RecruitingNCT03222895

Distribution of Lymph Node Metastases in Esophageal Carcinoma


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

5,000 participants

Start Date

Mar 1, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria2

  • Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach
  • Patients with in situ carcinoma or high grade dysplasia

Locations(19)

MD Anderson Cancer Center

Houston, Texas, United States

Instituto Nacional de Câncer

Rio de Janeiro, Brazil

University of Toronto

Toronto, Canada

Fudan University Shanghai Cancer Center

Shanghai, Yangpu, China

Hospital District of Helsinki and Uusimaa

Helsinki, Finland

University Medical Center of the Johannes Gutenberg University

Mainz, Germany

University of Athens, School of Medicine

Athens, Greece

University of Hong Kong

Hong Kong, Hong Kong

Tata Memorial Centre

Mumbai, India

IRCCS Policlinico San Donato

Milan, Italy

Ospedale San Raffaele

Milan, Italy

University of Verona

Verona, Italy

Uonuma Institute and Niigata University

Niigata, Japan

Keio University School of Medicine

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Ziekenhuisgroep Twente, Almelo & Hengelo

Almelo, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

Hospital Universitario del Mar

Barcelona, Spain

Karolinska Institutet

Stockholm, Sweden

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NCT03222895


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