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476. PATIENTS WITH TRACHEOSTOMY HAVE HIGHER INCIDENCE OF ESOPHAGEAL REFLUX AND DON’T PRESENT TYPICAL SYMPTOMS 476. 气管切开术患者食管反流发生率较高,且无典型症状
IF 2.6 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-08-30 DOI: 10.1093/dote/doad052.258
E. T. Bianchi, Paulo Cardoso, S. Szachnowicz, A. Nasi, F. Tustumi, F. Seguro, A. Duarte, R. Sallum
Lung diseases have a strong relationship with gastroesophageal reflux disease (GERD). It has been previously demonstrated that conditions such as tracheal stenosis, asthma and even lung transplantation may worsen with reflux and these patients have few symptoms of GERD. With the COVID-19 pandemic, the number of people who needed mechanical ventilation and tracheostomy increased. Our objective was to demonstrate the prevalence of gastro-oesophageal reflux (GER) in patients with tracheostomy and describe its characteristics. Esophageal manometry and 24 h pH-metry was performed in 137 consecutive patients with a tracheostomy already in a chronic phase, independent of symptoms. Inquire on respiratory and digestive symptoms was also carried out at the time of the examination. Prevalence of gastroesophageal reflux was identified in this population and description of the groups with reflux and without it, as well as comparison between them. Of the 137 patients, 49 were male, the average age was 40.94 ± 17.3 and the BMI was 26.3 ± 4.85. The prevalence of GER was 45.2%. Characteristics were similar between the groups with and without reflux. In the reflux group, the mean DeMeester score was 36.5 ± 20.8 and the presence of lower sphincter hypotonia was found in 31% of the patients and was not correlated with reflux (p = 0.285). 48% had heartburn symptoms and only 30% had a combination of heartburn and regurgitation. There was no association with higher DeMeester score and presence of symptons (p = 0,14). The presence of tracheostomy is related to an increased prevalence of reflux, even without typical symptoms most of the time. The mechanism for this is still unknown, perhaps the altered respiratory dynamics has a role. These patients should be investigated with functional exams if they develop any condition that may be affected by reflux.
肺部疾病与胃食管反流病(GERD)有密切关系。先前有研究表明,气管狭窄、哮喘甚至肺移植等疾病可能会因反流而恶化,而这些患者几乎没有反流的症状。随着COVID-19大流行,需要机械通气和气管切开术的人数增加。我们的目的是证明胃食管反流(GER)在气管切开术患者中的患病率,并描述其特征。食道压力测量和24小时ph测量在137例连续的气管切开术患者已经处于慢性期,独立于症状。检查时还询问了呼吸道和消化系统症状。在该人群中确定了胃食管反流的患病率,并描述了有反流和无反流的组,以及它们之间的比较。137例患者中,男性49例,平均年龄40.94±17.3,BMI 26.3±4.85。GER患病率为45.2%。有反流和无反流组之间的特征相似。反流组平均DeMeester评分为36.5±20.8,31%的患者存在下括约肌张力低下,与反流无关(p = 0.285)。48%的人有烧心症状,只有30%的人同时有烧心和反流。与较高的DeMeester评分和出现症状没有关联(p = 0,14)。气管切开术与反流发生率增加有关,即使大多数时候没有典型症状。其机制尚不清楚,也许是呼吸动力学的改变起了作用。如果这些患者出现任何可能受反流影响的情况,应进行功能检查。
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引用次数: 0
340. LONG-TERM ONCOLOGIC OUTCOMES OF ESOPHAGEAL CANCER AFTER NEOADJUVANT CHEMORADIATION AND SINGLE-INCISION MINIMALLY INVASIVE ESOPHAGECTOMY 新辅助放化疗和单切口微创食管切除术后食管癌的长期肿瘤学结果
IF 2.6 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-08-30 DOI: 10.1093/dote/doad052.154
Y. Chen, Jang-Ming Lee
For locally advanced esophageal cancer, neoadjuvant chemoradiation therapy followed by esophagectomy is a widely accepted standard treatment. However, the preferable techniques for esophagectomy are still debatable. Multi-incision minimally invasive esophagectomy (MIE) had shown similar long-term oncologic outcomes with open esophagectomy, while it provided shorter hospital stay and less surgical pain due to its decreased wound size. Following the trend to minimize wounds, we developed single-incision MIE, with uniport thoracoscopy and single-incision laparoscopy. In this study, we presented the long-term oncologic outcomes of esophageal cancer after neoadjuvant chemoradiation and single-incision MIE and identified the risk factors for poor oncological outcomes. Materials and Methods: From 2008 to 2022, 573 patients with locally advanced esophageal cancer who received neoadjuvant chemoradiation followed by MIE at our institute were included. 254 of them underwent single-incision MIE. Kaplan–Meier analysis was used to calculate overall survival (OS) and progression free survival (PFS). Univariate and multivariate analyses were applied by Cox proportional hazard regression model. The 5-year OS of esophageal cancer with neoadjuvant chemoradiation and single-incision MIE was 62.5% (stage 0–1), 34.5% (stage 2), 31.1% (stage 3) and 13.1% (stage 4), while its 5-year PFS was 47.7% (stage 0–1), 33.2% (stage 2), 26.5% (stage 3) and 19.6% (stage 4) (Figure 1). For esophageal cancer treated with neoadjuvant chemoradiation and MIE, factors such as age ≤ 65, female, FEV1 > 80%, Single-incision MIE, operation time ≤ 500 min, lymph nodes retrieved>40, pathological cancer staging ≤2, clinical cancer staging ≤2 and negative resection margin were significantly predictive of improved overall survival (OS). After multivariate analysis, only age, FEV1, cancer staging (both pathological and clinical) and resection margin were independent risk factors for OS. For patients with advanced esophageal cancer, single-incision MIE after neoadjuvant chemoradiation is a feasible procedure with fair long-term oncological outcomes. Risk factors, such as age > 65, FEV1 ≤ 80%, pathological cancer staging >2, clinical cancer staging >2 and positive resection margin were independently predictive of poor OS.
对于局部晚期食管癌症,食管切除术后新辅助放化疗是一种广泛接受的标准治疗方法。然而,食管切除术的首选技术仍有争议。多切口微创食管切除术(MIE)显示出与开放式食管切除术相似的长期肿瘤学结果,但由于其伤口大小减小,它提供了更短的住院时间和更少的手术疼痛。为了尽量减少伤口,我们开发了单切口MIE,包括单孔胸腔镜和单切口腹腔镜。在这项研究中,我们介绍了癌症在新辅助放化疗和单切口MIE后的长期肿瘤结果,并确定了肿瘤结果不佳的危险因素。材料与方法:2008年至2022年,纳入我所573例局部晚期食管癌症患者行新辅助放化疗后MIE治疗。其中254例行单切口MIE。Kaplan-Meier分析用于计算总生存期(OS)和无进展生存期(PFS)。Cox比例风险回归模型采用单变量和多变量分析。采用新辅助放化疗和单切口MIE治疗癌症的5年OS分别为62.5%(0–1期)、34.5%(2期)、31.1%(3期)和13.1%(4期),而5年PFS分别为47.7%(0-1期),33.2%(2阶段)、26.5%(3阶段)和19.6%(4阶段)(图1)。对于接受新辅助放化疗和MIE治疗的癌症,年龄等因素 ≤ 65,女性,FEV1 > 80%,单切口MIE,手术时间 ≤ 500分钟,淋巴结恢复>40,病理癌症分期≤2,临床癌症分期≤2和阴性切除率显著预测总生存率(OS)的提高。经多因素分析,只有年龄、FEV1、癌症分期(病理和临床)和切除率是OS的独立危险因素。对于晚期癌症患者,新辅助化疗后单切口MIE是一种可行的手术,具有公平的长期肿瘤结果。风险因素,如年龄 > 65,发烧1 ≤ 80%,病理癌症分期>2,临床癌症分期>2和阳性切除率独立预测OS差。
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引用次数: 0
296. FIBRIN SEALANT FOR THE PREVENTION OF ANASTOMOTIC LEAKAGE AFTER ESOPHAGECTOMY: INTERIM REPORT OF A PROSPECTIVE, PHASE III, RANDOMIZED CONTROLLED STUDY 296. 纤维蛋白密封剂预防食管切除术后吻合口漏:一项前瞻性、iii期、随机对照研究的中期报告
IF 2.6 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-08-30 DOI: 10.1093/dote/doad052.124
Jiadi Wu, Zerui Zhao, Zhichao Li, Weizhao Huang, Geng Wang, Teng Mao, Wenqiang Lv, Lin Peng, Jiyang Chen
Anastomotic leakage (AL) is one of the most pernicious complications after esophagectomy for patients with esophageal or esophagogastric junction cancer (EC or EJC). The application of fibrin sealant (FS) may be advantageous for reducing the incidence of AL. This study aims to evaluate the safety and effectiveness of FS in preventing AL in patients undergoing McKeown esophagectomy. In this multicenter, prospective, randomized controlled trial, we planned to recruit 360 patients aged 18–75 years with resectable EC or EJC and the interim analysis was performed when the number of participants reaches 180. Patients assigned to the FS group received McKeown esophagectomy with 2.5 mL Bioseal applied to the cervical anastomosis, while patients in the control group received surgery alone. The primary endpoint was the incidence of cervical AL within the first 3 months postoperatively. From February 2019 to November 2021, 180 patients were recruited, with 89 in the FS group and 91 in the control group. There was no statistically difference between the incidence of AL between the two groups [6.7% (6/89) in the FS vs. 14.3% (13/91) in the control group, P = 0.16]. Complications was comparable (P = 0.76) between the FS group (42 of 89, 47.2%) and the control group (45 of 91, 49.5%). No adverse events related to FS or deaths occurred postoperatively. The application of Bioseal intraoperatively is feasible and does not increase the risk of complications, and its effectiveness for the prevention of AL needs to be revalidated after the completion of patient enrollment.
吻合口渗漏(AL)是食管或食管胃交界癌症(EC或EJC)患者食管切除术后最严重的并发症之一。纤维蛋白封闭剂(FS)的应用可能有利于降低AL的发生率。本研究旨在评估FS预防McKeown食管切除术患者AL的安全性和有效性。在这项多中心、前瞻性、随机对照试验中,我们计划招募360名18-75岁的可切除EC或EJC患者,当参与者人数达到180人时进行中期分析。FS组患者接受McKeown食管切除术,在颈部吻合处应用2.5 mL Bioseal,而对照组患者仅接受手术。主要终点是术后前3个月内宫颈AL的发生率。从2019年2月到2021年11月,招募了180名患者,其中FS组89名,对照组91名。两组AL的发生率无统计学差异[FS组为6.7%(6/89),对照组为14.3%(13/91),P = 并发症具有可比性(P = 0.76)。术后未发生与FS相关的不良事件或死亡。术中应用Bioseal是可行的,不会增加并发症的风险,其预防AL的有效性需要在患者登记完成后重新验证。
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引用次数: 0
349. TOTALLY MECHANICAL STAPLED SIDE-TO-SIDE VERSUS CIRCULAR END-TO-SIDE ANASTOMOSIS FOR MINIMALLY INVASIVE IVOR LEWIS ESOPHAGECTOMY: A MULTICENTER ANALYSIS 微创IVOR-LEWIS食管切除术中完全机械缝合侧端侧与环形端侧吻合的多中心分析
IF 2.6 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-08-30 DOI: 10.1093/dote/doad052.162
Hui-Jiang Gao, Xiangyang Yu, Shixin Hu, Chu-Jiang Huang, De-Long Du, Xin Yu, Zhen-Tao Yu, Kai Ma
Totally minimally invasive esophagectomy (TMIE) is increasingly used in treatment of patients with esophageal cancer. However, it is currently unknown if fully mechanical stapled side-to-side anastomosis for Ivor Lewis TMIE could be preferred for patients in whom both procedures are oncologically feasible. The study was performed in 2 high-volume China esophageal cancer centers between Feb 2015 through Dec 2022. Prospectively collected data from consecutive patients with esophageal cancer localized in the distal esophagus or gastroesophageal junction undergoing Ivor Lewis TMIE were included. The primary outcome parameter was anastomotic leakage requiring reintervention or reoperation. Secondary outcome parameters were operation characteristics, pathology results, complications, reoperations, length of stay, mortality, and overall survival (OS). 147 patients were included in this study. The incidence of anastomotic leakage requiring reintervention or reoperation was 12.9% after fully mechanical stapled side-to-side versus 11.8% after circular end-to-side anastomosis (P = 0.852). Fully mechanical stapled side-to-side Ivor Lewis esophagectomy was significantly associated with a lower incidence of anastomosis stricture (5.7% vs 17.1%, p = 0.032). Pulmonary complications (20.0% vs 23.7%), recurrent laryngeal nerve palsy (7.1% vs 5.3%), chyle leakage (10.0 vs 7.9%), atrial fibrillation (12.9 vs 13.2) and median hospital length of stay (12 vs 11 days) were comparable between the two arms (all P > 0.05). R0 resection rate was similar between the groups. Overall survival was comparable between the two arms (hazard ratio [HR], 0.81, 95% CI, 0.62–1.21, P = 0.208). The cumulative 5-year OS was 44.3% in the fully mechanical stapled side-to-side anastomosis arm, as compared with 39.5% in the circular end-to-side anastomosis arm. Compared to circular end-to-side anastomosis in patients in whom both procedures are oncologically feasible, there was no significant difference in the incidence of anastomotic leakage and other postoperative morbidity and OS with a fully mechanical stapled side-to-side anastomostic Ivor Lewis esophagectomy. Fully mechanical stapled side-to-side Ivor Lewis esophagectomy was significantly associated with a lower incidence of anastomosis stricture.
全微创食管切除术(TMIE)越来越多地应用于食管癌患者的治疗。然而,目前尚不清楚,对于两种手术方法在肿瘤上都可行的患者来说,Ivor Lewis TMIE的全机械侧对侧吻合是否更可取。该研究于2015年2月至2022年12月在中国两个高容量食管癌中心进行。前瞻性收集食管癌位于食管远端或胃食管交界处的连续患者进行Ivor Lewis TMIE。主要结局参数为吻合口漏,需要再干预或再手术。次要结局参数为手术特征、病理结果、并发症、再手术、住院时间、死亡率和总生存期(OS)。147例患者纳入本研究。全机械侧侧吻合术吻合口瘘发生率为12.9%,圆端侧吻合术吻合口瘘发生率为11.8% (P = 0.852)。全机械侧对侧Ivor Lewis食管切除术与较低的吻合口狭窄发生率显著相关(5.7% vs 17.1%, p = 0.032)。肺部并发症(20.0% vs 23.7%)、喉返神经麻痹(7.1% vs 5.3%)、乳糜漏(10.0 vs 7.9%)、心房颤动(12.9 vs 13.2)和住院时间中位数(12 vs 11天)在两组之间具有可比性(均P < 0.05)。两组间R0切除率相似。两组的总生存率相当(风险比[HR], 0.81, 95% CI, 0.62-1.21, P = 0.208)。全机械端侧吻合臂累计5年OS为44.3%,圆形端侧吻合臂累计5年OS为39.5%。与圆端侧吻合相比,两种方法在肿瘤上都可行的患者,全机械侧对侧吻合Ivor Lewis食管切除术在吻合口漏发生率和其他术后发病率及OS方面无显著差异。全机械侧对侧Ivor Lewis食管切除术与较低的吻合口狭窄发生率显著相关。
{"title":"349. TOTALLY MECHANICAL STAPLED SIDE-TO-SIDE VERSUS CIRCULAR END-TO-SIDE ANASTOMOSIS FOR MINIMALLY INVASIVE IVOR LEWIS ESOPHAGECTOMY: A MULTICENTER ANALYSIS","authors":"Hui-Jiang Gao, Xiangyang Yu, Shixin Hu, Chu-Jiang Huang, De-Long Du, Xin Yu, Zhen-Tao Yu, Kai Ma","doi":"10.1093/dote/doad052.162","DOIUrl":"https://doi.org/10.1093/dote/doad052.162","url":null,"abstract":"\u0000 \u0000 \u0000 Totally minimally invasive esophagectomy (TMIE) is increasingly used in treatment of patients with esophageal cancer. However, it is currently unknown if fully mechanical stapled side-to-side anastomosis for Ivor Lewis TMIE could be preferred for patients in whom both procedures are oncologically feasible.\u0000 \u0000 \u0000 \u0000 The study was performed in 2 high-volume China esophageal cancer centers between Feb 2015 through Dec 2022. Prospectively collected data from consecutive patients with esophageal cancer localized in the distal esophagus or gastroesophageal junction undergoing Ivor Lewis TMIE were included. The primary outcome parameter was anastomotic leakage requiring reintervention or reoperation. Secondary outcome parameters were operation characteristics, pathology results, complications, reoperations, length of stay, mortality, and overall survival (OS).\u0000 \u0000 \u0000 \u0000 147 patients were included in this study. The incidence of anastomotic leakage requiring reintervention or reoperation was 12.9% after fully mechanical stapled side-to-side versus 11.8% after circular end-to-side anastomosis (P = 0.852). Fully mechanical stapled side-to-side Ivor Lewis esophagectomy was significantly associated with a lower incidence of anastomosis stricture (5.7% vs 17.1%, p = 0.032). Pulmonary complications (20.0% vs 23.7%), recurrent laryngeal nerve palsy (7.1% vs 5.3%), chyle leakage (10.0 vs 7.9%), atrial fibrillation (12.9 vs 13.2) and median hospital length of stay (12 vs 11 days) were comparable between the two arms (all P > 0.05). R0 resection rate was similar between the groups. Overall survival was comparable between the two arms (hazard ratio [HR], 0.81, 95% CI, 0.62–1.21, P = 0.208). The cumulative 5-year OS was 44.3% in the fully mechanical stapled side-to-side anastomosis arm, as compared with 39.5% in the circular end-to-side anastomosis arm.\u0000 \u0000 \u0000 \u0000 Compared to circular end-to-side anastomosis in patients in whom both procedures are oncologically feasible, there was no significant difference in the incidence of anastomotic leakage and other postoperative morbidity and OS with a fully mechanical stapled side-to-side anastomostic Ivor Lewis esophagectomy. Fully mechanical stapled side-to-side Ivor Lewis esophagectomy was significantly associated with a lower incidence of anastomosis stricture.\u0000 \u0000","PeriodicalId":11354,"journal":{"name":"Diseases of the Esophagus","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2023-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43793889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
200. COMPARISON OF SHORT-TERM OUTCOMES BETWEEN TRANSTHORACIC AND ROBOT-ASSISTED TRANSMEDIASTINAL RADICAL SURGERY FOR ESOPHAGEAL CANCER: A PROSPECTIVE STUDY 食管癌经胸和机器人辅助经舒张期根治术的短期疗效比较:一项前瞻性研究
IF 2.6 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-08-30 DOI: 10.1093/dote/doad052.061
Shuntaro Yoshimura, Y. Seto
The present study aimed to assess the lower invasiveness of robot-assisted transmediastinal radical esophagectomy by prospectively comparing this procedure with transthoracic esophagectomy in terms of perioperative outcomes, serum cytokine levels, and respiratory function after surgery for esophageal cancer. Patients who underwent a robot-assisted transmediastinal esophagectomy or transthoracic esophagectomy between April 2015 and March 2017 were included. The perioperative outcomes, preoperative and postoperative serum IL-6, IL-8, and IL-10 levels, and respiratory function measured preoperatively and at 6 months postoperatively were compared in patients with a robot-assisted transmediastinal esophagectomy and those with a transthoracic esophagectomy. Sixty patients with esophageal cancer were enrolled. The transmediastinal esophagectomy group had a significantly lower incidence of postoperative pneumonia (p = 0.002) and a significantly shorter postoperative hospital stay (p < 0.0002). The serum IL-6 levels on postoperative days 1, 3, 5, and 7 were significantly lower in the transmediastinal esophagectomy group (p = 0.005, 0.0007, 0.022, 0.020, respectively). In the latter group, the serum IL-8 level was significantly lower immediately after surgery and on postoperative day 1 (p = 0.003, 0.001, respectively) while the serum IL-10 level was significantly lower immediately after surgery (p = 0.041). The reduction in vital capacity, percent vital capacity, forced vital capacity, and forced expiratory volume at 1.0 s 6 months after surgery was significantly greater in the transthoracic esophagectomy group (p < 0.0001 for all four measurements). Although further, large-scale studies are needed to confirm our findings, robot-assisted transmediastinal esophagectomy may confer short-term benefits in radical surgery for esophageal cancer.
本研究旨在通过前瞻性比较机器人辅助的经纵隔根治性食管切除术与经胸食管切除术的围手术期预后、血清细胞因子水平和食管癌术后呼吸功能,来评估机器人辅助的经纵隔根治性食管切除术的低侵入性。研究纳入了2015年4月至2017年3月期间接受机器人辅助的经纵隔食管切除术或经胸食管切除术的患者。比较机器人辅助的经纵隔食管切除术和经胸食管切除术患者的围手术期结局、术前和术后血清IL-6、IL-8和IL-10水平以及术后6个月的呼吸功能。60名食管癌患者入选。经纵隔食管切除术组术后肺炎发生率显著降低(p = 0.002),术后住院时间显著缩短(p < 0.0002)。经纵隔食管切除术组患者术后第1、3、5、7天血清IL-6水平显著低于对照组(p分别为0.005、0.0007、0.022、0.020)。后者组术后即刻及术后第1天血清IL-8水平显著降低(p = 0.003、0.001),术后即刻血清IL-10水平显著降低(p = 0.041)。经胸食管切除术组术后1.0 ~ 6个月肺活量、肺活量百分比、用力肺活量和用力呼气量的降低显著大于经胸食管切除术组(所有四项测量值p < 0.0001)。虽然需要进一步的大规模研究来证实我们的发现,但机器人辅助的经纵隔食管切除术可能会给食管癌根治性手术带来短期的好处。
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引用次数: 0
263. DUPILUMAB EFFICACY AND SAFETY TO 52 WEEKS IN ADULT AND ADOLESCENT PATIENTS WITH EOSINOPHILIC ESOPHAGITIS: RESULTS FROM LIBERTY EOE TREET 263. Dupilumab治疗成人和青少年嗜酸性粒细胞性食管炎至52周的疗效和安全性:来自liberty eoe tree的结果
IF 2.6 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-08-30 DOI: 10.1093/dote/doad052.104
E. Dellon, M. Rothenberg, M. Collins, I. Hirano, M. Chehade, A. Bredenoord, A. Lucendo, J. Spergel, Xian Sun, J. Hamilton, E. Mortensen, Lila G. Glotfelty, A. Shabbir
In Parts A and B of the 3-part, phase 3 LIBERTY EoE TREET study (NCT03633617), dupilumab 300 mg weekly (DPL qw) vs placebo (PBO) demonstrated significant efficacy and acceptable safety up to 24 weeks in adults and adolescents with eosinophilic esophagitis (EoE). Patients who completed Parts A and B entered Part C and received DPL qw to 52 weeks. Here we present 52-week results from patients who completed Part B and continued to Part C. Of 80 DPL qw patients in Part B, 74 continued DPL qw in Part C (DPL/DPL). Of 79 PBO pts in Part B, 37 patients received DPL qw in Part C (PBO/DPL). Part B co-primary endpoints were proportion of patients achieving peak esophageal intraepithelial eosinophil (eos) count ≤6 eos/high- power field (hpf) and absolute change from Part B baseline in Dysphagia Symptom Score (DSQ) score at Week 24. Key secondary endpoints are listed in the Table. In Part C, all co-primary and secondary endpoints were assessed at Week 52 as secondary endpoints. Safety was also assessed. At Week 52, 84.6% of DPL/DPL and 67.6% of PBO/DPL patients achieved peak eos count ≤6 eos/hpf; mean (SD) absolute change from Part B baseline in DSQ score was −30.26 (15.39) for DPL/DPL and − 27.25 (11.46) for PBO/DPL patients. At Week 52, 100% of DPL/DPL and 78.4% of PBO/DPL patients achieved peak eos count <15 eos/hpf, 30.8% of DPL/DPL and 16.2% of PBO/DPL patients achieved peak eos count ≤1 eos/hpf, and compared to Part B baseline, peak eos count, EREFS, and HSS grade and stage scores were reduced (Table). DPL demonstrated an acceptable safety profile. DPL qw demonstrated persistent improvements in clinical, symptomatic, histologic, and endoscopic features of EoE up to 52 weeks and had an acceptable safety profile. PBO patients from Part B who received DPL in Part C showed similar efficacy to dupilumab qw patients of Part B.
在3部分3期LIBERTY-EoE TREET研究(NCT03633617)的A和B部分中,杜匹单抗每周300 mg(DPL-qw)与安慰剂(PBO)在患有嗜酸性食管炎(EoE)的成人和青少年中显示出显著的疗效和可接受的安全性,最长可达24周。完成A和B部分的患者进入C部分,接受DPL qw至52周。在这里,我们展示了完成B部分并继续进行C部分的患者52周的结果。在B部分的80名DPL qw患者中,C部分的74名继续DPL qw(DPL/DPL)。在B部分的79名PBO患者中,37名患者接受了C部分的DPL qw(PBO/DPL)。B部分的共同主要终点是在第24周达到食管上皮内嗜酸性粒细胞(eos)计数峰值≤6 eos/高功率场(hpf)的患者比例,以及吞咽困难症状评分(DSQ)评分与B部分基线相比的绝对变化。表中列出了关键的次要终点。在C部分中,在第52周评估所有共同主要和次要终点作为次要终点。还对安全性进行了评估。在第52周,84.6%的DPL/DPL和67.6%的PBO/DPL患者达到峰值eos计数≤6 eos/hpf;DPL/DPL的DSQ评分与B部分基线的平均(SD)绝对变化为−30.26(15.39) − PBO/DPL患者为27.25(11.46)。在第52周,100%的DPL/DPL和78.4%的PBO/DPL患者达到峰值eos计数<15 eos/hpf,30.8%的DPL/DPI和16.2%的PBO/DPI患者达到峰值eos计数≤1 eos/hpf,与B部分基线相比,峰值eos数、EREFS、HSS分级和分期得分降低(表)。DPL证明了可接受的安全状况。DPL-qw在EoE的临床、症状、组织学和内镜特征方面表现出持续改善,直至52周,并且具有可接受的安全性。在C部分接受DPL的来自B部分的PBO患者显示出与B部分的dupilumab qw患者相似的疗效。
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引用次数: 0
269. CURRENT STATUS OF THE INTRODUCTION PROCESS OF MINIMALLY INVASIVE TRANSCERVICAL ESOPHAGECTOMY (MICE), TYPICALLY IDEAL 2A STRUGGLES 269.微创经宫颈食管切除术(小鼠)的引入过程的现状,典型的理想2A斗争
IF 2.6 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-08-30 DOI: 10.1093/dote/doad052.108
B. Klarenbeek, L. Veenendaal, C. Rosman
The introduction of a novel complex surgical technique is a challenging process and can be associated with a long learning curve and learning-associated morbidity. In order to introduce Minimally Invasive transCervical Esophagectomy (MICE) in a safe way, the IDEAL framework was a used. MICE is an innovative surgical technique, combining a single-port transcervical mediastinal dissection with a laparoscopic transhiatal esophagectomy. MICE could reduce pulmonary complications and the consequences of anastomotic leakage, without compromising oncological radicality. Our five-step approach of the ‘pre-clinical stage 0’ made the IDEAL framework more applicable as a practical guideline and led to a safe ‘first-in-human procedure, IDEAL stage 1’. Currently we are prospectively collecting data of a single-center Radboudumc cohort, going through the learning curve and finetuning the surgical technique, which is typical for IDEAL stage 2A ‘Development’. In another abstract, the clinical outcomes of our single-center Radboudumc learning curve cohort will be presented. By the time of the 2023 ISDE conference, around 70 cases will be included. As a result of technical difficulties during the learning curve and succinct evaluation with peers and patients, several changes to the MICE procedure have been made, like: indications, cervical incision, continuous NIM, sequence of abdominal/cervical approach, camera system, extraction and reconstruction, conversion, surgical team. The surgical technique of MICE evolved during the collection of a singe-centre Radboudumc learning curve cohort. These changes are typical for the ‘IDEAL development stage 2A’, thorough evaluation of these changes might help limiting learning associated morbidity.
引入一种新的复杂手术技术是一个具有挑战性的过程,可能与长的学习曲线和学习相关的发病率有关。为了以安全的方式介绍微创经宫颈食管切除术(MICE),使用了IDEAL框架。MICE是一种创新的外科技术,将单端口经颈纵隔切除术与腹腔镜经食管切除术相结合。MICE可以减少肺部并发症和吻合口瘘的后果,而不会影响肿瘤学的激进性。我们的“临床前0阶段”的五步方法使IDEAL框架作为一项实用指南更加适用,并导致了安全的“人类第一阶段,IDEAL 1阶段”。目前,我们正在前瞻性地收集单中心Radboudumc队列的数据,通过学习曲线并微调手术技术,这是IDEAL 2A期“发展”的典型情况。在另一篇摘要中,我们将介绍单中心Radboudumc学习曲线队列的临床结果。到2023年ISDE会议召开时,将包括约70例病例。由于学习过程中的技术困难以及与同行和患者的简洁评估,对MICE程序进行了几项更改,如:适应症、颈部切口、连续NIM、腹部/颈部入路顺序、摄像系统、提取和重建、转换、手术团队。MICE的手术技术是在单一中心Radboudumc学习曲线队列的收集过程中发展起来的。这些变化是“理想发育阶段2A”的典型变化,对这些变化的彻底评估可能有助于限制学习相关的发病率。
{"title":"269. CURRENT STATUS OF THE INTRODUCTION PROCESS OF MINIMALLY INVASIVE TRANSCERVICAL ESOPHAGECTOMY (MICE), TYPICALLY IDEAL 2A STRUGGLES","authors":"B. Klarenbeek, L. Veenendaal, C. Rosman","doi":"10.1093/dote/doad052.108","DOIUrl":"https://doi.org/10.1093/dote/doad052.108","url":null,"abstract":"\u0000 \u0000 \u0000 The introduction of a novel complex surgical technique is a challenging process and can be associated with a long learning curve and learning-associated morbidity. In order to introduce Minimally Invasive transCervical Esophagectomy (MICE) in a safe way, the IDEAL framework was a used.\u0000 \u0000 \u0000 \u0000 MICE is an innovative surgical technique, combining a single-port transcervical mediastinal dissection with a laparoscopic transhiatal esophagectomy. MICE could reduce pulmonary complications and the consequences of anastomotic leakage, without compromising oncological radicality. Our five-step approach of the ‘pre-clinical stage 0’ made the IDEAL framework more applicable as a practical guideline and led to a safe ‘first-in-human procedure, IDEAL stage 1’. Currently we are prospectively collecting data of a single-center Radboudumc cohort, going through the learning curve and finetuning the surgical technique, which is typical for IDEAL stage 2A ‘Development’.\u0000 \u0000 \u0000 \u0000 In another abstract, the clinical outcomes of our single-center Radboudumc learning curve cohort will be presented. By the time of the 2023 ISDE conference, around 70 cases will be included. As a result of technical difficulties during the learning curve and succinct evaluation with peers and patients, several changes to the MICE procedure have been made, like: indications, cervical incision, continuous NIM, sequence of abdominal/cervical approach, camera system, extraction and reconstruction, conversion, surgical team.\u0000 \u0000 \u0000 \u0000 The surgical technique of MICE evolved during the collection of a singe-centre Radboudumc learning curve cohort. These changes are typical for the ‘IDEAL development stage 2A’, thorough evaluation of these changes might help limiting learning associated morbidity.\u0000 \u0000","PeriodicalId":11354,"journal":{"name":"Diseases of the Esophagus","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2023-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43006615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
471. MINIMALLY INVASIVE ESOPHAGECTOMY WITH RESECTION OF THE DESCENDING AORTA DUE TO SUSPECTED TUMOR INFILTRATION 471. 怀疑肿瘤浸润行微创食管切除术并切除降主动脉
IF 2.6 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-08-30 DOI: 10.1093/dote/doad052.253
M. Menéndez, M. Bruna, J. Vaqué, Nuria García Del Olmo, Fernando Mingol Navarro, M.L. Nieto
Classically, esophageal neoplasms have had a poor survival, considering those T4b tumors that infiltrate the aorta, airways or vertebrae to be unresectable despite not having distant disease. With the advancement of surgical techniques, the improvement of neoadjuvant/adjuvant systemic treatments and the multidisciplinary approach to this pathology, these barriers of unresectability are gradually being broken. This is a 68-year-old patient, a 1-pack-a-day smoker, who presented squamous cell carcinoma 30 cm from the dental arch treated with chemoradiotherapy according to the CROSS scheme. After surgery at another center, there is suspicion of infiltration of the descending aorta, for which he was referred to our center. The case is discussed in a multidisciplinary committee and a decision is made to place TEVAR in the first stage and surgical resection of the lesion in a second stage. The patient underwent surgery performing a three-stage esophagectomy (McKeown) using prone thoracoscopy without selective intubation, through which a regulated esophagectomy was performed with total lymphadenectomy and en bloc resection along with the anterior wall of the descending aorta where there was suspicion of tumor infiltration, exposing the aortic prosthesis (Photo 2). The prosthesis is covered to isolate it from possible sources of infection with a patch of pericardium fixed with loose sutures to the aortic wall and biological glue. It was reconstructed using a mediastinal gastroplasty with cervical circular mechanical anastomosis. Postoperative period marked by cervical leakage that was resolved by conservative treatment. Resection using a minimally invasive approach of an aortic patch in cases of suspected tumor infiltration in esophageal neoplasms without systemic disease may be a safe therapeutic option as long as it is performed in centers specialized in complex esophageal resections and with a multidisciplinary team that also involves cardiac surgeons. The oncological prognosis must be evaluated in the long term, but achieving R0 resections should not be worse than in locally advanced resectable tumors.
传统上,食道肿瘤的生存率很低,因为那些浸润主动脉、气道或椎骨的T4b肿瘤尽管没有远处病变,但无法切除。随着手术技术的进步,新辅助/辅助系统治疗的完善以及多学科治疗方法的发展,这些不可切除的障碍正在逐渐被打破。这是一位68岁的患者,每天抽一包烟,在距牙弓30厘米处出现鳞状细胞癌,根据CROSS方案进行了放化疗。在另一中心手术后,怀疑降主动脉浸润,因此他被转介到我中心。多学科委员会对该病例进行了讨论,并决定将TEVAR置于第一阶段,手术切除病变置于第二阶段。患者行三期食管切除术(McKeown),手术采用俯卧胸腔镜,无选择性插管,在怀疑有肿瘤浸润的降主动脉前壁行全淋巴结切除和整体切除的调节食管切除术。露出主动脉假体(图2)。将假体覆盖在心包上,将其与可能的感染源隔离,并将其与主动脉壁松散缝合和生物胶固定。采用纵隔胃成形术和颈部环形机械吻合术重建。术后以宫颈渗漏为特征,经保守治疗得以解决。在没有全身性疾病的食管肿瘤疑似肿瘤浸润的情况下,只要在专门从事复杂食管切除术的中心和包括心脏外科医生在内的多学科团队中进行,采用主动脉补片的微创方法切除可能是一种安全的治疗选择。肿瘤预后必须进行长期评估,但实现R0切除不应比局部晚期可切除的肿瘤差。
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引用次数: 0
434. INCREASING TUMOUR INFILTRATING LYMPHOCYTES THROUGH EXERCISE ALONE—A PILOT RCT IN ESOPHAGEAL ADENOCARCINOMA 434. 仅通过运动增加肿瘤浸润淋巴细胞-食管癌的先导随机对照试验
IF 2.6 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-08-30 DOI: 10.1093/dote/doad052.226
Charles Rayner, S. Allen, Tadd Seymour, S. Preston, A. Frampton, D. Bartlett, N. Annels, N. Abbassi‐Ghadi
The immune system is highly responsive and positively adapts to exercise. A single bout of exercise results in the mobilisation of highly functional effector CD8+ T cells and NK-cells into the circulation. Murine cancer models have shown that exercise reduces tumour burden by increasing the frequency of tumour-infiltrating lymphocytes (TILs). There are no studies assessing the impact of an exercise programme on the levels of TILs in patients’ solid tumours in any cancer. We recently completed a 16-week randomised prehabilitation exercise program (NCT02950324) in esophageal cancer patients before esophagogastric cancer resection. Exercise training was a low-to-moderate intensity twice supervised, thrice home-based weekly program. Tumour specimens obtained at the time of resection were formalin fixed paraffin embedded (FFPE) for multispectral immunohistochemical analysis. Tumour tissues were stained with primary antibodies for CD68, CD57, CD8, CD4, FoxP3, Granzyme B, PDL1 and pancytokeratin. Cell populations and spatial relationships were analysed using the Phenoimager HT (Akoya Biosciences) and QuPath. Although our exercise program was ~33% of the physical activity guidelines for cancer patients, physical fitness and well-being were maintained rather than significantly reduced in the intervention group compared to the control group. Multispectral analysis observed that 3.2% ± 1.1% of cells in the tumours were CD8+ T cells compared to 1.4% ± 0.5% in the control group (p < 0.001). Furthermore, we observed positive associations between increased frequencies of CD8 + TILs (Fig 1C: r = 0.562, p = 0.016), Granzyme B+/CD8 + TILs (r = 0.637, p = 0.003) and larger increases in exercise induced aerobic capacity. This data suggests that the more exercise can increase aerobic fitness, the greater the likelihood of increasing functional TILs. New approaches to improve outcomes following surgery for esophageal adenocarcinoma are required. One such approach is immunotherapy. However, immunotherapy is relatively ineffective in esophageal adenocarcinoma due to the lack of CD8+ T cells and NK cells in the tumours. Increasing TILs through exercise programmes that are designed to focus on maintaining or improving aerobic capacity may improve patients’ response to immunotherapy and positively impact prognosis and survival.
免疫系统反应强烈,对运动有积极的适应能力。单次运动会导致高功能效应CD8+T细胞和NK细胞进入循环。小鼠癌症模型表明,运动通过增加肿瘤过滤淋巴细胞(TIL)的频率来减少肿瘤负担。没有研究评估锻炼计划对任何癌症患者实体瘤中TIL水平的影响。我们最近完成了一项为期16周的随机康复锻炼计划(NCT02950324),该计划针对食管胃癌症切除术前的癌症患者。运动训练是一种低到中等强度的训练,每周两次监督,三次在家进行。切除时获得的肿瘤标本是福尔马林固定石蜡包埋(FFPE),用于多光谱免疫组织化学分析。肿瘤组织用CD68、CD57、CD8、CD4、FoxP3、颗粒酶B、PDL1和泛细胞角蛋白的一级抗体染色。使用Phenoimager HT(Akoya Biosciences)和QuPath分析细胞群和空间关系。尽管我们的锻炼计划约为癌症患者体力活动指南的33%,但与对照组相比,干预组的体能和幸福感得到了保持,而不是显著降低。多光谱分析发现3.2% ± 肿瘤中1.1%的细胞是CD8+T细胞,而这一比例为1.4% ± 对照组为0.5%(p < 0.001)。此外,我们观察到CD8频率增加之间的正相关 + 瓷砖(图1C:r = 0.562,p = 0.016)、粒酶B+/CD8 + TIL(r = 0.637,p = 0.003)和运动诱导的有氧能力的较大增加。这些数据表明,运动越多,有氧健身能力越强,增加功能性TIL的可能性就越大。需要新的方法来改善食管腺癌手术后的结果。其中一种方法是免疫疗法。然而,由于肿瘤中缺乏CD8+T细胞和NK细胞,免疫疗法在食管腺癌中相对无效。通过旨在保持或提高有氧能力的运动计划增加TIL,可以改善患者对免疫疗法的反应,并对预后和生存产生积极影响。
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引用次数: 0
15. EFFECT OF ARTIFICIAL CAPNOTHORAX VS NON-CAPNOTHORAX DURING THORACOSCOPIC ESOPHAGECTOMY ON CIRCULATING TUMOR CELLS AND SURVIVAL IN ESOPHAGEAL CANCER 15. 胸腔镜食管切除术中人工羊膜胸与非羊膜胸对食管癌循环肿瘤细胞及生存的影响
IF 2.6 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-08-30 DOI: 10.1093/dote/doad052.003
Y. Gu, Wen-ping Wang, Long-Qi Chen
To investigate the effect of artificial capnothorax on circulating tumor cells and survival after minimally invasive esophagectomy for esophageal cancer. This prospective, multicenter, randomized controlled trial was conducted in a tertiary hospital in China. Between August 2019 and January 2020, 110 patients with resectable esophageal cancer were randomized to undergo non-capnothorax esophagectomy (n = 55) or capnothorax procedures. The analysis was based on the intention-to-treat principle. The final follow-up occurred in November 2022. The main outcomes were changes in folate receptor-positive circulating tumor cells, 3-year overall survival, and disease-free survival rates. A total of 110 patients were included in the intention-to-treat analysis. After surgery, the incidence of patients with incremental changes in FR + CTC levels was 18.6% (8/43) in the capnothorax group and 2.7% (1/37) in the non-capnothorax group (P = 0.033) (mean changes, −3.9 ± 3.4 [FU/3 mL] vs −2.4 ± 2.9 [FU/3 mL], respectively; P = 0.039). There were significant differences in the 3-year overall survival rate (81.6% [95%, 72.4–92.0] vs 65.2% [95%, 59.3–78.8]; P = 0.002) and disease-free survival rate (81.6% [95%, 72.4–93.0] vs 61.6% [95%, 50.1–75.7]; P = 0.015) between the two groups. Multivariate analysis indicated that the artificial pneumothorax approach was a prognostic factor for overall survival (HR: 2.347, 95% CI: 1.053–5.235; P = 0.037) and disease-free survival (HR: 1.325, 95% CI: 1.210–1.451; P < 0.001). Artificial capnothorax during surgery resulted in increased dissemination of circulating tumor cells and worse survival outcomes in patients with esophageal cancer. Esophagectomy under non-capnothorax should be a recommended procedure.
探讨人工capnothorax对癌症食管微创切除术后循环肿瘤细胞及生存率的影响。这项前瞻性、多中心、随机对照试验在中国一家三级医院进行。在2019年8月至2020年1月期间,110名可切除食管癌症患者被随机分配接受非呼吸暂停性食管切除术(n = 55)或capnothorax程序。分析是基于意向治疗原则。最后一次随访发生在2022年11月。主要结果是叶酸受体阳性循环肿瘤细胞的变化、3年总生存率和无病生存率。共有110名患者被纳入意向治疗分析。术后FR发生增量变化的患者的发生率 + CTC水平在催眠组为18.6%(8/43),在非催眠组为2.7%(1/37)(P = 0.033)(平均变化,−3.9 ± 3.4[FU/3 mL]vs−2.4 ± 分别为2.9[FU/3mL];P = 0.039)。三年总生存率有显著差异(81.6%[95%,72.4-92.0]与65.2%[95%,59.3-78.8];P = 0.002)和无病生存率(81.6%[95%,72.4-93.0]vs 61.6%[95],50.1-75.7];P = 0.015)。多因素分析表明,人工流产是总生存率的预后因素(HR:2.347,95%CI:1.053–5.235;P = 0.037)和无病生存率(HR:1.325,95%CI:12.10-1.451;P < 0.001)。手术期间人工capnothorax导致食管癌症患者循环肿瘤细胞的扩散增加和更差的生存结果。食管切除术在非催眠疗法下应该是一个推荐的程序。
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Diseases of the Esophagus
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