Distribution of lymph node metastases in esophageal carcinoma [TIGER]
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- The distribution of lymph node metastases in esophageal and esophago-gastric junction carcinoma specimens following transthoracic esophagectomy with at least 2-field lymphadenectomy in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and (disease free) survival.
研究概览
简要总结
Lymph node status is an important prognostic parameter in esophageal carcinoma and an independent predictor of survival. Distribution of metastatic lymph nodes may vary with tumor location, tumor histology, tumor invasion depth, and neo-adjuvant therapy. The surgical strategy depends on the distribution pattern of nodal metastases but consensus on the extent of lymphadenectomy differs worldwide. Especially for adenocarcinoma, the distribution of lymph node metastases has not yet been described in large series.
Aim of the present study is to evaluate the distribution of lymph node metastases in esophageal carcinoma specimens following transthoracic esophagectomy with at least a 2-field lymphadenectomy.
This multicenter prospective observational study will help to determine the distribution of lymph node metastases in all patients with resectable esophageal or gastro-esophageal junction carcinoma in whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed in order to develop a uniform worldwide staging system and to establish the optimal surgical strategy for esophageal cancer patients. This will also support optimal treatment of Indian patients with esophageal cancer.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary squamous cell or adenocarcinoma of the esophagus or esophagogastric junction
- •Surgically resectable (cT1-4a, N0-3, M0)
- •Adequate physical condition to undergo transthoracic surgery (ASA 1-3)
- •Transthoracic esophagectomy
- •18 Years and above.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach
- •Patients with in situ carcinoma or high-grade dysplasia.
结局指标
主要结局
The distribution of lymph node metastases in esophageal and esophago-gastric junction carcinoma specimens following transthoracic esophagectomy with at least 2-field lymphadenectomy in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and (disease free) survival.
时间窗: Demographic | Pre Operative | Per Operative | Post Operative
次要结局
- Accuracy of preoperative diagnostics (especially EUS and PET-CT) and added value of EBUS to existing staging with EUS/PET-CT(Analysis of the phenomenon skip nodal metastases)