CARE-radiology statement explanation and elaboration: reporting guideline for radiological case reports.

Despite the increasing number of radiological case reports, the majority lack a standardised methodology of writing and reporting. We therefore develop a reporting guideline for radiological case reports based on the CAse REport (CARE) statement. We established a multidisciplinary group of experts, comprising 40 radiologists, methodologists, journal editors and researchers, to develop a reporting guideline for radiological case reports according to the methodology recommended by the Enhancing the QUAlity and Transparency Of health Research network. The Delphi panel was requested to evaluate the significance of a list of elements for potential inclusion in a guideline for reporting mediation analyses. By reviewing the reporting guidelines and through discussion, we initially drafted 46 potential items. Following a Delphi survey and discussion, the final CARE-radiology checklist is comprised of 38 items in 16 domains. CARE-radiology is a comprehensive reporting guideline for radiological case reports developed using a rigorous methodology. We hope that compliance with CARE-radiology will help in the future to improve the completeness and quality of case reports in radiology.

The SUPER reporting guideline suggested for reporting of surgical technique: explanation and elaboration.

Background: Surgical technique plays an essential role in achieving good health outcomes. However, the quality of surgical technique reporting remains heterogeneous. Reporting checklists could help authors to describe the surgical technique more transparently and effectively, as well as to assist reviewers and editors evaluate it more informatively, and promote readers to better understand the technique. We previously developed SUPER (surgical technique reporting checklist and standards) to assist authors in reporting their research that contains surgical technique more transparently. However, further explanation and elaboration of each item are needed for better understanding and reporting practice. Methods: We searched surgical literature in PubMed, Google Scholar and journal websites published up to January 2023 to find multidiscipline examples in various article types for each SUPER item. Results: We explain the 22 items of the SUPER and provide rationales item by item alongside. We provide 69 examples from 53 literature that present optimal reporting of the 22 items. Article types of examples include pure surgical technique, and case reports, observational studies and clinical trials that contain surgical technique. Examples are multidisciplinary, including general surgery, orthopaedical surgery, cardiac surgery, thoracic surgery, gastrointestinal surgery, neurological surgery, oncogenic surgery, and emergency surgery etc. Conclusions: Along with SUPER article, this explanation and elaboration file can promote deeper understanding on the SUPER items. We hope that the article could further guide surgeons and researchers in reporting, and assist editors and peer reviewers in reviewing manuscripts related to surgical technique.

The SUPER reporting guideline suggested for reporting of surgical technique.

Background: Existing reporting guidelines pay insufficient attention to the detail and comprehensiveness reporting of surgical technique. The Surgical techniqUe rePorting chEcklist and standaRds (SUPER) aims to address this gap by defining reporting standards for surgical technique. The SUPER guideline intends to apply to articles that encompass surgical technique in any study design, surgical discipline, and stage of surgical innovation. Methods: Following the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach, 16 surgeons, journal editors, and methodologists reviewed existing reporting guidelines relating to surgical technique, reviewed papers from 15 top journals, and brainstormed to draft initial items for the SUPER. The initial items were revised through a three-round Delphi survey from 21 multidisciplinary Delphi panel experts from 13 countries and regions. The final SUPER items were formed after an online consensus meeting to resolve disagreements and a three-round wording refinement by all 16 SUPER working group members and five SUPER consultants. Results: The SUPER reporting guideline includes 22 items that are considered essential for good and informative surgical technique reporting. The items are divided into six sections: background, rationale, and objectives (items 1 to 5); preoperative preparations and requirements (items 6 to 9); surgical technique details (items 10 to 15); postoperative considerations and tasks (items 16 to 19); summary and prospect (items 20 and 21); and other information (item 22). Conclusions: The SUPER reporting guideline has the potential to guide detailed, comprehensive, and transparent surgical technique reporting for surgeons. It may also assist journal editors, peer reviewers, systematic reviewers, and guideline developers in the evaluation of surgical technique papers and help practitioners to better understand and reproduce surgical technique. Trial Registration: https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/#SUPER.

"Obesity paradox" has not an impact on minimally invasive anatomical lung resection.

INTRODUCTION: The paradoxical benefit of obesity, the 'obesity paradox', has been analyzed in lung surgical populations with contradictory results. Our goal was assessing the relationship of body mass index (BMI) to acute outcomes after minimally invasive major pulmonary resections. METHODS: Retrospective review of consecutive patients who underwent pulmonary anatomical resection through a minimally invasive approach for the period 2014-2019. Patients were grouped as underweight, normal, overweight and obese type I, II and III. Adjusted odds ratios regarding postoperative complications (overall, respiratory, cardiovascular and surgical morbidity) were produced with their exact 95% confidence intervals. All tests were considered statistically significant at p<0.05. RESULTS: Among 722 patients included in the study, 37.7% had a normal BMI and 61.8% were overweight or obese patients. When compared with that of normal BMI patients, adjusted pulmonary complications were significantly higher in obese type I patients (2.6% vs 10.6%, OR: 4.53 [95%CI: 1.86-12.11]) and obese type II-III (2.6% vs 10%, OR: 6.09 [95%CI: 1.38-26.89]). No significant differences were found regarding overall, cardiovascular or surgical complications among groups. CONCLUSIONS: Obesity has not favourable effects on early outcomes in patients undergoing minimally invasive anatomical lung resections, since the risk of respiratory complications in patients with BMI≥30kg/m2 and BMI≥35kg/m2 is 4.5 and 6 times higher than that of patients with normal BMI.

The robotic surgery learning curve of a surgeon experienced in video-assisted thoracoscopic surgery compared with his own video-assisted thoracoscopic surgery learning curve for anatomical lung resections.

OBJECTIVES: Robotic surgery, although it shares some technical features with video-assisted thoracoscopic surgery (VATS), offers some advantages, such as ergonomic design and a 3-dimensional view. Thus, the learning curve for robotic lung resection could be expected to be shorter than that of VATS for surgeons who are proficient in VATS. The goal of this study was to analyse the robotic learning curve of a VATS experienced surgeon and to compare it to his own VATS learning curve for anatomical lung resections. METHODS: We conducted a retrospective observational study based on the prospectively recorded data of the first 150 anatomical lung resections performed with VATS (75 cases) and with the robotic (75 cases) approach by the same surgeon in our centre. Learning curves were analysed using the cumulative sum method to assess the trends for total operating time and surgical failure (intraoperative complications, conversion, technical postoperative complications and reintervention) across case sequences. Subsequently, using adequate statistical tests, we compared the postoperative outcomes in both groups. RESULTS: The median operating time was similar for both approaches (P = 0.401). Surgical failure rate was higher for the robotic cases (21.3% vs 12%; P = 0.125). Based on cumulative sum analyses, operating time decreased starting with case 34 in the VATS group and with case 32 in the robotic cohort. Surgical failure tended to decline starting with case 28 in the VATS group and with case 32 in the robotic group. Perioperative results were similar in both groups. CONCLUSIONS: When we compared robotic and VATS learning curves for anatomical lung resection, we did not find any differences. Postoperative outcomes were also similar with both approaches.

Similar outcomes after newly implemented rats approach compared to standard vats for anatomical lung resection. A propensity-score matched analysis.

INTRODUCTION: Outcomes after the introduction of surgical innovations can be impaired by learning periods. The aim of this study is to compare the short-term outcomes of a recently implemented RATS approach to a standard VATS program for anatomical lung resections. METHODS: Retrospective review of consecutive patients undergoing pulmonary anatomical resection through a minimally invasive approach since RATS approach was applied in our department (June 01, 2018, to November 30, 2019). Propensity score matching was performed according to patients' age, gender, ppoFEV1, cardiac comorbidity, type of malignancy, and type of resection. Outcome evaluation includes: overall morbidity, significant complications (cardiac arrhythmia, pneumonia, prolonged air leak, and reoperation), 30-day mortality, and length of hospital stay. Data were compared by two-sided chi-square or Fisher's exact test for categorical and Mann-Whitney U test for continuous variables. RESULTS: A total of 273 patients (206 VATS, 67 RATS) were included in the study. After propensity score matching, data of 132 patients were analyzed. The thirty-days mortality was nil. Overall morbidity (RATS: 22.4%, VATS: 29.2%; p=0.369), major complications (RATS: 9% vs VATS: 9.2%; p=0.956) and the rates of specific major complications (cardiac arrhythmia RATS: 4.5%, VATS: 4.6%, p=1; pneumonia RATS:0%, VATS:4.6%, p=0.117; prolonged air leak RATS: 7.5%; VATS: 4.6%, p=0.718) and reoperation (RATS: 3%, VATS: 1.5%, p=1) were comparable between both groups. The median length of stay was 3 days in both groups (p=0.101). CONCLUSIONS: A RATS program for anatomical lung resection can be implemented safely by experienced VATS surgeons without increasing morbidity rates.

Teaching non-technical skills: the patient centered approach.

The surgical setting is a highly complex environment where, in ideal conditions, everything should be under control to ensure a positive outcome. However, the existing complexity opens the possibility for multiple failures along the process and many of those failures are related to what is call the non-technical skills of the members of the team. We cannot eradicate human error, but we can try to avoid future mistakes in our daily practice introducing the awareness for providing a high-quality care in which patient safety is crucial. This paper presents an easy approach to concepts and teaching possibilities of those non-technical skills.

Quality Control in Anatomical Lung Resection. Major Postoperative Complications vs Failure to Rescue.

OBJECTIVES: Failure to rescue (FTR) is defined by the number of deaths among patients experiencing major complications after surgery. In this report we analyze FTR and apply a cumulative sum control chart (CUSUM) methodology for monitoring performance in a large series of operated lung carcinoma patients. METHODS: Prospectively stored records of cases undergoing anatomical lung resection in one center were reviewed. Postoperative adverse events were coded and included as a binary variable (major, or minor complications). The occurrence of 30-day mortality was also recorded. Patients dying after suffering major complications were considered as FTR. Risk-adjusted CUSUM graphs using EuroLung1 and 2 variables were constructed for major complications and FTR. Points of plateauing or trend inversion were checked to detect intentional or non-adverted changes in the process of care. RESULTS: 2237 cases included. 9.1% cases suffered major complications. The number of cases considered as failures to rescuing was 46 (2.1% of the total series and 22.5% of cases having major complications). The predictive performance of EuroLung1 and 2 models was as follows: EuroLung1 (major morbidity) C-index 0.70 (95%CI: 0.66-0.73); EuroLung2 (applied to FTR) C-index 0.81 (95%CI: 0.750.87). CUSUM graphs depicted improvement in rescuing complicated patients after case 330 but no improvement in the rate of non-complicated cases until case 720. CONCLUSIONS: FTR offers a complementary view to classical outcomes for quality assessment in Thoracic Surgery. Our study also shows how the analysis of FTR on time series can be applied to evaluate changes in team performance along time.

"Obesity paradox" has not an impact on minimally invasive anatomical lung resection.

INTRODUCTION: The paradoxical benefit of obesity, the 'obesity paradox', has been analyzed in lung surgical populations with contradictory results. Our goal was assessing the relationship of body mass index (BMI) to acute outcomes after minimally invasive major pulmonary resections. METHODS: Retrospective review of consecutive patients who underwent pulmonary anatomical resection through a minimally invasive approach for the period 2014-2019. Patients were grouped as underweight, normal, overweight and obese type I, II and III. Adjusted odds ratios regarding postoperative complications (overall, respiratory, cardiovascular and surgical morbidity) were produced with their exact 95% confidence intervals. All tests were considered statistically significant at p<0.05. RESULTS: Among 722 patients included in the study, 37.7% had a normal BMI and 61.8% were overweight or obese patients. When compared with that of normal BMI patients, adjusted pulmonary complications were significantly higher in obese type I patients (2.6% vs 10.6%, OR: 4.53 [95%CI: 1.86-12.11]) and obese type II-III (2.6% vs 10%, OR: 6.09 [95%CI: 1.38-26.89]). No significant differences were found regarding overall, cardiovascular or surgical complications among groups. CONCLUSIONS: Obesity has not favourable effects on early outcomes in patients undergoing minimally invasive anatomical lung resections, since the risk of respiratory complications in patients with BMI≥30kg/m2 and BMI≥35kg/m2 is 4.5 and 6 times higher than that of patients with normal BMI.

Similar outcomes after newly implemented rats approach compared to standard vats for anatomical lung resection. A propensity-score matched analysis.

INTRODUCTION: Outcomes after the introduction of surgical innovations can be impaired by learning periods. The aim of this study is to compare the short-term outcomes of a recently implemented RATS approach to a standard VATS program for anatomical lung resections. METHODS: Retrospective review of consecutive patients undergoing pulmonary anatomical resection through a minimally invasive approach since RATS approach was applied in our department (June 01, 2018, to November 30, 2019). Propensity score matching was performed according to patients' age, gender, ppoFEV1, cardiac comorbidity, type of malignancy, and type of resection. Outcome evaluation includes: overall morbidity, significant complications (cardiac arrhythmia, pneumonia, prolonged air leak, and reoperation), 30-day mortality, and length of hospital stay. Data were compared by two-sided chi-square or Fisher's exact test for categorical and Mann-Whitney U test for continuous variables. RESULTS: A total of 273 patients (206 VATS, 67 RATS) were included in the study. After propensity score matching, data of 132 patients were analyzed. The thirty-days mortality was nil. Overall morbidity (RATS: 22.4%, VATS: 29.2%; p=0.369), major complications (RATS: 9% vs VATS: 9.2%; p=0.956) and the rates of specific major complications (cardiac arrhythmia RATS: 4.5%, VATS: 4.6%, p=1; pneumonia RATS:0%, VATS:4.6%, p=0.117; prolonged air leak RATS: 7.5%; VATS: 4.6%, p=0.718) and reoperation (RATS: 3%, VATS: 1.5%, p=1) were comparable between both groups. The median length of stay was 3 days in both groups (p=0.101). CONCLUSIONS: A RATS program for anatomical lung resection can be implemented safely by experienced VATS surgeons without increasing morbidity rates.

Women in thoracic surgery: European perspectives.

During the last decades, women have been discouraged from entering the medical career and in particular in the surgical specialties. This situation is changing across continents and national and international initiatives are supporting aspiring female surgeons in pursuing the surgical career through mentorship and fellowship programmes. Due to the differences in training programmes, Health Care systems and cultural backgrounds, it's not easy to describe unanimously the pathways and obstacles that junior female thoracic surgeons are experiencing in Europe. The development of female surgical associations, mentorship programmes and national initiatives will further champion the gender equality in this specialty across Europe. During the recent years, the European Society of Thoracic Surgeons (ESTS) has established initiatives like the first ESTS Women in Thoracic Surgery Scientific Session or the annual Women in Thoracic ESTS Reception during the Annual Conference, which are done in an effort to encourage all female colleagues to join this specialty and increase the opportunity to share their experience and meet potential mentors. In this article we will depict the situation in some of the European countries whose female thoracic surgeons have led their way. We aim to give the next generation the examples that can influence women's choice of surgical career, and the possible strategies and initiatives to reduce the gender discrimination within healthcare.

Evidence on reporting guidelines for surgical technique in clinical disciplines: a scoping review protocol.

BACKGROUND: The reporting of surgical techniques is of mixed quality, with most at a very minimal level. Reporting guidelines that could be applied to guide surgical technique reporting vary in methodology for development, discipline coverage, dimension coverage and detail requested. However, a scoping review that could indicate the gaps and efforts needed in surgical technique reporting guidelines is lacking and warranted. This study aims to design a methodological rigour protocol to guide the development of a scoping review of surgical technique reporting guidelines. METHODS: This protocol is designed following the 2020 manual proposed by the Joanna Briggs Institute. To further ensure the soundness of the protocol, we also included multidisciplinary professionals (including methodologists, clinicians, and journal editors) to refine the protocol. DISCUSSION: Seven key steps for developing the scoping review are identified and presented in detail, including (I) identifying the research questions; (II) inclusion criteria; (III) search strategy; (IV) source of evidence selection; (V) data extraction; (VI) analysis of the evidence; and (VII) presentation of the results. Guided by this protocol, the subsequent scoping review will inform us the overview of surgical technique reporting guidelines and precisely guide our direction and next steps in improving surgical technique reporting guidelines. TRIAL REGISTRATION: This protocol is not registered as the PROSPERO database only accepts registration of systematic review protocols while does not accept registration of scoping review protocols.

Developing the surgical technique reporting checklist and standards: a study protocol.

BACKGROUND: Standardized and transparent reporting of surgical technique is the cornerstone of effective dissemination, implementation and improvement. However, current reporting of surgical techniques is inadequate. The existing guidelines potentially applied to guide surgical technique reporting are with a minimal highlight of the surgical technique, lack requirements explaining what extent and dimensions need to be described in detail, or are unlikely to extrapolate to a wide range of surgical techniques. This study aims to formulate a rigorous protocol to develop a surgical technique reporting checklist and standards (SUPER) that defines what a clear, comprehensive and detailed surgical technique report should be contained. METHODS: This protocol is designed following the classic guidance for developing reporting guidelines recommended by the EQUATOR network. RESULTS: The development team will consist of surgeons (~80%), methodologists, and journal editors. The draft checklist sources will include a scoping review of existing reporting guidelines related to surgical technique, surgical technique articles from 15 top journals published in the last year, and brainstorming by the multidisciplinary development team. The final SUPER checklist will be formed after three rounds of Delphi surveys, one round of face-to-face meeting, and a month-long pilot test. The SUPER checklist will be published as open-access and be used in combination with existing reporting guidelines related to surgical techniques (e.g., IDEAL). This protocol will steer the SUPER checklist's development, allowing us to further elaborate surgical technique reporting for all surgical specialties, and enabling a more favorable experience for surgeons, nurses, medical students, residents, editors, and reviewers. TRIAL REGISTRATION: This trial is registered at the EQUATOR network on December 18th, 2020. Available at: https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/.

Monitoring surgical quality: the cumulative sum (CUSUM) approach.

Monitoring the quality of new or ongoing surgical activities is a necessity. Several Statistical Process Control (SPC) tools are available to professionals. Among them, Shewhart charts and cumulative sum charts (CUSUM charts) are useful methods to provide visual feedback before significant quality issues arise. In this paper, we discuss both methods based on our current approach. On Shewhart charts, one variable value is plotted on a time-series line. This method provides information about every single determination. Random variations of the values appear and by adjusting the adequate control limits it is possible to know whether those variations are random or out-of-control. Although large variations are easily detected, small but relevant changes are not. On the contrary, CUSUM charts have the capability of detecting small changes quickly. CUSUM is defined as a statistical tool that graphically represents the sequential monitoring of cumulative performance of any dichotomized or continuous variable under assessment. It emphasizes failures penalizing them against the correct performance when individual risk is adjusted. This makes CUSUM especially sensitive to negative changes. CUSUM can be created without the need of a specific sample size and grow with every new case included. Besides the variable under control (with specific definitions of acceptable and unacceptable outcomes), the type I and II errors for the defined parameter and the individual risk of acceptable or unacceptable outcomes must be included in the chart. Graphical representation of these three parameters is easy and intuitive to read making CUSUM graphs a reliable tool to understand the trending of the parameter under control. If performance is considered inadequate: analysis, discussion and implementation of agreed measures should be taken. Despite its limitations, CUSUM analysis is considered the best tool for quality control in health care domain.

Fibrin sealant for esophageal anastomosis: A phase II study.

BACKGROUND: Esophagectomy is a pivotal curative modality for localized esophageal or esophagogastric junction cancer (EC or EJC). Postoperative anastomotic leakage (AL) remains problematic. The use of fibrin sealant (FS) may improve the strength of esophageal anastomosis and reduce the incidence of AL. AIM: To assess the efficacy and safety of applying FS to prevent AL in patients with EC or EJC. METHODS: In this single-arm, phase II trial (Clinicaltrial.gov identifier: NCT03529266), we recruited patients aged 18-80 years with resectable EC or EJC clinically staged as T1-4aN0-3M0. An open or minimally invasive McKeown esophagectomy was performed with a circular stapled anastomosis. After performing the anastomosis, 2.5 mL of porcine FS was applied circumferentially. The primary endpoint was the proportion of patients with AL within 3 mo. RESULTS: From June 4, 2018, to December 29, 2018, 57 patients were enrolled. At the data cutoff date (June 30, 2019), three (5.3%) of the 57 patients had developed AL, including two (3.5%) with esophagogastric AL and one (1.8%) with gastric fistula. The incidence of anastomotic stricture and other major postoperative complications was 1.8% and 17.5%, respectively. The median time needed to resume oral feeding after operation was 8 d (Interquartile range: 7.0-9.0 d). No adverse events related to FS were recorded. No deaths occurred within 90 d after surgery. CONCLUSION: Perioperative sealing with porcine FS appears safe and may prevent AL after esophagectomy in patients with resectable EC or EJC. Further phase III studies are warranted.

Early exercise pulmonary diffusing capacity of carbon monoxide after anatomical lung resection: a word of caution for fast-track programmes.

OBJECTIVES: In healthy individuals, increasing pulmonary blood flow during exercise also increases the % of the diffusing capacity of the lungs for carbon monoxide (DLCO%), but its evolution after lung resection is unknown. In this study, our goal was to measure changes in exercise DLCO% during the first 3 days after anatomical lung resection. METHODS: We performed a prospective observational study on consecutive patients with non-small-cell lung cancer scheduled for anatomical resection, except pneumonectomy, during a 6-month period. Patients underwent measurement of the DLCO% by a single-breath technique adjusted by the concentration of haemoglobin-before and after standardized exercise the day before and 3 consecutive days after surgery. The delta (Δ) variation (basal versus exercise) was calculated. The number of functioning resected segments was calculated by bronchoscopy. Postoperative pain and pleural air leak were estimated using a visual analogue scale and graduated conventional pleural drainage systems, respectively, and their influence on ΔDLCO each postoperative day was evaluated by linear regression analysis. RESULTS: Fifty-seven patients were included. The visual analogue scale of pain and pleural air leaks were not correlated to Δ values (model R2: 0.0048). The evolution of Δ values during 3 postoperative days showed a progressive recovery of values, but on the third day, DLCO% capacity during exercise was still impaired (P < 0.01), especially in patients who underwent a resection of more than 3 functioning segments. CONCLUSIONS: Physiological increase in DLCO% during exercise is still impaired on the third postoperative day in patients undergoing resection of more than 3 functioning pulmonary segments. This fact should be considered before discharging those patients after anatomical lung resection.

Future trends in preoperative evaluation.

Preoperative evaluation before lung resection has been frequently addressed in modern medical literature. Actual or predicted pulmonary volumes are considered relevant to predict the risk of surgery. Nevertheless, ppoFEV1 underestimates the real functional loss in the immediate postoperative period when most of the complications occur. Not all patients, however, have comparable functional changes after lobectomy. Minimal impairment or even improvements have been demonstrated in COPD cases after lobectomy. Efforts should be directed to an accurate prediction of the immediate postoperative pulmonary volumes for a better evaluation of high-risk patients caused by respiratory impairment. Future developments are needed on the role of measuring preoperative DLCO and how to evaluate a patient's general cardiorespiratory status. Evidence underlines the relevance of routine evaluation of preoperative DLCO at rest or, better, during exercise for a thorough assessment of patient's capability to adapt to a stressful situation (Fig. 3). Only by improving knowledge about the general condition of the patient, can one assess the physiologic response to surgery. Widespread use of sophisticated or simple exercise tests and measurements or daily activity using motion detectors can identify high-risk patients with otherwise acceptable pulmonary volumes. Another suggested investigation issue is to develop different relevant outcome parameters, not only from the surgeon's point of view but also from the patient's perspective, such as postoperative QOL-related variables or delayed outcomes. Finally, multidisciplinary investigation teams, including experts in mathematical modeling, are essential to improve the quality and validity of the developed models. Although knowledge about perioperative physiologic changes has increased, clinicians are still far from finding a way to put all this knowledge down and make it applicable for an individual patient. Multicentric cooperation and evaluation of large prospectively recorded databases are essential to develop evidence-based clinical guidelines on preoperative evaluation.

[Results of surgery for non-small cell lung cancer with N2 involvement unsuspected before thoracotomy]. / Resultados de la cirugía del carcinoma de pulmón no microcítico con afectación N2 no sospechada antes de la toracotomía.

OBJECTIVE: To analyze survival in a group of patients with N2 involvement discovered during or after lung resection for non-small cell lung cancer and to evaluate the variables that affect survival. PATIENTS AND METHODS: The study included all patients with non-small cell lung cancer who underwent resection between January 1994 and October 2004 and in whom the definitive tumor classification was stage spIIIA due to N2 extension (n=74). Patients with stage spIIIB undergoing induction chemotherapy and patients for whom surgery was considered incomplete were excluded. RESULTS: Mean survival times were significantly different (P=.002) between resection types: pneumonectomy, 18.1 months (95% confidence interval [CI], 6.9-29.2 months), and lobectomy, 42.4 months (95% CI, 28.7-56.1 months). The number of lymph-node stations affected did not have a significant effect on survival. However, when only 1 station was involved, mean survival was different for lobectomy and pneumonectomy (48.0 months [95% CI, 31-65 months] vs 14.8 months [95% CI, 4.8-24.7 months], respectively; P=.002) but no differences were found when N2 spread involved more than a single station. Adjuvant therapy was used in 50% of cases (n=35): chemotherapy in 6 cases; radiotherapy in 17 cases; and both in 12 cases. The mean survival rate for lobectomy patients with no adjuvant therapy was 31.6 months (95% CI, 15.6-47.5 months) and 46.2 months (95% CI, 32.2-60.1 months) (P=.01) with adjuvant therapy, whereas there were no differences in the group of pneumonectomy patients. CONCLUSIONS: Patients who undergo lobectomy clearly survive longer than those who undergo pneumonectomy when N2 lymph node involvement is found in only 1 station during surgery. Furthermore, adjuvant therapy may increase mean survival times for lobectomy patients.

Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial.

Purpose The efficacy of neoadjuvant chemoradiotherapy (NCRT) plus surgery for locally advanced esophageal squamous cell carcinoma (ESCC) remains controversial. In this trial, we compared the survival and safety of NCRT plus surgery with surgery alone in patients with locally advanced ESCC. Patients and Methods From June 2007 to December 2014, 451 patients with potentially resectable thoracic ESCC, clinically staged as T1-4N1M0/T4N0M0, were randomly allocated to NCRT plus surgery (group CRT; n = 224) and surgery alone (group S; n = 227). In group CRT, patients received vinorelbine 25 mg/m2 intravenously (IV) on days 1 and 8 and cisplatin 75 mg/m2 IV day 1, or 25 mg/m2 IV on days 1 to 4 every 3 weeks for two cycles, with a total concurrent radiation dose of 40.0 Gy administered in 20 fractions of 2.0 Gy on 5 days per week. In both groups, patients underwent McKeown or Ivor Lewis esophagectomy. The primary end point was overall survival. Results The pathologic complete response rate was 43.2% in group CRT. Compared with group S, group CRT had a higher R0 resection rate (98.4% v 91.2%; P = .002), a better median overall survival (100.1 months v 66.5 months; hazard ratio, 0.71; 95% CI, 0.53 to 0.96; P = .025), and a prolonged disease-free survival (100.1 months v 41.7 months; hazard ratio, 0.58; 95% CI, 0.43 to 0.78; P < .001). Leukopenia (48.9%) and neutropenia (45.7%) were the most common grade 3 or 4 adverse events during chemoradiotherapy. Incidences of postoperative complications were similar between groups, with the exception of arrhythmia (group CRT: 13% v group S: 4.0%; P = .001). Peritreatment mortality was 2.2% in group CRT versus 0.4% in group S ( P = .212). Conclusion This trial shows that NCRT plus surgery improves survival over surgery alone among patients with locally advanced ESCC, with acceptable and manageable adverse events.