Objective To summarize the progress and trend on clinical drug trials of esophageal squamous cell carcinoma in China. Methods Based on the clinical drug trial registration and information disclosure platform and the drug data query system of the National Medical Products Administration, the characteristics of clinical trials, investigational drugs and listed drugs of esophageal squamous cell carcinoma in China from 2012 to 2021 were analyzed. Results From 2012 to 2021, a total of 49 clinical drug trials of esophageal squamous cell carcinoma were registered in China, accounting for 1.6% of all clinical trials of anticancer drugs. Among them, there were 39 (79.6%) trials initiated by domestic pharmaceutical enterprises, 6 (12.2%) for adjuvant and neoadjuvant treatment, and 9 (18.4%) for local treatment. There were differences in the treatment line distribution between global and domestic enterprise-initiated trials (P=0.032). The above trials covered 29 investigational drugs, including 23 (79.3%) targeted drugs, most of which targeted programmed death-1, programmed death-ligand 1 and epidermal growth factor receptor. From 2012 to 2021, there were 2 drugs for esophageal squamous cell carcinoma listed in China, both of which were approved for the first-line and second- line treatment. Conclusion Great achievements have been made in the clinical development of esophageal squamous cell carcinoma drugs in China. It is suggested that domestic enterprises increase the investment of esophageal squamous cell carcinoma, pay attention to adjuvant and local treatment, explore novel targets and drug categories, and focus on the details of pivotal trials.
ObjectiveTo investigate the predictive value of prognostic nutritional index (PNI) in complications after thoracoscopy-assisted radical resection of esophageal cancer.MethodsWe collected the clinical data of patients who underwent thoracoscopy-assisted esophagectomy in the First Affiliated Hospital of Xinjiang Medical University from January 2015 to June 2020. The predictive value of PNI for postoperative complications was evaluated by establishing receiver operating characteristic (ROC) curve and the optimal cut-off point was determined. The patients were divided into a high PNI group and a low PNI group according to the cut-off point. The differences of baseline data and perioperative complications-related indicators between the two groups were compared and analyzed. Univariate and multivariate analyses were used to investigate the influence of PNI and other related indexes on postoperative complications.ResultsA total of 116 patients were enrolled in this study, including 75 males and 41 females, aged 65 (58-69) years. The area under ROC curve was 0.647, and the optimal cut-off point was 51.9. According to the cut-off point, there were 45 patients in the high PNI group and 71 patients in the low PNI group. The overall complication rate (χ2=10.437, P=0.001) and the incidence of postoperative pulmonary infection (χ2=10.811, P=0.001) were statistically different between the two groups. The results of univariate analysis showed that the duration of ventilator use (Z=–3.136, P=0.002), serum albumin value (t=2.961, P=0.004), and PNI value (χ2=10.437, P=0.001) were the possible risk factors for postoperative complications after thoracoscopy-assisted esophagectomy. The results of multivariate analysis suggested that the duration of ventilator use (OR=1.015, P=0.002) and the history of drinking (OR=5.231, P=0.013) were independent risk factors for postoperative complications, and high PNI was the protective factor for postoperative complications (OR=0.243, P=0.047).ConclusionPNI index has a certain value in predicting postoperative complications, which can quantify the preoperative nutritional and immune status of patients. Drinking history and duration of ventilator use are independent risk factors for postoperative complications of thoracoscopy-assisted esophagectomy, and high PNI is a protective factor for postoperative complications.
With the continuous advancement and development of minimally invasive techniques, uniportal thoracoscopic minimally invasive esophagectomy (UTMIE) has gradually expanded its application in the surgical treatment of esophageal cancer due to its significant advantages, including minimal trauma, aesthetically pleasing incisions, and reduced postoperative pain. This consensus is based on the latest evidence-based medical data from both domestically and internationally, combined with extensive clinical practice experiences from numerous experts. It systematically reviews and summarizes the indications, key technical points, learning curve characteristics, perioperative management strategies, as well as prevention and management of complications associated with UTMIE. To ensure the scientific rigor and authority of this consensus, a total of 83 experts in the field were invited to participate in multiple rounds of Delphi surveys for in-depth discussion and consultation. Ultimately, 24 recommendations were formulated to guide the standardized application of UTMIE in clinical practice. The aim of this consensus is to standardize and guide the clinical implementation of UTMIE, ensuring safety and efficacy while promoting more efficient and widespread development of this surgical approach.
As a core biomarker of non-invasive liquid biopsy, circulating tumor DNA (ctDNA) provides a breakthrough approach for minimal residual disease (MRD) monitoring in esophageal cancer. Esophageal cancer is clinically characterized by strong invasiveness, high postoperative recurrence rate, and poor prognosis. Traditional imaging and histopathological examinations are difficult to meet the clinical demand for accurate MRD identification due to limitations such as insufficient sensitivity and high invasiveness. This paper systematically reviews the biological basis and technical advances of ctDNA detection, focusing on the advantages and clinical application scenarios of core technologies including digital polymerase chain reaction, next-generation sequencing, and methylation detection. It further analyzes the core clinical value of ctDNA in esophageal cancer MRD monitoring, covering key directions such as early recurrence warning, dynamic evaluation of treatment efficacy, and optimization of individualized treatment strategies. Meanwhile, the main challenges currently faced, including insufficient technical standardization, interference from tumor heterogeneity, and lag in clinical translation, are discussed, and future development trends such as multi-omics integration and artificial intelligence-assisted diagnosis are prospected. This review aims to provide an academic reference for the precise clinical management of esophageal cancer MRD, promote the standardized application and translation of ctDNA technology in clinical practice of cardiothoracic surgery, and ultimately improve the survival prognosis of patients.
ObjectiveTo investigate the effect of the interval between neoadjuvant chemoradiotherapy (nCRT) and surgery on the clinical outcome of esophageal cancer.MethodsPubMed and EMbase databases from inception to March 2018 were retrieved by computer. A random-effect model was used for all meta-analyses irrespective of heterogeneity. The meta-analysis was performed by RevMan5.3 software. The primary outcomes were operative mortality, incidence of anastomotic leakage, and overall survival; secondary outcomes were pathologic complete remission rate, R0 resection rate, and positive resection margin rate.ResultsA total of 17 studies with 18 173 patients were included. Among them, 13 were original studies with 2 950 patients, and 4 were database-based studies with a total of 15 223 patients. The results showed a significant positive correlation between the interval and operative mortality (Spearman coefficient=0.360, P=0.027). Dose-response meta-analysis revealed that there was a relatively better time window for surgery after nCRT. Further analysis for primary outcomes at different time cut-offs found the following results: (1) when the time cut-off point within 30-70 days, the shorter interval was associated with a reduced operative mortality (7-8 weeks: RR=0.67, 95% CI 0.55-0.81, P<0.05; 30-46 days: RR=0.63, 95%CI 0.47-0.85, P<0.05; 60-70 days: RR=0.64, 95%CI 0.48-0.85, P<0.05); (2) when the time cut-off point within 30-46 days, the shorter interval correlated with a reduced incidence of anastomotic leakage (RR=0.39, 95%CI 0.21-0.72, P<0.05); when the time cut-off point within 7-8 weeks, the shorter interval could achieve a critical-level effect of reducing the incidence of anastomotic leakage (RR=0.73, 95%CI 0.52-1.03, P>0.05); (3) when the time cut-off point within 7-8 weeks, increased interval significantly was associated with the poor overall survival (HR=1.17, 95% CI 1.00-1.36, P<0.05). Secondary outcomes found that the shorter interval could significantly reduce the positive resection margin rate (RR=0.53, 95% CI 0.38-0.75, P<0.05) when time cut-off point within 56-60 days.ConclusionShortening the interval between nCRT and surgery can reduce the operative mortality, the incidence of anastomotic leakage, long-term mortality risk, and positive resection margin rate. It is recommended that surgery should be performed as soon as possible after the patient's physical recovery, preferably no more than 7-8 weeks, which supports the current study recommendation (within 3-8 weeks after nCRT).
Objective
To investigate the short-term postoperative pain between robot-assisted and thoracolaparoscopic McKeown esophagectomy for esophageal carcinoma.
Methods
We prospectively analyzed clinical data of 77 patients with esophageal carcinoma in our hospital between September 2016 and February 2017. The patients were allocated into two groups including a robot group and a thoracolaparoscopic group. The patients underwent robot assisted McKeown esophagectomy in the robot group and thoracolaparoscopic McKeown esophagectomy in the thoracolaparoscopic group. There were 38 patients with 30 males and 8 females at average age of 60.80±6.20 years in the thoracolaparoscopic group, and 39 patients with 35 males and 4 females at average age of 60.90±7.20 years in the robot group.
Results
There was no statistical difference between the two groups in terms of the postoperative usage of analgesic drugs. The patients in the robot group experienced less postoperative pain on postoperative day 1, 3, 5, 6 and 7 than the patients in the thoracolaparoscopic group. The mean value of visual analogue scale (VAS) on postoperative day 1, 3, 5, 6 and 7 for the robot group and the thoracolaparoscopic group was 3.20±1.10 versus 2.70±0.90 (P=0.002), 2.75±0.96 versus 2.40±0.98 (P=0.030), 2.68±1.08 versus 2.02±0.8 (P=0.005); 2.49±0.99 versus 1.81±0.88 (P=0.003), 2.27±0.83 versus 1.51±0.61 (P<0.001), respectively.
Conclusion
Compared with the thoracolaparoscopic group, patients receiving robot assisted McKeown esophagectomy experience less postoperative short-term pain. However, the long-term postoperative pain for these patients needs to be further studied.
ObjectiveTo investigate the safety and effectiveness of near-infrared fluorescence imaging of the thoracic duct (NFITD) using indocyanine green (ICG) during inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) for esophageal cancer. MethodsA retrospective analysis was conducted on patients with esophageal cancer who underwent IVMTE at the Department of Thoracic Surgery, the First Affiliated Hospital of University of Science and Technology of China, from January 2024 to October 2024. Patients were divided into two groups based on whether they underwent NFITD: an ICG NFITD group (ITD group) and a non-ICG NFITD group (NITD group). Propensity score matching was used to balance confounding factors, and perioperative data and short-term follow-up results (within 6 months) of the two groups were compared. ResultsA total of 66 patients were included, of which 51 were males and 15 were females, with an average age of (70.9±7.2) years. In the comparison of general information between the two groups, the proportion of patients in the ITD group with preoperative chronic obstructive pulmonary disease was higher than that in the NITD group (P=0.044), and the proportion of patients with preoperative bronchiectasis was lower than that in the NITD group (P=0.035). After propensity score matching at a 1:1 ratio, a total of 15 pairs of patients were successfully matched. There was no statistically significant difference between the two groups in terms of intraoperative blood loss, postoperative hospital stay, complications, maximum tumor diameter, pT stage, pN stage, and pTNM stage (P>0.05). The 6-month postoperative follow-up results showed no statistically significant difference between the two groups in terms of anastomotic stricture, hoarseness, gastric paralysis, anastomotic leakage, and postoperative adjuvant treatment (P>0.05). ConclusionThe application of NFITD in IVMTE is safe and effective, with a thoracic duct visualization rate of 100.0%. Compared with NITD, ITD prolonged the operation time but increased the number and stations of lymph node dissection without increasing perioperative and short-term postoperative complications (within 6 months), making it worthy of further clinical promotion.
ObjectiveTo compare the short-and mid-term outcomes of patients with esophageal cancer after subtotal esophagectomy via thoracoscopy in lateral prone position, prone position, or left lateral position.
MethodsThis randomized prospectively controlled study was conducted in 121 patients receiving subtotal esophagectomy via thoracoscopy between January 2010 and February 2013. The patients were randomly assigned into three groups to underwent esophagectomy in lateral prone position, prone position, or left lateral position, respectively. Forty-three patients (24 males, 19 females, 61.5±1.5 years) underwent surgery in lateral prone position, 39 patients (21 males, 18 females, 63.2±1.7 years) in prone position and other 39 patients (22 males, 17 females, 60.1±1.6 years) in left lateral position. Esophagogastric anastomosis was performed in the left neck.
ResultsThe median operative time in the three groups was 232 (165-296) min, 230 (170-310) min, and 280 (190-380) min, respectively (P < 0.05). The median perioperative bleeding was 262 (185-330) ml, 275 (100-320) ml and 350 (120-560) ml, respectively (P > 0.05). The average number of harvested lymph nodes was 19.1 (9-26), 18.4 (11-23), 10.9 (6-21), respectively (P < 0.05). The postoperative medical complications occurred in 10, 9 and 11 patients in three groups, respectively, with no statistical difference. Twenty patients died in the lateral prone position group after a median follow-up period of 19.2 (6-31) months, 18 patients died in the prone position group after a median follow-up period of 20.7 (8-29) months, and 21 patients died in the left lateral position group after a median follow-up period of 18.5 (12-33) months.
ConclusionThe results confirm the feasibility and safety of this minimally invasive esophagectomy via thoracoscopy in lateral prone position, prone position, or left lateral position for patients with esophageal carcinoma. A possible advantage of lateral prone technique is that in case of an emergency, precious time could be saved in changing the position of the patient.
With the widespread application of minimally invasive esophagectomy, inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) has gradually become one of the alternative surgical methods for transthoracic esophagectomy due to less trama, fewer perioperative complications and better short-term efficacy. However, there is no uniform standard for surgical methods and lymph node dissection in medical centers that perform IVMTE, which affects the standardization and further promotion of IVMTE. Therefore, on the basis of fully consulting domestic and foreign literature, our team proposed an expert consensus focusing on IVMTE, in order to standardize the clinical practice, guarantee the quality of treatment and promote the development of IMVTE.
ObjectiveTo present the initial clinical experience of robot-assisted thoracoscopic esophagectomy for patients with esophageal cancer and to analyze the short-term outcomes of these patients.MethodsBetween February 2016 and December 2017, 148 patients with esophageal carcinoma underwent robotic esophagectomy and two-fields lymph node dissection. There were 126 males and 22 females at average age of 62.0±8.0 years. Demographic data, intraoperative characteristics and short-term surgical outcomes were collected and analyzed.Results106 patients underwent McKeown esophagectomy and 42 patients underwent Ivor-Lewis esophagectomy. The mean operation time was 336.0±76.0 min, the mean intraoperative blood loss was 130.0±89.0 ml, the mean number of lymph nodes removed was 21.0±8.0 and the mean length of postoperative hospital-stay was 12.0±7.2 days. Postoperative complications included anastomotic fistula (n=8, 5.4%), pulmonary infection (n=13, 8.7%), hoarseness (n=23, 15.5%), tracheoesophageal fistula (n=1, 0.7%), chylothorax (n=4, 2.7%) and incision infection (n=2, 1.4%). There was no intra-operational massive hemorrhage or in-hospital mortality.ConclusionBoth robot-assisted McKeown and Ivor-Lewis esophagectomy are safe and feasible with good early outcomes.
