Recruiting

Observational Study

Sponsor:

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

Code:

NCT03222895

Conditions

Esophageal Neoplasms

Lymph Node Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Esophageal Neoplasms

Lymph Node Metastases

Study ID

NCT03222895

Start date

Mar 1, 2019

Status verified date

Feb, 2024

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

TIGER study cohort

This is the entire patient cohort. Alle patients with resectable esophageal cancer undergoing a transthoracic esophagectomy with at least a 2-field lymphadenectomy

Primary outcome measure

  • Distribution of lymph node metastases [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Suzanne S Gisbertz, MD, PhD

+31205669111s.s.gisbertz@amc.nl

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

University of Toronto

Recruiting

Toronto, Canada

More Information

Sponsor

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

Last update posted

Feb 13, 2024

Last verified

Feb, 2024

Keywords

  • Esophageal Neoplasms
  • Lymph node metastases
  • Esophagectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) on 2024-02-13.