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临床试验/NCT01770275
NCT01770275已完成不适用

An Attempt at Validation of the Seventh Edition of the Classification by the International Union Against Cancer for Esophageal Carcinoma

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 605 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
605
试验地点
1
主要终点
Overall survival

研究概览

简要总结

Background. The aim of our study was to investigate the ability of the Seventh edition of the classification by the International Union Against Cancer (UICC) to identify patients at higher risk and to predict the overall survival in patients with esophageal carcinoma. Methods. Demographic and clinical data of 605 patients, who underwent esophagectomy for esophageal carcinoma between 1992 and 2009, were analyzed. Tumor stage and grade were classified according to the sixth and seventh editions of the UICC classification.

详细描述

Patients

The University-Hospital Hamburg-Eppendorf is a specialist reference centre for the treatment of patients with esophageal carcinoma in Germany. A prospective database for all patients with surgically resectable esophageal carcinoma was established in 1992 at the Department for General, Visceral and Thoracic Surgery at the University Hospital Hamburg-Eppendorf, Germany. Only patients without perioperative chemotherapy and histologically proven esophageal cancer were included into this study. The demographic, clinical, operative and postoperative courses of each patient were collected. Informed consent was obtained from all patients before including them in the prospective database. The study was approved by the Medical Ethical Committee of the chamber of physicians of Hamburg.

Surgical procedures in patients with esophageal carcinomas encompassed either transhiatal (TH) or thoracoabdominal (TA) esophagectomy. The thoraco-abdominal (Ivor - Lewis) esophagectomies were performed by right-sided thoracotomy, median inverse T-shaped laparotomy, and left-sided cervicotomy for collar anastomosis until mid 2003. From mid 2003 onward the anastomosis was done highly intrathoracically. A wide peritumoral resection was performed including an en bloc subtotal esophageal resection with dissection of the right-sided paratracheal, aortopulmonary window, subcarinal, mediastinal, and paracardial lymph nodes. The azygos vein was also resected. An extensive lymphadenectomy of the upper abdominal compartment (D-II lymphadenectomy, including the paracardial nodes, the left gastric artery nodes along with the lymph nodes of the lesser curvature of the stomach, the celiac trunk, the common hepatic artery, and the splenic artery) was conducted.

The transhiatal esophagectomies consisted of an inversed T-shaped laparotomy, followed by wide peritumoral dissection of the distal esophagus and abdominal lymph node dissection of the upper abdominal compartment (D-II lymphadenectomy), and a dissection of the lymph nodes of the posterior mediastinum extending as far as the main carina of the trachea. Above the tracheal bifurcation, the dissection was continued bluntly using digital dissection and staying close to the esophageal wall.

Follow-Up

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with esophageal cancer
  • > 18 years

排除标准

  • 未提供

结局指标

主要结局

Overall survival

时间窗: 5 years

次要结局

  • Survival distinction(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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