About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach
Patients with in situ carcinoma or high grade dysplasia
Trial population
All patients with esophageal cancer who will undergo a transthoracic esophagectomy with a 2- or 3 field lymphadenectomy for esophageal cancer in one of the participating centers during the inclusion period.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Distribution of lymph node metastases
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.
Secondary outcomes
Accuracy of preoperative diagnostics
Accuracy of preoperative diagnostics (especially EUS and PET-CT) and added value of EBUS to existing staging with EUS/PET-CT
Prognostic value of different lymph node stations
Prognostic value of different lymph node stations
Distribution pattern of recurrence or metastases
Distribution pattern of recurrence or metastases, In-field- or out-field nodal recurrence in case of neo-adjuvant chemoradiation
Number of harvested lymph nodes in patients who are treated with and without neo-adjuvant chemoradiotherapy
Number of harvested lymph nodes in patients who are treated with and without neo-adjuvant chemoradiotherapy
Sponsors and contacts
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