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临床试验/NCT01766986
NCT01766986已完成不适用

Staging and Outcome Depending on Surgical Treatment in Adenocarcinomas of the Oesophagogastric Junction

Universitätsklinikum Hamburg-Eppendorf0 个研究点目标入组 130 人开始时间: 2008年1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
130
主要终点
Overall Survival

研究概览

简要总结

Background: Owing to controversial staging and classification of adenocarcinoma of the oesophagogastric junction (AOG) before surgery, the choice of appropriate surgical approach remains problematic.

In a retrospective study, preoperative staging of AOG and the impact of preoperative misclassification on outcome were analysed. Methods: Data from patients with AOG were analysed from a prospectively collected database with regard to surgical treatment, preoperative and postoperative staging, and outcome.

详细描述

A prospective database of all patients with surgically resectable esophageal, cardia and gastric carcinomas was established in 1992 at the Department for General, Visceral and Thoracic Surgery at the University Hospital Hamburg-Eppendorf, Germany. Only patients without neoadjuvant therapy and histologically proven AEG type I and II 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 which was approved by the Medical Ethical Committee of the chamber of physicians of Hamburg.

Preoperative examinations of patients included physical examination, routine blood tests, plain chest radiography, abdominal ultrasonography, endoscopy, endosonography (EUS), computed tomography (CT) of the chest and abdomen as well as positron emission tomography (PET)-CT after January 2006 and studies of tumor markers (CEA, CA 19-9), in selected patients. Tumour localization was defined according the Siewert classification (3) based upon endoscopy, endosonography and intraoperative assessment of the respective surgeon.

All patients undergoing a thoracoabdominal esophagectomy (TA) were operated with a right-sided thoracotomy, and a median inverse T-shaped laparotomy. Peritumoral resection included an en bloc subtotal esophageal resection with dissection of the right-sided paratracheal, aortopulmonary window, subcarinal and mediastinal lymph nodes (LN) and the azygos vein and a collar or high intrathoracically anastomosis. An extensive lymphadenectomy of the upper abdominal compartment (D-II lymphadenectomy, including the paracardial, the left gastric artery nodes along with the LN of the lesser and greater curvature of the stomach, the prepyloric LN, the celiac trunk, the common hepatic artery, the LN in the hepathoduodenal ligament and the LN at the splenic artery) was conducted.

The transhiatal esophagectomy (TH) consisted of an inversed T-shaped laparotomy, a wide peritumoral dissection of the distal esophagus, DII lymphadenectomy and a dissection of the LN of the posterior mediastinum extending as far as the carina of the trachea.

Extended gastrectomy (EG) consisted of an inversed T-shaped laparotomy, a gastrectomy with resection of the distal esophagus, D-II lymphadenectomy plus dissection of the lower posterior mediastinum LN. The reconstruction included a jejunal loop with a J-pouch.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • One-hundred and thirty patients with Siewert types I and II AOG who did not have neoadjuvant treatment were included in the study

排除标准

  • AOG type III
  • no surgical resection

结局指标

主要结局

Overall Survival

时间窗: 36 months

Overall survival after surgery (months)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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