The da Vinci Single-Port (SP) system received CE Mark approval for transoral robotic surgery in January 2024. Nevertheless, clinical experience with this platform in Europe remains limited - particularly in the field of minimally invasive head and neck surgery. In this report, we present the case of a 51-year-old man with p16-positive squamous cell carcinoma of the right tonsil who underwent transoral robotic resection using the da Vinci SP system, combined with contralateral tonsillectomy and bilateral neck dissection, at a German university hospital. To our knowledge, this represents one of the earliest reported oncologic applications of the da Vinci SP system in Germany following CE mark approval, highlighting its integration into established multimodal treatment pathways for oropharyngeal carcinoma. Further multicenter studies are required to define its role in clinical implementation compared with established techniques such as transoral laser microsurgery and earlier robotic systems.
OBJECTIVES:The role of upper mediastinal lymph node dissection (UMLND) in distal oesophageal and oesophagogastric junction (AEG) cancers remains debated, requiring a balance between potential oncologic benefit and surgical risk. This review provides an updated perspective on its role. METHODS:We analysed current evidence from retrospective studies, meta-analyses, and ongoing clinical trials, focusing on histology, tumour location, staging, neoadjuvant therapy response, and surgical outcomes. RESULTS:Routine UMLND is not supported for all distal oesophageal and AEG cancers. A standard 2-field dissection is sufficient for most patients with AEG adenocarcinoma. Extended 2-field dissection may be beneficial for squamous cell carcinoma of the upper and middle oesophagus and for adenocarcinoma with high-risk features, such as clinically positive upper mediastinal nodes or bulky abdominal/low-mid-mediastinal nodes. Current evidence highlights the need for a tailored surgical approach rather than uniform application. CONCLUSIONS:UMLND should not be considered routine but applied selectively according to tumour biology, location, and response to multimodal therapy. Future randomized data, particularly incorporating immunotherapy and advanced imaging and surgical techniques, will better define the optimal extent of lymphadenectomy in distinct patient subgroups.
BACKGROUND:Carcinomas of the stomach and esophagogastric junction (EGJ) are the fifth leading cause of cancer-related deaths worldwide. In Germany, gastric cancer ranks tenth in incidence across both sexes. The new German national guideline aims to provide the most relevant evidence-based recommendations on diagnosis and treatment of gastric and EGJ adenocarcinomas and has been comprehensively updated by an interdisciplinary panel of experts from national medical societies. SUMMARY:The updated S3 guideline reflects the latest advances in diagnostics, improved palliative therapies, and supportive care. The objectives are to improve the quality of individual and broad care and to ensure consistent, evidence-based treatment strategies. KEY MESSAGES:New recommendations introduce preventive strategies, including management of familial risk due to microsatellite instability (MSI) and H. pylori eradication. The biomarkers HER2, PD-L1, MSI, and Claudin 18.2 enable the use of targeted therapies that improve long-term outcomes in advanced disease. Combinations of chemotherapy with immunotherapy nivolumab, pembrolizumab, or tislelizumab significantly prolong survival compared with chemotherapy alone (e.g., nivolumab 14.4 vs. 11.1 months, HR 0.71; pembrolizumab 13.0 vs. 11.4 months, HR 0.75; tislelizumab 17.2 vs. 12.6 months, HR 0.74) with 5-year survival rates up to 16%. In patients with high Claudin 18.2 expression, zolbetuximab plus chemotherapy improved median survival to 16.4 vs. 13.4 months (HR 0.77). For patients in good general condition, subsequent lines of therapy including biomarker-driven approaches (trastuzumab deruxtecan, pembrolizumab) or third-line therapies (e.g., trifluridine tipiracil) and advanced molecular diagnostics are recommended after treatment failure.
Esophageal cancer is a global burden, and multiple international societies exist to address the issue in international collaboration. This study aims to analyze the characteristics of esophageal cancer and robot-assisted minimally invasive esophagectomy (RAMIE) across geographic areas. We performed a retrospective analysis of the Upper GI International Robotic Association (UGIRA) international database from January 2016 to April 2024. Forty centers worldwide that were known to perform RAMIE were involved in establishing this consortium. The patient characteristics, surgical techniques, and short-term outcomes of RAMIE were compared by each regional area (Europe, Asia, North America, and South America). A total of 3,916 RAMIE cases were registered in the UGIRA database (2,643 in Europe, 1,130 in Asia, 111 in North America, and 32 in South America). The median age was 66 years, and 80.5% of patients were male. Notably, Asia had a high prevalence of squamous cell carcinoma (91.2%) and predominant use of the McKeown approach (94.9%). BMI was lower in Asia, whereas comorbidities were more common in Western countries across all types. The use of neoadjuvant chemotherapy and radiation was lower in Asia (48.2% and 20.8 %, respectively). Postoperative complications also differed by region; pneumonia was most common in Europe and South America, cardiopulmonary complications in North America, and recurrent nerve injury in Asia. In conclusion, regional differences were observed in baseline characteristics, treatment approaches, and complication patterns in patients treated by RAMIE for esophageal cancer. Recognizing these variations is essential for fostering mutual understanding and advancing the field through international collaboration.
BACKGROUND:The best multimodal approach for resectable locally advanced esophageal adenocarcinoma is unclear. An important question is whether perioperative chemotherapy is preferable to preoperative chemoradiotherapy. METHODS:In this phase 3, multicenter, randomized trial, we assigned in a 1:1 ratio patients with resectable esophageal adenocarcinoma to receive perioperative chemotherapy with FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) plus surgery or preoperative chemoradiotherapy (radiotherapy at a dose of 41.4 Gy and carboplatin and paclitaxel) plus surgery. Eligibility criteria included a primary tumor with a clinical stage of cT1 cN+, cT2-4a cN+, or cT2-4a cN0 disease, in which T indicates the size and extent of the tumor (higher numbers indicate a more advanced tumor), and N indicates the presence (N+) or absence (N0) of cancer spread to the lymph nodes, without evidence of metastatic spread. The primary end point was overall survival. RESULTS:From February 2016 through April 2020, we assigned 221 patients to the FLOT group and 217 patients to the preoperative-chemoradiotherapy group. With a median follow-up of 55 months, overall survival at 3 years was 57.4% (95% confidence interval [CI], 50.1 to 64.0) in the FLOT group and 50.7% (95% CI, 43.5 to 57.5) in the preoperative-chemoradiotherapy group (hazard ratio for death, 0.70; 95% CI, 0.53 to 0.92; P = 0.01). Progression-free survival at 3 years was 51.6% (95% CI, 44.3 to 58.4) in the FLOT group and 35.0% (95% CI, 28.4 to 41.7) in the preoperative-chemoradiotherapy group (hazard ratio for disease progression or death, 0.66; 95% CI, 0.51 to 0.85). Among the patients who started the assigned treatment, grade 3 or higher adverse events were observed in 120 of 207 patients (58.0%) in the FLOT group and in 98 of 196 patients (50.0%) in the preoperative-chemoradiotherapy group. Serious adverse events were observed in 98 of 207 patients (47.3%) in the FLOT group and in 82 of 196 patients (41.8%) in the preoperative-chemoradiotherapy group. Mortality at 90 days after surgery was 3.1% in the FLOT group and 5.6% in the preoperative-chemoradiotherapy group. CONCLUSIONS:Perioperative chemotherapy with FLOT led to improved survival among patients with resectable esophageal adenocarcinoma as compared with preoperative chemoradiotherapy. (Funded by the German Research Foundation; ESOPEC ClinicalTrials.gov number, NCT02509286.).
Educating and training young surgeons is a complex challenge that requires a structured pathway. Upper gastrointestinal (UGI) surgery is becoming a highly attractive subspecialty, yet it is not universally recognized. Currently, there are no standardized guidelines or curricula for UGI surgical training across Europe and a wide disparity among countries remains. This study aims to focus on the current European landscape from the perspective of both trainees and trainers, and to provide a foundation for developing effective guidelines for education and training of surgical residents. We conducted a cross-sectional survey study with targeted questions about various aspects of managing patients with UGI diseases, including preoperative investigations, surgical interventions, interventional endoscopy, and postoperative follow-up. We also assessed the availability of training resources and extracurricular activities. Distinct questionnaires were distributed independently to trainees and trainers. The overall response rate was 35.6%. Most trainees and trainers recognized the need for dedicated courses in UGI surgery and emphasized the importance of learning through video materials. The survey revealed that surgeons are often unfamiliar with UGI endoscopy and functional esophageal function studies. We analyzed residents' direct involvement in three surgical procedures: anti-reflux surgery, gastrectomy, and esophagectomy. Residents expressed a lack of confidence in executing certain surgical steps. Both trainers and residents expressed preference for extracurricular, hands-on courses focused on UGI surgery but reported insufficient opportunities for such training. This survey highlights significant gaps and limitations of UGI training for surgical residents in Europe. Efforts toward standardization and development of specific guidelines and recommendations are required to enhance education in UGI surgery.
The optimal technique for intrathoracic esophagogastric anastomosis in esophagectomy remains undetermined. This study evaluates different anastomotic techniques in robot-assisted minimally invasive esophagectomy (RAMIE) and their impact on anastomotic leakage rates. This observational, retrospective, comparative cohort study analyzed data obtained from the Upper GI International Robotic Association (UGIRA) Esophageal Registry. All consecutive patients with a histologically proven esophageal malignancy who underwent RAMIE with intrathoracic esophagogastrostomy were included. The anastomotic technique was performed based on the clinical judgement and expertise of each individual surgeon. For comparison, the four most common techniques were included: circular end-to-side, linear side-to-side, handsewn end-to-side, and handsewn end-to-end. The primary endpoint of this study was the occurrence of anastomotic leakage, defined by the Esophagectomy Complications Consensus Group as a full-thickness gastrointestinal defect involving the esophagus, anastomosis, staple line, or conduit, regardless of its presentation or method of identification. Between 2016 and September 2023, 1518 patients were included. Univariable analysis demonstrated that the linear stapled side-to-side anastomosis was associated with the lowest anastomotic leakage rate (14.0
BACKGROUND:After the ESOPEC trial showed a survival benefit for fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT)-treated adenocarcinomas of the esophagus (EAC) and the gastroesophageal junction (GEJ) compared with Chemoradiotherapy for Oesophageal Cancer Followed by Surgery Study (CROSS), a European, high-volume center study for stage cT2cN0 EAC and GEJ was undertaken, as it has been published that a third of these patients are understaged and could benefit from a multimodal approach PATIENTS AND METHODS: Retrospective analysis of prospective databases from ten high-volume European centers was performed. Inclusion criteria were GEJ Siewert type I/II or EAC with cT2cN0 status at diagnosis undergoing multimodal treatment with FLOT or CROSS. Primary endpoint was overall survival (OS) RESULTS: Between 2012 and 2023, 133 patients met the inclusion criteria, of whom 73 (54.9%) received CROSS and 60 (45.1%) underwent treatment with FLOT. In both groups, patients were mainly male (p = 0.08), older than 70 years (p = 0.24), and had American Society of Anesthesiologists (ASA) II classification (p = 0.45). Regarding surgical treatment, more patients underwent gastrectomy in the FLOT than in the CROSS cohort (23.3% versus 6.8%, p = 0.007). There were no differences regarding pT, pN, and pM category (p > 0.05). Median survival was not reached, while mean survival was 74.6 months (95% CI 60.5-88.7 months) for CROSS versus 100.8 months (95% CI 72.5-94.5 months, p = 0.028) for FLOT. The 3-year survival was 87% in the FLOT group versus 59% in the CROSS group. In multivariable analyses, FLOT was independent factor for survival (p < 0.001) CONCLUSIONS: For cT2cN0 staged EAC and GEJ type I /II patients FLOT chemotherapy showed a survival benefit and should be the preferred treatment in a multimodal approach.
Objective:Tracheoesophageal fistula (TEF) is a severe complication often associated with advanced thoracic malignancies or chemoradiotherapy. This study introduces an innovative approach combining endoscopic submucosal dissection (ESD) and esophageal bypass surgery. This retrospective study aimed to evaluate the prognosis of patients with TEF in complete clinical remission after definitive chemoradiotherapy who underwent repair with such approach. Methods:This is a retrospective analysis of 12 patients with TEF secondary to thoracic malignancies treated between June 2021 and June 2022. Patients underwent ESD for de-epithelialization of the esophageal lumen, followed by esophageal bypass surgery. Key outcomes included survival rates, fistula closure rates, postoperative clinical outcomes, and functional status improvement assessed by Karnofsky Performance Status scores. Results:All patients had complete clinical remission of their primary malignancies before treatment. TEF closure was achieved in 10 patients (83.3%) within 28 to 72 days post-ESD. Median duration from ESD to bypass surgery was 39 days. Kaplan-Meier analysis revealed a 1-year survival rate of 65% and a 2-year survival rate of 60%. Postoperative morbidity included 1 anastomotic leak and 1 case of esophageal mucoceles, both successfully managed. Functional outcomes significantly improved, with 91.6% of patients achieving a Karnofsky Performance Status score >80 at 6 months. Conclusions:The combination of ESD and esophageal bypass surgery represents a promising approach for TEF management, demonstrating high rates of fistula closure, enhanced functional outcomes, and overall survival. Future studies should aim to validate these findings in larger cohorts and explore the long-term sustainability of these outcomes.
Esophageal cancer (EC) remains a leading cause of cancer-related mortality worldwide. For patients with locally advanced, non-metastatic EC, advances in perioperative care, and surgical techniques have led to improved outcomes; however, significant variation persists, and standardization remains limited. This study aimed to characterize current practice patterns among expert surgeons at high-volume European centers through a structured, in-depth survey. Eight expert upper gastrointestinal surgeons from European centers performing >60 esophagectomies annually participated in comprehensive interviews. Topics included preoperative care pathways for distal esophageal/gastroesophageal junction adenocarcinoma, technical aspects of Ivor Lewis esophagectomy, and postoperative recovery protocols. Additional focus areas included multidisciplinary team involvement, allied health integration, research program participation, and follow-up strategies. Widespread agreement (7-8 of 8 centers) was observed in several domains: national EC care regionalization, multidisciplinary cancer conference review of all patients, institutional EC research programs, use of prospective national/international databases, application of CROSS chemoradiotherapy for squamous cell carcinoma, and perioperative FLOT chemotherapy for adenocarcinoma. Common surgical techniques included minimally invasive Ivor Lewis esophagectomy, two-field lymphadenectomy with en-bloc thoracic duct ligation, nasogastric tube placement, omental wrap of the anastomosis, and Enhanced Recovery After Surgery-based postoperative protocols. The majority of centers (5-6/8) performed routine preoperative optimization (nutrition, smoking cessation, frailty screening, oral hygiene/microbiome assessment), jejunostomy placement, and postoperative contrast swallow studies. Areas with notable variability (≤4/8 centers) included intraoperative crural closure, pyloric drainage procedures, gastric conduit sizing, postoperative pain management, and follow-up imaging timelines. High-volume European centers demonstrated strong alignment in several programmatic and perioperative elements of EC care, particularly around enhanced recovery pathways and preoperative optimization. Nonetheless, key intraoperative and postoperative variations persist, highlighting opportunities for future research, consensus building, and standardization to improve patient outcomes.
BACKGROUND:To reduce the clinical and economic burden of complications after gastrectomy for gastric cancer, specific complications should be targeted to effectively allocate healthcare resources for quality improvement and preventive measures. The aim of this study was to assess the impact of complications on clinical outcomes. METHODS:This was a retrospective multicentre study of patients who underwent (sub)total gastrectomy for gastric or junctional adenocarcinoma at 43 centres in 16 countries between 2017 and 2021. Outcomes were escalation of care, reoperation, prolonged hospital stay (greater than the 75th percentile), readmission, and 30-day mortality. Adjusted relative risks and population attributable fractions were estimated for specific complication-outcome pairs. The population attributable fraction represents the percentage reduction in the frequency of an adverse outcome if a complication could be completely prevented in the population. RESULTS:In total, 7829 patients were included. Postoperative complications occurred in 1884 patients (24.1%). The most frequent complications were pulmonary complications (436 patients (5.6%)), anastomotic leakage (363 patients (4.6%)), and abdominal collection (301 patients (3.8%)). Anastomotic leakage, cardiac complications, and pulmonary complications had the greatest impact on 30-day mortality (population attributable fraction 26.6% (95% c.i. 14.5% to 38.6%), 18.7% (95% c.i. 9.4% to 28.0%), and 15.6% (95% c.i. 12.0% to 30.0%) respectively). Anastomotic leakage and pulmonary complications had the greatest impact on escalation of care (population attributable fraction 26.3% (95% c.i. 20.6% to 32.0%) and 18.4% (95% c.i. 11.7% to 25.2%) respectively), whereas anastomotic leakage and intra-abdominal bleeding had the greatest impact on reoperation (population attributable fraction 31.6% (95% c.i. 26.4% to 36.9%) and 8.5% (95% c.i. 5.5% to 11.5%) respectively). Most of the studied complications contributed to a prolonged hospital stay, whereas the contribution of complications to readmission did not exceed 15.9%. Subgroup analysis showed regional variation in the impact of complications. CONCLUSION:Anastomotic leakage had the largest overall negative impact on clinical outcomes after gastrectomy for gastric adenocarcinoma. Reducing the incidence of anastomotic leakage and pulmonary complications would have the most impact on the burden of complications.
The higher rate of pathological complete response (pCR) after neoadjuvant chemoradiotherapy (NACRT) is an argument to support this treatment. However, previous studies have not demonstrated a survival benefit of NACRT for adenocarcinoma (ADC) compared with neoadjuvant chemotherapy (NACT) and the correlation between pathological tumor response (pTR) and survival is unclear. We aimed to verify whether the prognostic value of pTRis influenced by the type of neoadjuvant treatment performed. Patients with ADC who underwent NACT or NACRT and surgery between 2015 and 2020 were included. The correlation between pTR and overall survival (OS) and disease-free survival (DFS) after both treatments was evaluated by using Kaplan-Meier analysis. pTR was assessed by using the Mandard tumor regression grade (TRG). Overall, 563 patients were included; 278 received NACT, and 285 NACRT. The incidence of pCR was significantly higher after NACRT (24.6
Objective: Positive peritoneal cytology is traditionally viewed as representative of metastatic disease and a poor prognostic factor. The objective of this multi-center study was to define the prognostic role of peritoneal cytology in curative gastrectomy, evaluate international variation in cytology sampling, and assess the impact on positive peritoneal cytology yields. Methods: This was a multi-center international retrospective cohort study of 16 tertiary gastric cancer centers. Adult patients who underwent peritoneal lavage cytology at staging laparoscopy and subsequent gastrectomy between 2009 and 2023 were included. The primary outcome measure was overall survival at five years. Multivariable Cox regression provided hazard ratios (HRs) with 95 % CIs, adjusted for relevant confounding factors. Results: 837 patients with no radiological or macroscopic M1 disease were included, with a mean age of 66 (IQR 58-73) and 71 % were male. Non-distal gastric cancer was most common (47 %), with 59 % and 43 % of tumors staged pT3/4 and pN2/3, respectively. 66 patients (7.9 %) had positive cytology. Positive cytology was not associated with overall survival in multivariable analysis, controlled for stage and neoadjuvant treatment (HR=1.0; 95 %CI 0.51-2.0). Higher T and N stages were associated with positive cytology (p < 0.001). The proportion of patients with positive cytology was variable, depending on how many quadrants were sampled. Conclusion: Positive peritoneal cytology with otherwise M0 disease was not associated with decreased survival after curative intent gastrectomy in this study, meaning prospective study is needed. The technique of performing peritoneal washings influenced cytology yield and thus must be standardized in a much-needed prospective evaluation of peritoneal cytology. Synopsis: The POPEC multicenter international retrospective cohort study included 837 patients receiving curative gastrectomy. This study showed the technique of performing peritoneal washings influenced cytology yield, however positive peritoneal cytology was not associated with decreased survival. Therefore, positive peritoneal cytology should not be considered an absolute contradiction to curatively intended gastrectomy.
Minimally invasive esophagectomies, including robot-assisted procedures, have demonstrated superiority over traditional open surgery. Despite the prevalence of transhiatal and transthoracic approaches, cervical access is less common in minimally invasive esophageal surgery. Advancements in robotic systems, such as the daVinci Single-Port (SP), now enable controlled transcervical extrapleural mediastinoscopic access, potentially reducing pulmonary complications and extending surgical options to patients with comorbidities. The daVinci SP Robot-Assisted Cervical Esophagectomy (SP-RACE) employs a single port and laparoscopic approach, demonstrating feasibility with comparable lymphadenectomy and recurrent nerve palsy rates to transthoracic methods. This technique, performed for the first time in Europe at the University Hospital Mainz, involves a transcervical SP-phase that allows for effective mediastinal dissection and esophageal mobilization. Despite technical challenges due to limited space, robotic systems enhance controlled access and eliminate arm collision. The daVinci SP platform's advantages include improved triangulation, fewer interferences, and better control of instruments in confined spaces. This novel approach shows promise for patients with high esophageal tumors and those unsuitable for transthoracic surgery, warranting further investigation into its clinical utility and reproducibility.
Reasons for structural and outcome differences in esophageal cancer surgery in Western Europe remain unclear. This questionnaire study aimed to identify differences in the organization of esophageal cancer surgical care in Western Europe. A cross-sectional international questionnaire study was conducted among upper gastrointestinal (GI) surgeons from Western Europe. One surgeon per country was selected based on scientific output and active membership in the European Society for Diseases of the Esophagus or (inter)national upper GI committee. The questionnaire consisted of 51 structured questions on the structural organization of esophageal cancer surgery, surgical training, and clinical audit processes. Between October 2021 and October 2022, 16 surgeons from 16 European countries participated in this study. In 5 countries (31%), a volume threshold was present ranging from 10 to 26 annual esophagectomies, in 7 (44%) care was centralized in designated centers, and in 4 (25%) no centralizing regulations were present. The number of centers performing esophageal cancer surgery per country differed from 4 to 400, representing 0.5-4.9 centers per million inhabitants. In 4 countries (25%), esophageal cancer surgery was part of general surgical training and 8 (50%) reported the availability of upper GI surgery fellowships. A national audit for upper GI surgery was present in 8 (50%) countries. If available, all countries use the audit to monitor the quality of care. Substantial differences exist in the organization and centralization of esophageal cancer surgical care in Western Europe. The exchange of experience in the organizational aspects of care could further improve the results of esophageal cancer surgical care in Europe.
Das Ösophaguskarzinom zählt zu den aggressivsten malignen Erkrankungen mit weltweit steigender Inzidenz. Die chirurgische Resektion bleibt nach wie vor die einzige kurative Therapieoption im Rahmen eines multimodalen Behandlungsansatzes. In den letzten Jahrzehnten haben minimal-invasive Verfahren wie die hybrid-minimal-invasive Ösophagektomie (HMIE) und die vollständig minimal-invasive Ösophagektomie (MIE) zunehmend an Bedeutung gewonnen. Studien wie ROMIO, ROBOT und RAMIE zeigen, dass diese Ansätze postoperative Komplikationen, insbesondere pulmonale und kardiovaskuläre, reduzieren können, ohne die onkologischen Langzeitergebnisse zu beeinträchtigen. Die roboterassistierte minimal-invasive Ösophagektomie (RAMIE) stellt eine Weiterentwicklung dar, die durch präzisere Dissektion (Präzisionschirurgie), geringeren Blutverlust und verbesserte Lymphknotendissektion zusätzliche Vorteile bietet. Die ROBOT-, RAMIE- und REVATE-Studien sowie weitere Analysen heben die Bedeutung dieses Verfahrens hervor, insbesondere bei Patienten mit Plattenepithelkarzinomen. Die laufende ROBOT2-Studie zielt darauf ab, die Evidenzbasis weiter zu stärken. Innovative Technologien, wie das Single-Port-da-Vinci-Robotersystem (Fa. Intuitive Surgical, Sunnyvale/CA, USA), bieten neue Perspektiven mit potenziell weniger Schmerzen und schnelleren Erholungszeiten, insbesondere für Patienten mit mehreren Komorbiditäten, die einen transzervikalen Zugang benötigen (SP-RACE; Single-Port da Vinci Robot-Assisted Cervical Esophagectomy), da dabei die Eröffnung der rechten Pleura und die Notwendigkeit einer Ein-Lungen-Ventilation vermieden werden. Zukünftige Entwicklungen wie das hinotori™-System (Fa. Medicaroid, Kobe, Japan) könnten die chirurgische Praxis weiter revolutionieren. Trotz der Fortschritte sind jedoch noch langfristige Daten erforderlich, um die onkologische Äquivalenz und den Nutzen neuer robotischer Ansätze umfassend zu belegen.
LBA1 Background: The most effective multimodal approach for treatment of resectable locally advanced esophageal adenocarcinoma (EAC) is under debate. A prior ranking question is if neoadjuvant chemoradiation therapy or perioperative chemotherapy is superior. ESOPEC (NCT02509286) is a multicenter prospective randomized trial comparing neoadjuvant CROSS (41.4Gy plus carboplatin/paclitaxel) followed by surgery versus perioperative FLOT (5-FU/ leucovorin/oxaliplatin/docetaxel) and surgery for the curative treatment of EAC. Methods: Patients with cT1 cN+ cM0 or cT2-4a cNany cM0 resectable EAC were eligible. The primary endpoint is overall survival (OS; 90% power; hazard ratio [HR] 0.645, 218 events needed; one sided significance level of 2.5%). Analysis is by intention-to-treat in all randomized patients. The effect of treatment on OS is estimated using Cox regression stratified by study site, and including N stage (N0, N+), and age as covariates. Results: Between Feb 2016 and Apr 2020, 438 patients from 25 sites in Germany were randomly assigned to two treatment groups (221 FLOT; 217 CROSS). Baseline characteristics (male sex 89.3%, median age 63 [range 30-86], cT3/4 80.5%; cN+ 79.7%) were well balanced between both arms. Neoadjuvant treatment was started in 403 patients (207 FLOT; 196 CROSS). Surgery was done in 371 patients (191 FLOT; 180 CROSS). R0 resection was achieved in 351 patients (180 FLOT; 171 CROSS). 90 days postsurgical mortality was 4.3% (3.2% FLOT; 5.6% CROSS). After a median follow up of 55 months, 218 patients had died (97 FLOT; 121 CROSS). Median OS was 66 (95% CI 36 – not estimable) months in the FLOT arm, and 37 (95% CI 28 – 43) months in the CROSS arm. The 3-year OS rates were 57.4% (95% CI 50.1 – 64.0%) for FLOT and 50.7% (95% CI 43.5 – 57.5%) for CROSS (HR 0.70, 95% CI 0.53-0.92, p=0.012). In 359 patients with available tumor regression status, pathological complete response was achieved in 35 (19.3%, 95%-CI 13.9 – 25.9%) in FLOT and in 24 (13.5%, 95%-CI 8.8 – 19.4%) in CROSS. Conclusions: Perioperative FLOT improves survival in resectable EAC compared to neoadjuvant CROSS. Funding: The trial was funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), project number 264590883. Clinical trial information: NCT02509286 .
Introduction In minimally invasive esophagectomy, a circular stapled anastomosis is common, but no evidence exists investigating the role of the specific localization of the anastomosis. The aim of this study is to evaluate the impact of an esophagogastrostomy on the anterior or posterior wall of the gastric conduit on the postoperative outcomes. Material and methods All oncologic minimally invasive Ivor Lewis procedures, performed between 2017 and 2022, were included in this study. The cohort was divided in two groups: a) intrathoracic esophagogastrostomy on the anterior gastric wall of the conduit (ANT, n = 285, 65%) and b) on the posterior gastric wall (POST, n = 154, 35%). Clinicopathological parameters and short-term outcomes were compared between both groups by retrieving data from the prospective database. Results Overall, 439 patients were included, baseline characteristics were similar in both groups, there was a higher proportion of squamous cell carcinoma in ANT (22.8% vs. 16.2%, P = 0.043). A higher rate of robotic-assisted procedures was observed in ANT (71.2% vs. 49.4%). Anastomotic leakage rate was similar in both groups (ANT 10.4% vs. POST 9.8%, P = 0.851). Overall complication rate and Clavien–Dindo > 3 complication rates were higher in POST compared to ANT: 53.2% vs. 40% ( P = 0.008) and 36.9% vs. 25.7% ( P = 0.014), respectively. The rate of delayed gastric emptying (20.1% vs. 7.4%, P < 0.001) and nosocomial pneumonia (22.1% vs. 14.8%, P = 0.05) was significantly higher in POST. Conclusion Patients undergoing minimally invasive Ivor Lewis esophagectomy with an intrathoracic circular stapled anastomosis may benefit from esophagogastrostomy on the anterior wall of the gastric conduit, in terms of lower rate of delayed gastric emptying.