Development of a reliable surgical quality assurance tool for gastrectomy in oncological trials.

BACKGROUND: Despite its recognized importance, there is currently no reliable tool for surgical quality assurance (SQA) of gastrectomy in surgical oncology. The aim of this study was to develop an SQA tool for gastrectomy and to apply this tool within the ADDICT Trial in order to assess the extent and completeness of lymphadenectomy. METHODS: The operative steps for D1+ and D2 gastrectomy have been previously described in the literature and ADDICT trial manual. Two researchers also performed fieldwork in the UK and Japan to document key operative steps through photographs and semi-structured interviews with expert surgeons. This provided the steps that were used as the framework for the SQA tool. Sixty-two photographic cases from the ADDICT Trial were rated by three independent surgeons. Generalizability (G) theory determined inter-rater reliability. D-studies examined the effect of varying the number of assessors and photographic series they rated. Chi-square assessed intra-rater reliability, comparing how the individual assessor's responses corresponded to their global rating for extent of lymphadenectomy. RESULTS: The tool comprised 20 items, including 19 anatomical landmarks and a global rating score. Overall reliability had G-coefficient of 0.557. Internal consistency was measured with a Cronbach's alpha score of 0.869 and Chi-square confirmed intra-rater reliability for each assessor as < 0.05. CONCLUSIONS: A photographic surgical quality assurance tool is presented for gastrectomy. Using this tool, the assessor can reliably determine not only the quality but also the extent of the lymphadenectomy performed based on remaining anatomy rather than the excised specimen.

Severe Dumping Symptoms Are Uncommon Following Transthoracic Esophagectomy But Significantly Decrease Health-Related Quality of Life in Long-Term, Disease-Free Survivors.

BACKGROUND: High-quality documentation of dumping symptoms after esophagectomy is currently limited. The aim of the study was to describe the incidence of symptoms associated with dumping syndrome and their relationship with health-related quality of life after esophagectomy. METHODS: The study cohort was identified from prospective IRB-approved databases from two high-volume esophagectomy centers. Patients that were alive and without evidence of recurrence in April 2018 completed the validated Dumping Symptom Rating Scale and health-related quality of life questionnaires. Compound dumping symptom score was created by combining the individual scores for severity and frequency for each symptom. RESULTS: In total, 171 patients who underwent esophagectomy 1995-2017 responded to the questionnaires, corresponding to a response rate of 77.0%. Median age was 66 years and median time from operation to survey was 5.5 years. Absent or mild problems in all nine dumping symptoms were reported by 94 (59.5%) patients; 19 (12.0%) patients reported moderate or severe problems in at least three symptoms, the most common being postprandial "need to lie down," "diarrhea," and "stomach cramps." Increasing compound dumping symptom score was associated with significantly decreased function scores in all aspects of health-related quality of life except physical functioning (P < 0.005). CONCLUSIONS: Esophagectomy has the potential to change long-term eating patterns; however, the majority of patients in the study did not have severe postoperative dumping symptoms. On the other hand, moderate-to-severe dumping symptoms, which were reported by 12% of patients in this study, were strongly associated with decreased health-related quality of life.

Cardiorespiratory Comorbidity and Postoperative Complications following Esophagectomy: a European Multicenter Cohort Study.

BACKGROUND: The impact of cardiorespiratory comorbidity on operative outcomes after esophagectomy remains controversial. This study investigated the effect of cardiorespiratory comorbidity on postoperative complications for patients treated for esophageal or gastroesophageal junction cancer. PATIENTS AND METHODS: A European multicenter cohort study from five high-volume esophageal cancer centers including patients treated between 2010 and 2017 was conducted. The effect of cardiorespiratory comorbidity and respiratory function upon postoperative outcomes was assessed. RESULTS: In total 1590 patients from five centers were included; 274 (17.2%) had respiratory comorbidity, and 468 (29.4%) had cardiac comorbidity. Respiratory comorbidity was associated with increased risk of overall postoperative complications, anastomotic leak, pulmonary complications, pneumonia, increased Clavien-Dindo score, and critical care and hospital length of stay. After neoadjuvant chemoradiotherapy, respiratory comorbidity was associated with increased risk of anastomotic leak [odds ratio (OR) 1.83, 95% confidence interval (CI) 1.11-3.04], pneumonia (OR 1.65, 95% CI 1.10-2.47), and any pulmonary complication (OR 1.52, 95% CI 1.04-2.22), an effect which was not observed following neoadjuvant chemotherapy or surgery alone. Cardiac comorbidity was associated with increased risk of cardiovascular and pulmonary complications, respiratory failure, and Clavien-Dindo score ≥ IIIa. Among all patients, forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio > 70% was associated with reduced risk of overall postoperative complications, cardiovascular complications, atrial fibrillation, pulmonary complications, and pneumonia. CONCLUSIONS: The results of this study suggest that cardiorespiratory comorbidity and impaired pulmonary function are associated with increased risk of postoperative complications after esophagectomy performed in high-volume European centers. Given the observed interaction with neoadjuvant approach, these data indicate a potentially modifiable index of perioperative risk.

Effects of intraoperative pyloric stretch procedure on outcomes after esophagectomy.

Various methods have been described to aid pyloric drainage in patients undergoing esophagectomy with gastric reconstruction. These techniques are intended to prevent delayed gastric empting following esophagectomy that can be associated with early morbidity and long-term functional complaints. The current study aims to review the safety and efficacy of a pyloric stretch procedure performed at the time of esophagectomy. To achieve this, a retrospective review of 100 consecutive patients undergoing esophagectomy during the period 2011-2016 was performed. Until May 2013, no patients received intraoperative pyloric intervention. After May 2013, all patients (N = 50) underwent intraoperative pyloric stretch procedure that involved bidirectional mechanical dilatation of the pylorus. Postoperative outcomes including result of routine oral contrast swallow and early morbidity were evaluated. Intraoperative pyloric stretching was performed safely and without local complications in all patients. Delayed gastric emptying was observed significantly less frequently in patients who received intraoperative pyloric stretching (48% vs. 22%, P = 0.006). No significant differences were observed in postoperative outcomes. When considering all patients as a single cohort, the presence of delayed gastric emptying was associated with significantly higher rates of postoperative pneumonia (71% vs. 45%, P = 0.010), cardiac complications (57% vs. 25%, P = 0.001) as well as longer hospital say (12 vs. 15 days, P < 0.001) and delay to free oral fluid intake (7 vs. 9 days, < 0.001). Binary logistic regression identified age and postoperative delayed gastric emptying as independent risk factors for postoperative pneumonia. In conclusion, this study has demonstrated the safety and efficacy an intraoperative pyloric stretch procedure for the prevention of delayed gastric emptying following esophagectomy.

Assessment of body composition and sarcopenia in patients with esophageal cancer: a systematic review and meta-analysis.

There has recently been increased interest in the assessment of body composition in patients with esophageal cancer for the purpose of nutritional evaluation and prognostication. This systematic review and meta-analysis intends to summarize and critically evaluate the current literature concerning the assessment of body composition in patients with esophageal cancer and to assess its potential implication upon early and late outcomes. A systematic literature search (up to August, 2017) was conducted for studies describing the assessment of body composition in patients with esophageal and gastroesophageal junctional cancer. Meta-analysis of postoperative outcomes including long-term survival was performed using random effects models. Twenty-nine studies reported the assessment of body composition in 3193 patients. Methods used to assess body composition in patients with esophageal cancer included computerized tomography (n = 18 studies), bioelectrical impedance analysis (n = 10), and dual-energy X-ray absorptiometry (n = 1). Significant variability was observed in regard to study design and the criteria used to define individual parameters of body composition. Sarcopenic patients had a higher incidence of postoperative pulmonary complications (7 studies, OR 2.03, 95% CI 1.32-3.11, P = 0.001) after esophagectomy. Meta-analysis of six studies presenting long-term outcomes after esophagectomy identified significantly worse survival in patients who were sarcopenic (HR 1.70, 95% CI 1.33- 2.17, P < 0.0001). The assessment of body composition has the potential to become a clinically useful tool that could support decision-making in patients with esophageal cancer. Current evidence is however weakened by inconsistencies in methods of assessing and reporting body composition in this patient group.

Effect of perioperative blood transfusion on the long-term survival of patients undergoing esophagectomy for esophageal cancer: a systematic review and meta-analysis.

Perioperative blood transfusion has been linked to poorer long-term survival in patients undergoing esophagectomy, presumably due to its potential immunomodulatory effects. This review aims to summarize existing evidence relating to the influence of blood transfusion on long-term survival following esophagectomy for esophageal cancer. A systematic literature search (up to February 2017) was conducted for studies reporting the effects of perioperative blood transfusion on survival following esophagectomy for esophageal cancer. Meta-analysis was used to summate survival outcomes. Twenty observational studies met the criteria for inclusion. Eighteen of these studies compared the outcomes of patients who received allogenic blood transfusion to patients who did not receive this intervention. Meta-analysis of outcomes revealed that allogenic blood transfusion significantly reduced long-term survival (HR = 1.49; 95% CI 1.26 to 1.76; P < 0.001). There appeared to be a dose-related response with patients who received ≥3 units of blood having lower long-term survival compared to patient who received between 0 and 2 units (HR = 1.59; 95% CI 1.31 to 1.93; P < 0.001). Two studies comparing patients who received allogenic versus autologous blood transfusion showed superior survival in the latter group. Factors associated with the requirement for perioperative blood transfusion included: intraoperative blood loss; preoperative hemoglobin; operative approach; operative time, and; presences of advanced disease. These findings indicate that perioperative blood transfusion is associated with significantly worse long-term survival in patients undergoing esophagectomy for esophageal cancer. Autologous donation of blood, meticulous intraoperative hemostasis, and avoidance of unnecessary transfusions may prevent additional deaths attributed to this intervention.

Multimodality treatment for esophageal adenocarcinoma: multi-center propensity-score matched study.

Background: The primary aim of this study was to compare survival from neoadjuvant chemoradiotherapy plus surgery (NCRS) versus neoadjuvant chemotherapy plus surgery (NCS) for the treatment of esophageal or junctional adenocarcinoma. The secondary aims were to compare pathological effects, short-term mortality and morbidity, and to evaluate the effect of lymph node harvest upon survival in both treatment groups. Methods: Data were collected from 10 European centers from 2001 to 2012. Six hundred and eight patients with stage II or III oesophageal or oesophago-gastric junctional adenocarcinoma were included; 301 in the NCRS group and 307 in the NCS group. Propensity score matching and Cox regression analyses were used to compensate for differences in baseline characteristics. Results: NCRS resulted in significant pathological benefits with more ypT0 (26.7% versus 5%; P < 0.001), more ypN0 (63.3% versus 32.1%; P < 0.001), and reduced R1/2 resection margins (7.7% versus 21.8%; P < 0.001). Analysis of short-term outcomes showed no statistically significant differences in 30-day or 90-day mortality, but increased incidence of anastomotic leak (23.1% versus 6.8%; P < 0.001) in NCRS patients. There were no statistically significant differences between the groups in 3-year overall survival (57.9% versus 53.4%; Hazard Ratio (HR)= 0.89, 95%C.I. 0.67-1.17, P = 0.391) nor disease-free survival (52.9% versus 48.9%; HR = 0.90, 95%C.I. 0.69-1.18, P = 0.443). The pattern of recurrence was also similar (P = 0.660). There was a higher lymph node harvest in the NCS group (27 versus 14; P < 0.001), which was significantly associated with a lower recurrence rate and improved disease free survival within the NCS group. Conclusion: The survival differences between NCRS and NCS maybe modest, if present at all, for the treatment of locally advanced esophageal or junctional adenocarcinoma. Future large-scale randomized trials must control and monitor indicators of the quality of surgery, as the extent of lymphadenectomy appears to influence prognosis in patients treated with NCS, from this large multi-center European study.