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Objective: To compare overall survival of patients with a cCR undergoing active surveillance versus standard esophagectomy. Summary of Background Data: One-third of patients with esophageal cancer have a pathologically complete response in the resection specimen after neoadjuvant chemoradiotherapy. Active surveillance may be of benefit in patients with cCR, determined with diagnostics during response evaluations after chemoradiotherapy. Methods: A systematic review and meta-analysis was performed comparing overall survival between patients with cCR after chemoradiotherapy undergoing active surveillance versus standard esophagectomy. Authors were contacted to supply individual patient data. Overall and progression-free survival were compared using random effects meta-analysis of randomized or propensity score matched data. Locoregional recurrence rate was assessed. The study-protocol was registered (PROSPERO: CRD42020167070). Results: Seven studies were identified comprising 788 patients, of which after randomization or propensity score matching yielded 196 active surveillance and 257 standard esophagectomy patients. All authors provided individual patient data. The risk of all-cause mortality for active surveillance was 1.08 [95% confidence interval (CI): 0.62-1.87, P = 0.75] after intention-to-treat analysis and 0.93 (95% CI: 0.56-1.54, P = 0.75) after per-protocol analysis. The risk of progression or all-cause mortality for active surveillance was 1.14 (95% CI: 0.83-1.58, P = 0.36). Five-year locoregional recurrence rate during active surveillance was 40% (95% CI: 26%-59%). 95% of active surveillance patients undergoing postponed esophagectomy for locoregional recurrence had radical resection. Conclusions: Overall survival was comparable in patients with cCR after chemoradiotherapy undergoing active surveillance or standard esophagectomy. Diagnostic follow-up is mandatory in active surveillance and postponed esophagectomy should be offered to operable patients in case of locoregional recurrence. [ABSTRACT FROM AUTHOR]

Esophageal surgery is historically associated with adverse postoperative outcomes. Selected high-volume centers have previously reported the effect on clinical outcomes following the adoption of a standardized clinical pathway (SCP). This meta-analysis aims to evaluate the current literature to document the effect of SCP and enhanced recovery after surgery (ERAS) on esophagectomy outcomes. A literature search was conducted through the main search engines (PubMed, Embase, Medline, and Cochrane database) in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. All eligible comparative studies (randomized control trial, prospective, retrospective, and combined) were identified and assessed based on Methodological Index for Non-Randomized Studies and Jadad quality criteria. Data concerning overall morbidity, early mortality, and length of stay (LOS) were primarily collected and compared. Secondary outcomes included anastomotic leaks, pulmonary complications, and readmission rate. Twenty-six articles (including five randomized controlled trials and six prospective trials) were included in the analysis. Overall study quality was moderate and the included studies utilized a variable approach to SCP. No statistically significant differences were found between groups in terms of overall morbidity, postoperative mortality, anastomotic leak, and readmission rates. Significant improvements included pulmonary complications (odds ratios [OR] 0.66, 95% confidence interval [CI] 0.49–0.94) and hospital LOS (OR −3.68, 95% CI −4.49 to −2.87). Previous reports of SCP within esophagectomy programs have demonstrated clinical improvements in postoperative pulmonary complications and LOS. Given the high heterogeneity historically demonstrated within SCPs, further improvement in outcomes should be expected following the adoption of standardized ERAS guidelines. [ABSTRACT FROM AUTHOR]

Background: 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 ( https://doi.org/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. [ABSTRACT FROM AUTHOR]

Objective: This nation-wide population-based study aimed to report postoperative morbidity and mortality after esophagectomy and gastrectomy in the Netherlands according to the definitions of the Esophagectomy Complications Consensus Group (ECCG). Background: To standardize international outcome reporting in esophageal surgery, the ECCG developed a standardized outcomes set. Methods: For this national cohort study, all patients undergoing esophagectomy or gastrectomy for cancer between 2016 and 2017 were selected from the Dutch Upper gastrointestinal Cancer Audit. In a random sample of hospitals, data completeness and accuracy were validated by reabstraction of the data. The investigated outcomes in the present study were postoperative complications, major complications (Clavien-Dindo grade ≥III), and 30-day mortality, according to definitions of the ECCG. Results: A total of 2545 patients from 22 hospitals were included. The completeness of the Dutch Upper gastrointestinal Cancer Audit was estimated at 99.8%. Data accuracy on different items was 94% to 100%. After esophagectomy, 1046 of 1617 patients (65%) had a postoperative complication including 468 patients (29%) with a major complication. Most common complications were pneumonia (21%), esophago-enteric leak from anastomosis, staple line or localized conduit necrosis (19%), and atrial dysrhythmia (15%). The 30-day mortality was 1.7%. After gastrectomy, 397 of 928 patients (42%) had a postoperative complication including 180 patients (19%) with a major complication. Most common complications were pneumonia (12%), esophago-enteric leak from anastomosis, staple line or localized conduit necrosis (9%), and acute delirium (5%). The 30-day mortality was 4.4%. Conclusions: Reporting complications according to the ECCG platform is feasible in the Netherlands and facilitates international benchmarking. [ABSTRACT FROM AUTHOR]