgery, major complications such as reoperations have been associated with deteriorated mid/long-term outcomes. In obesity surgery, the effects of reoperations on postoperative weight loss and associated comorbidities remain unclear. The aim of this study was to assess mid-term weight loss and comorbidities following early reoperations in obesity surgery. METHODS: A population-based cohort study was performed within the Dutch Audit for Treatment of Obesity (DATO), including all patients that underwent a primary gastric bypass procedure or sleeve gastrectomy. Follow-up data was collected up until 5 years postoperatively on percentage total weight loss (%TWL) and comorbidities. RESULTS: A total of 40,640 patients underwent a gastric bypass procedure or sleeve gastrectomy between 2015 and 2018. Within this cohort, 709 patients (1.7%) suffered a major complication requiring reoperation within 30 days. %TWL at 24 months was 33.1 ± 9.2 in the overall population, versus 32.9 ± 8.7 in the patients who underwent a reoperation (p=0.813). Both analysis per year and Cox regression techniques revealed no differences in long-term follow-up regarding percentage TLW, and weight loss success rates (%TWL>20%) in patients who underwent a reoperation compared to patients without reoperation. At 5 years, the availability of follow-up data was low. No differences were observed in the remission of comorbidities. DISCUSSION: Major complications requiring reoperation within 30 days of gastric bypass surgery or sleeve gastrectomy did not affect long-term outcomes with regard to weight loss or remission of comorbidities.

Time to endoscopic vacuum therapy-lessons learned after > 150 robotic-assisted minimally invasive esophagectomies (RAMIE) at a German high-volume center.

OBJECTIVE OF THE STUDY: In esophageal surgery, anastomotic leak (AL) remains one of the most severe and critical adverse events after oncological esophagectomy. Endoscopic vacuum therapy (EVT) can be used to treat AL; however, in the current literature, treatment outcomes and reports on how to use this novel technique are scarce. The aim of this study was to evaluate the outcomes of patients with an AL after IL RAMIE and to determine whether using EVT as an treatment option is safe and feasible. MATERIAL AND METHODS: This study includes all patients who developed an Esophagectomy Complications Consensus Group (ECCG) type II AL after IL RAMIE at our center between April 2017 and December 2021. The analysis focuses on time to EVT, duration of EVT, and follow up treatments for these patients. RESULTS: A total of 157 patients underwent an IL RAMIE at our hospital. 21 patients of these (13.4%) developed an ECCG type II AL. One patient died of unrelated Covid-19 pneumonia and was excluded from the study cohort. The mean duration of EVT was 12 days (range 4-28 days), with a mean of two sponge changes (range 0-5 changes). AL was diagnosed at a mean of 8 days post-surgery (range 2-16 days). Closure of the AL with EVT was successful in 15 out of 20 patients (75%). Placement of a SEMS (Self-expandlable metallic stent) after EVT was performed in four patients due to persisting AL. Overall success rate of anastomotic sealing independently of the treatment modality was achieved in 19 out of 20 Patients (95%). No severe EVT-related adverse events occurred. CONCLUSION: This study shows that EVT can be a safe and effective endoscopic treatment option for ECCG type II AL.

[ICG lymph node mapping in cancer surgery of the upper gastrointestinal tract]. / ICG-Lymphknoten-Mapping in der Tumorchirurgie des oberen Gastrointestinaltrakts.

The importance of the assessment of the N­status in gastric carcinoma, tumors of the gastroesophageal junction and esophageal cancer is undisputed; however, there is currently no internationally validated method for lymph node mapping in esophageal and gastric cancer. Near-infrared fluorescence imaging (NIR) is an innovative technique from the field of vibrational spectroscopy, which in combination with the fluorescent dye indocyanine green (ICG) enables intraoperative real-time visualization of anatomical structures. The ICG currently has four fields of application in oncological surgery: intraoperative real-time angiography for visualization of perfusion, lymphography for visualization of lymphatic vessels, visualization of solid tumors, and (sentinel) lymph node mapping. For imaging of the lymph drainage area and therefore the consecutive lymph nodes, peritumoral injection of ICG must be performed. Several studies have demonstrated the feasibility of peritumoral injection of ICG administered 15 min to 3 days preoperatively with subsequent intraoperative visualization of the lymph nodes. So far prospective randomized studies on the validation of the method are still lacking. In contrast, the use of ICG for lymph node mapping and visualization of sentinel lymph nodes in gastric cancer has been performed in large cohorts as well as in prospective randomized settings. Up to now, multicenter studies for ICG-guided lymph node mapping during oncological surgery of the upper gastrointestinal tract are lacking. Artificial intelligence methods can help to evaluate these techniques in an automated manner in the future as well as to support intraoperative decision making and therefore to improve the quality of oncological surgery.

Risk factors for postoperative bleeding in bariatric surgery.

BACKGROUND: Postoperative bleeding remains a relatively common complication following bariatric surgery and may lead to morbidity and even mortality. OBJECTIVE: To develop a prediction model to identify patients at risk for postoperative bleeding. SETTING: Rode Kruis Ziekenhuis, Beverwijk, the Netherlands. Based on Dutch nationwide obesity audit data. METHODS: Patients undergoing primary bariatric surgery were selected from January 2015 to December 2020 from the Dutch Audit for Treatment of Obesity. The primary outcome was postoperative bleeding within 30 days. Assessed predictors included patient factors and operative data. A prediction model was developed using backward stepwise logistic regression. Internal validation was performed using bootstrapping techniques. RESULTS: A total of 59,055 patients were included; 13,399 underwent a sleeve gastrectomy, and 45,656 underwent a gastric bypass procedure. Postoperative bleeding occurred in 1.5%. The following predictors were identified: male patients (odds ratio [OR] = 1.40; 95% confidence interval [CI]: 1.21-1.63), patients >45 years of age (OR = 1.50; 95% CI: 1.29-1.76), body mass index <40 kg/m2 (OR = 1.22; 95% CI: 1.06-1.41), cardiovascular disease (OR = 1.36; 95% CI: 1.17-1.57), and sleeve gastrectomy (OR = 1.43; 95% CI: 1.24-1.67). Area under the curve for the model was .612. Following bootstrapping for internal validation, a correction of .9817 was applied. CONCLUSION: A clinical decision rule was designed to assess the risk of postoperative bleeding in patients undergoing bariatric surgery. If 3 or more risk factors are present, there is an increased risk for postoperative bleeding. The model can aid in clinical decision-making: implementing extra preventative measures in high-risk patients. External validation is needed to further develop the model.

Short-term outcome for high-risk patients after esophagectomy.

Transthoracic esophagectomy (TTE) for esophageal cancer facilitates mediastinal dissection; however, it has a significant impact on cardiopulmonary status. High-risk patients may therefore be better candidates for transhiatal esophagectomy (THE) in order to prevent serious complications. This study addressed short-term outcome following TTE and THE in patients that are considered to have a higher risk of surgery-related morbidity. This population-based study included patients who underwent a curative esophagectomy between 2011 and 2018, registered in the Dutch Upper GI Cancer Audit. The Charlson comorbidity index was used to assign patients to a low-risk (score ≤ 1) and high-risk group (score ≥ 2). Propensity score matching was applied to produce comparable groups between high-risk patients receiving TTE and THE. Primary endpoint was mortality (in-hospital/30-day mortality), secondary endpoints included morbidity and oncological outcomes. Additionally, a matched subgroup analysis was performed, including only cervical reconstructions. Of 5,438 patients, 945 and 431 high-risk patients underwent TTE and THE, respectively. After propensity score matching, mortality (6.3 vs 3.3%, P = 0.050), overall morbidity, Clavien-Dindo ≥ 3 complications, pulmonary complications, cardiac complications and re-interventions were significantly more observed after TTE compared to THE. A significantly higher mortality after TTE with a cervical reconstruction was found compared to THE (7.0 vs. 2.2%, P = 0.020). Patients with a high Charlson comorbidity index predispose for a complicated postoperative course after esophagectomy, this was more outspoken after TTE compared to THE. In daily practice, these outcomes should be balanced with the lower lymph node yield, but comparable positive node count and radicality after THE.

Laparoscopic versus open distal gastrectomy for gastric cancer: A systematic review and meta-analysis.

OBJECTIVE: Laparoscopic distal gastrectomy (LDG) with adequate lymph node dissection for gastric cancer is increasingly being applied worldwide. Several randomized trials have been conducted regarding this surgical approach. The aim of this meta-analysis is to present an updated overview comparing laparoscopic distal gastrectomy and open distal gastrectomy (ODG) with regard to short-term results, long-term follow-up, and oncological outcomes. METHODS: An extensive search was conducted using the Medline, Embase, and Cochrane databases, including randomized clinical trials comparing LDG and open distal gastrectomy. Studies were assessed regarding outcomes for operative results, postoperative recovery, complications, mortality, adequacy of resection, and long-term survival. RESULTS: In total, 2,347 articles were identified, and 22 randomized clinical trials were selected for analysis. Operative results showed significantly less blood loss and a longer operative time for LDG. Patients after LDG showed a faster recovery of bowel function, shorter hospitalization, and fewer complications, while mortality rates did not differ. Lymph node yield and resection margins were similar in both groups. Results regarding survival could not be analyzed due to a great diversity in follow-up duration. CONCLUSION: Laparoscopic distal gastrectomy shows favorable outcomes, such as less perioperative blood loss, faster patient recovery, and fewer complications. Moreover, LDG is oncologically adequate regarding lymph node yield, adequacy of resection, and survival.

Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial.

INTRODUCTION: Minimally invasive techniques show improved short-term and comparable long-term outcomes compared to open techniques in the treatment of gastric cancer and improved survival has been seen with the implementation of multimodality treatment. Therefore, focus of research has shifted towards optimizing treatment regimens and improving quality of life. MATERIALS AND METHODS: A randomized trial was performed in thirteen hospitals in Europe. Patients were randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG) after neoadjuvant chemotherapy. This study investigated patient reported outcome measures (PROMs) on health-related quality of life (HRQoL) following OTG or MITG, using the Euro-Qol-5D (EQ-5D) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires, modules C30 and STO22. Due to multiple testing a p-value < 0.001 was deemed statistically significant. 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. A response compliance of 80% was achieved for all PROMs. The EQ5D overall health score one year after surgery was 85 (60-90) in the open group and 68 (50-83.8) in the minimally invasive group (P = 0.049). The median EORTC-QLQ-C30 overall health score one year postoperatively was 83,3 (66,7-83,3) in the open group and 58,3 (35,4-66,7) in the minimally invasive group (P = 0.002). This was not statistically significant. CONCLUSION: No differences were observed between open total gastrectomy and minimally invasive total gastrectomy regarding HRQoL data, collected using the EQ-5D, EORTC QLQ-C30 and EORTC-QLQ-STO22 questionnaires.

Hospital Variation in Feeding Jejunostomy Policy for Minimally Invasive Esophagectomy: A Nationwide Cohort Study.

The purpose of this study was to investigate hospital variation in the placement, surgical techniques, and safety of feeding jejunostomies (FJ) during minimally invasive esophagectomy (MIE) in the Netherlands. This nationwide cohort study analyzed patients registered in the Dutch Upper Gastrointestinal Cancer Audit (DUCA) that underwent MIE for cancer. Hospital variation in FJ placement rates were investigated using case-mix corrected funnel plots. Short-term outcomes were compared between patients with and without FJ using multilevel multivariable logistic regression analysis. The incidence of FJ-related complications was described and compared between hospitals performing routine and non-routine placement (≥90%−<90% of patients). Between 2018−2020, an FJ was placed in 1481/1811 (81.8%) patients. Rates ranged from 11−100% among hospitals. More patients were discharged within 10 days (median hospital stay) without FJ compared to patients with FJ (64.5% vs. 50.4%; OR: 0.62, 95% CI: 0.42−0.90). FJ-related complications occurred in 45 (3%) patients, of whom 23 (1.6%) experienced severe complications (≥Clavien−Dindo IIIa). The FJ-related complication rate was 13.7% in hospitals not routinely placing FJs vs. 1.7% in hospitals performing routine FJ placement (p < 0.001). Significant hospital variation in the use of FJs after MIE exists in the Netherlands. No effect of FJs on complications was observed. FJs can be placed safely, with lower FJ-related complication rates, in centers performing routine placement.

C-reactive protein after major abdominal surgery in daily practice.

BACKGROUND: Infectious complications are frequently encountered after abdominal surgery. Early recognition, diagnosis, and subsequent timely treatment is the single most important denominator of postoperative outcome. This study prospectively addressed the predictive value of routine assessment of C-reactive protein levels as an early marker for infectious complications after major abdominal surgery. METHODS: Consecutive patients undergoing major abdominal surgery between November 2015 and November 2019 were prospectively enrolled. Routine C-reactive protein measurements were implemented on postoperative days 3, 4, and 5, and additional computed tomography examinations were performed on demand. The primary endpoint was the occurrence of Clavien-Dindo grade III or higher infectious complications. RESULTS: Of 350 patients, 71 (20.3%) experienced a major infectious complication, and median time to diagnosis was 7 days. C-reactive protein levels were significantly higher in patients with major infectious complications compared to minor or no infectious complications. The optimal cut-off was calculated for each postoperative day, being 175 mg/L on day 3, 130 mg/L on day 4, and 144 mg/L on day 5, and corresponding sensitivities, specificities, and positive and negative predictive values were over 80%, 65%, 40%, and 92% respectively. Alternative safe discharge cut-offs were calculated at 105 mg/L, 71 mg/L and 63 mg/L on days 3, 4, and 5, respectively, each having a negative predictive value of over 97%. CONCLUSION: The C-reactive protein cut-offs provided in this study can be used as a discharge criterion or to select patients that might require an invasive intervention due to infectious complications. These diagnostic criteria can easily be implemented in daily surgical practice.

Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy: results of a European randomized trial.

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.