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Clinical Trials in India / NCT03222895
Recruiting Observational

Distribution of Lymph Node Metastases in Esophageal Carcinoma

NCT03222895 · tracked via the Priya Life Science India tracker
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase
Observational
Started
2019-03-01
Last updated
2024-02-13

Condition(s) studied

Esophageal NeoplasmsLymph Node Metastases

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach * Patients with in situ carcinoma or high grade dysplasia

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
MD Anderson Cancer Center Houston Texas Recruiting
Instituto Nacional de Câncer Rio de Janeiro Brazil Recruiting
University of Toronto Toronto Canada Recruiting
Fudan University Shanghai Cancer Center Shanghai Yangpu Recruiting
Hospital District of Helsinki and Uusimaa Helsinki Finland Recruiting
University Medical Center of the Johannes Gutenberg University Mainz Germany Recruiting
University of Athens, School of Medicine Athens Greece Recruiting
University of Hong Kong Hong Kong Hong Kong Recruiting
Tata Memorial Centre Mumbai India Recruiting
IRCCS Policlinico San Donato Milan Italy Recruiting
Ospedale San Raffaele Milan Italy Recruiting
University of Verona Verona Italy Recruiting
Uonuma Institute and Niigata University Niigata Japan Recruiting
Keio University School of Medicine Tokyo Japan Recruiting
The Cancer Institute Hospital of JFCR Tokyo Japan Recruiting
Ziekenhuisgroep Twente, Almelo & Hengelo Almelo Netherlands Recruiting
Amsterdam UMC Amsterdam Netherlands Recruiting
Hospital Universitario del Mar Barcelona Spain Recruiting
Karolinska Institutet Stockholm Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03222895 on ClinicalTrials.gov ↗ ← All trials in India