Distribution of Lymph Node Metastases in Esophageal Carcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 1 trial group
Group A: TIGER study cohort

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

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

Time frame
2 years
2

Prognostic value of different lymph node stations

Prognostic value of different lymph node stations

Time frame
2 years
3

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

Time frame
2 years
4

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

Time frame
2 years

Other outcomes

Sponsors and contacts

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