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It is unknown whether Ivor Lewis (IL) or McKeown (McK) esophagectomy is preferred in patients with potentially curable esophageal or gastro-esophageal junction (GEJ) cancer. Patients with mid- and distal esophageal and GEJ cancer without distant metastases who underwent IL or McK esophagectomy in the Netherlands between 2015 and 2017, were selected from the Netherlands Cancer Registry. Patients were propensity score matched for sex, age, American Society of Anesthesiologist classification, comorbidity, tumor type, tumor location, clinical stage, neoadjuvant treatment and year of diagnosis. The primary outcome was a 3-year relative survival (RS). Secondary outcome parameters were number of lymph nodes examined, number of positive lymph nodes, radical resection rate, tumor regression grade, post-operative complications and mortality. A total of 1627 patients who underwent IL (n  = 1094) or McK (n  = 533) esophagectomy were included. Patient and tumor characteristics were balanced after propensity score matching, leaving 658 patients to be compared. The 3-year RS was 54% after IL and 50% after McK esophagectomy, P  = 0.140. The median number of lymph nodes examined, median number of positive lymph nodes, radical resection rate and tumor regression grade were comparable between both groups. Recurrent laryngeal nerve palsy (2 vs. 5%, P  = 0.006) occurred less frequently after IL esophagectomy. No differences were observed in post-operative anastomotic leakage rate, pulmonary complication rate and mortality rates. There was no statistically significant difference in the 3-year RS between IL and McK esophagectomy. Based on these results, both IL and McK esophagectomy can be performed in patients with mid to distal esophageal and GEJ cancer. [ABSTRACT FROM AUTHOR]

Background and aim Anastomotic leakage (AL) is a common and severe complication after esophagectomy, but it is largely unknown how to assess leakage severity at the time of diagnosis. We aimed to develop the Severity of Esophageal Anastomotic Leak (SEAL) score, a tool to predict leakage severity at the time of diagnosis. Methods The TENTACLE—Esophagus study is an international retrospective cohort study, in which 1509 patients with AL after esophagectomy between 2011 and 2019 were included in 71 centers from 20 countries. Potential predictors of mortality were patient parameters at diagnosis (e.g. diet at diagnosis, organ failure) and leakage parameters (e.g. fluid collections, gastric tube condition, leakage circumference). Primary outcome was 90-day mortality. Logistic regression was used to develop the SEAL score, comprising four grades of leakage severity (i.e. mild, moderate, severe and critical). Severity grade cut-offs were predefined and based on the individually predicted risk of 90-day mortality: 0–5%, 5–15%, 15–25% and 25–100%, respectively. Internal validation was performed by bootstrapping. The study protocol is accessible at www.tentaclestudy.com. Results The 90-day mortality rate in the included 1509 patients was 11.7%. The model had good discrimination (c-index 0.77; 95%CI 0.73–0.82) and calibration (calibration intercept 0.00; 95%CI -0.17– 0.17; calibration slope 1.14; 95%CI 0.95–1.33) after internal validation. The model classified 25.9% leakage patients as mild, 50.6% as moderate, 13.1% as severe and 10.4% as critical. The in-hospital, 30-day, 90-day and 180-day mortality rates, length of (ICU) stay, time to leak healing, Comprehensive Complication Index and Esophageal Complication Consensus Group classification worsened statistically significantly with higher classes of AL severity. Conclusion Anastomotic leakage is a severe complication with a 90-day mortality rate of 11.7%. The Severity of Esophageal Anastomotic Leak (SEAL) score is a tool which combines 12 patient and leak parameters at time of leak diagnosis and comprises four classes of leakage severity based on individual predictions of mortality. The SEAL score is instrumental in understanding AL severity in clinical practice and may be used to correct for leakage severity when assessing the efficacy of different treatments of AL after esophagectomy. [ABSTRACT FROM AUTHOR]

Background and aim Performance of the surgical team is essential for patient outcome. Minimally invasive esophagectomy (MIE) is a complex and technically demanding procedure and implementation is associated with a substantial learning curve. A validated, procedure specific and scientifically robust competency assessment tool (CAT) could provide structured feedback and can be a tool to improve patient outcome. The aim is to develop a MIE-CAT and assess construct validity, intra-observer reliability and inter-observer reliability. Methods Based on defined key steps from a Delphi study and refinement with a core group of MIE experts to establish content validity and obtain user agreement, the MIE-CAT was developed. Eighteen independent and blinded international MIE experts (> 120 MIEs performed) followed an online workshop to train in using the MIE-CAT and assessed Ivor Lewis MIE videos that were performed from 2010–2020 by four MIE surgeons from the Esophageal Center East Netherlands. To analyze construct validity, 32 videos were divided into four groups (novice, intermediate, advanced and expert) based on the surgical team's experience. For intra-rater and inter-rater reliability, the same video was scored twice by the same and different experts. Results The MIE-CAT consists of eight procedural phases, starting with the mobilization of the greater curvature and ending with creation of the intrathoracic anastomosis. Each phase contains four domains (exposure, execution, adverse events and end-product quality) and are scored with a 1–4 Likert scale. A total of 72 video assessments were used for analysis. Substantial performance variation between the MIE-CAT scores was seen (median 98 [IQR, 84–113.4]; range = 47–126). Median MIE-CAT scores were 79.5 [IQR 74–96.3], 91 [87.5–107], 101 [84.8–108] and 101 [95.5–108.3] for respectively the novice, intermediate, advanced and expert group (Figure 1). Significant differences between the average MIE-CAT scores of the experience groups were found with a Kruskal Wallis (P = 0.002). Good intra-rater reliability was observed (ICC, 0.71, 95% CI [0.35, 0.89) and moderate inter-rater reliability was observed (ICC, 0.54, 95% CI [0.10, 0.87). Conclusion A specific competency assessment tool to score the MIE performance, the MIE-CAT, was developed. It has the potential to be used for surgical training, safe implementation, performance improvement and research purposes. [ABSTRACT FROM AUTHOR]

Background and aim Anastomotic leakage (AL) is a common and severe complication after esophagectomy. It is largely unknown which primary treatments are most effective for which type of leak. We aimed to investigate the effectiveness of different primary treatments of AL after esophagectomy. Methods The TENTACLE—Esophagus study is an international retrospective cohort study, in which 1509 patients with AL after esophagectomy between 2011 and 2019 were included. Detailed data were collected regarding case mix, resection (e.g. minimally invasive resection), leakage characteristics (e.g. organ failure, leak circumference, intrathoracic contamination) and leakage treatment (e.g. hours from diagnosis to treatment, primary and secondary treatment modalities such as endoscopic, radiologic and surgical treatment). An elaborate data quality validation and data accuracy assessment were performed. Primary outcome was 90-day mortality and secondary outcomes included length of stay and leak healing time. Regression analysis will be used to analyze the effectiveness of primary treatments after correction for patient-, surgery-, and leakage characteristics, and leakage severity. Different clinically relevant leakage groups have been defined. Efficacy of different treatment strategies adjusted for leakage severity will be analyzed in these clinical groups. The full study protocol is accessible at www.tentaclestudy.com. Results Detailed data of 1509 patients with AL was collected from 71 centers in 20 countries. Data accuracy was 96.5%. Preliminary results showed that the overall 90-day mortality was 11.7%. The analysis of TENTACLE—Esophagus data is currently being performed and efficacy of different leakage treatment strategies is being assessed. The efficacy of initial leakage treatment strategies will be ready to be presented at the ESDE meeting. Conclusion This is the largest study on effectiveness of AL treatments. The final results on efficacy of primary leak treatments, which will be available for presentation at the ESDE meeting, could provide an evidence-based basis that can be used by clinicians to determine the preferred primary treatment strategy in patients with a given type of anastomotic leakage after esophagectomy. [ABSTRACT FROM AUTHOR]

Background and aim Transthoracic minimally invasive oesophagectomy (MIO) is increasingly performed as part of curative multimodality treatment. There is no robust evidence on the preferred location of the anastomosis after transthoracic MIO. The aim of this study was to compare an intrathoracic with a cervical anastomosis in a randomised controlled trial. Methods An open multicentre randomised controlled superiority trial was performed. Patients with mid to distal oesophageal or gastro-oesophageal junction cancer planned for curative resection were included. Patients were randomly assigned (1:1) to transthoracic MIO with intrathoracic or cervical anastomosis. The primary endpoint was anastomotic leakage requiring endoscopic, radiologic or surgical intervention. Secondary outcomes were overall anastomotic leak rate, other postoperative complications, length of stay, mortality and quality of life. The ICAN trial is registered in the Dutch trial register under number NTR4333. Results Two hundred and sixty-two patients were randomised and 245 were eligible for analysis. Anastomotic leakage necessitating re-intervention occurred in 15 of 122 (12.3%) patients with intrathoracic anastomosis and in 39 of 123 (31.7%) patients with cervical anastomosis (risk difference − 19.4%, 95% CI -29.5%—-9.3%). Overall anastomotic leak rate was 12.3% in the intrathoracic anastomosis group and 34.1% in the cervical anastomosis group (risk difference − 21.9%, 95% CI -32.1%—-11.6%). ICU length of stay, mortality rates and overall quality of life were comparable between groups, but intrathoracic anastomosis was associated with less severe complications, lower incidence of recurrent laryngeal nerve palsy and better quality of life in three subdomains. Conclusion Intrathoracic anastomosis is the preferred technique for patients treated with transthoracic MIO for mid to distal oesophageal or gastro-oesophageal junction cancer. [ABSTRACT FROM AUTHOR]

Totally minimally invasive Ivor–Lewis esophagectomy (Ivor Lewis TMIE) is a technically challenging procedure and is associated with a learning curve. Refinement of surgical technique is an important part of this learning curve. However, detailed descriptions of these refinements according to the idea, development, exploration, assessment, and long-term follow-up (IDEAL) framework are lacking and this study was undertaken to fill this knowledge gap. From 2010 until 2016, all consecutive patients (n  = 164) were included from the first patient undergoing Ivor Lewis TMIE. Surgical reports were analyzed and surgeons were interviewed to determine surgical refinements. These data were used to describe the transition of the surgical technique from IDEAL stage IIB to stage III. The main findings were that four refinements were made to the surgical procedure in IDEAL stage IIB: (1) At case 9, the use of the 25 mm OrVil was abandoned, exchanged for a 28 mm EEA stapler and a large omental wrap around the anastomosis was introduced; (2) at case 27, the omental wrap was reduced in volume; (3) at case 60, the omental wrap was refined to cover the full 360° of the anastomosis and (4) at case 77, the fixation of the anvil with the Endostitch was replaced by fixation with two Endoloops®. During the transition from IDEAL stage IIB to stage III, the incidence of anastomotic leakage decreased from 26.0% to 4.6% (P  < 0.001) and the incidence of textbook outcome increased from 31.2% to 47.1% (P  = 0.039). In conclusion, this study describes the surgical refinements that were made during the progression of Ivor Lewis TMIE from IDEAL stage IIB to IDEAL stage III. During IDEAL stage IIB, postoperative outcome improved as surgical proficiency was gained and the technique was refined. [ABSTRACT FROM AUTHOR]