Distribution of Lymph Node Metastases in Esophageal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 19
- 主要终点
- Distribution of lymph node metastases
研究概览
简要总结
Background: 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 neoadjuvant therapy. 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.
Methods: The TIGER-study is a multinational observational cohort study. All patients with a resectable esophageal or gastro-esophageal junction carcinoma in whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed in participating centers will be included. All lymph node stations will be excised and separately sent for pathological examination. Cluster analysis will be performed to identify patterns of metastases in relation to tumor location, tumor histology, tumor invasion depth and neoadjuvant therapy.
Conclusion: TIGER will provide a roadmap of the location of lymph node metastases in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and survival. Patient-tailored treatment can be developed on the basis of these results, such as the the optimal radiation field and extent of lymphadenectomy based on the primary tumor characteristics.
详细描述
Primary Objective:
Aim of the TIGER study is to evaluate the distribution of lymph node metastases in esophageal carcinoma specimens following transthoracic esophagectomy with at least 2-field lymphadenectomy.
Secondary Objective(s):
- Accuracy of preoperative diagnostics (especially EUS and PET-CT) and added value of EBUS (endobronchial ultrasonography) to existing staging with EUS (endoscopic ultrasonography)/PET-CT
- Prognostic value of different lymph node stations
- Three- and 5-year overall and disease free survival
- Distribution pattern of recurrence or metastases
- Number of harvested lymph nodes in patients who are treated with and without neo-adjuvant chemoradiotherapy
- Frequency of skip nodal metastases
- Ratio of nodal metastases inside and outside the radiation field o Lymph node metastases will be defined as inside or outside the radiation field nodes.
Study design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary squamous cell or adenocarcinoma of the esophagus or esophago-gastric junction
- •Surgically resectable (cT1-4a, N0-3, M0)
- •Adequate physical condition to undergo transthoracic surgery (ASA 1-3)
- •Transthoracic esophagectomy
排除标准
- •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
Distribution of lymph node metastases
时间窗: 2 years
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.
次要结局
- Prognostic value of different lymph node stations(2 years)
- Skip nodal metastases(2 years)
- Accuracy of preoperative diagnostics(2 years)
- Number of harvested lymph nodes in patients who are treated with and without neo-adjuvant chemoradiotherapy(2 years)
- Ratio of nodal metastases inside and outside the radiation field(2 years)
- Distribution pattern of recurrence or metastases(2 years)
- 3- and 5-year overall and disease free survival(7 years)
研究者
S.S. Gisbertz
Upper GI Surgeon
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)