RECRUITING

Distribution of Lymph Node Metastases in Esophageal Carcinoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Distribution of Lymph Node Metastases in Esophageal Carcinoma

Quick Facts

Study Start:2019-03-01
Study Completion:2028-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03222895

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary squamous cell or adenocarcinoma of the esophagus or esophago-gastric junction
  2. * Surgically resectable (cT1-4a, N0-3, M0)
  3. * Adequate physical condition to undergo transthoracic surgery (ASA 1-3)
  4. * Transthoracic esophagectomy
  1. * Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach
  2. * Patients with in situ carcinoma or high grade dysplasia

Contacts and Locations

Study Contact

Suzanne S Gisbertz, MD, PhD
CONTACT
+31205669111
s.s.gisbertz@amc.nl
Eliza RC Hagens, BSc
CONTACT
+31205669111
e.r.hagens@amc.uva.nl

Principal Investigator

Suzanne S Gisbertz, MD, PhD
STUDY_CHAIR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Mark I van Berge Henegouwen, MD, PHD
PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eliza RC Hagens, MD
STUDY_DIRECTOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Locations (Sites)

MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

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

  • Suzanne S Gisbertz, MD, PhD, STUDY_CHAIR, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Mark I van Berge Henegouwen, MD, PHD, PRINCIPAL_INVESTIGATOR, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Eliza RC Hagens, MD, STUDY_DIRECTOR, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-01
Study Completion Date2028-06-01

Study Record Updates

Study Start Date2019-03-01
Study Completion Date2028-06-01

Terms related to this study

Keywords Provided by Researchers

  • Esophageal Neoplasms
  • Lymph node metastases
  • Esophagectomy

Additional Relevant MeSH Terms

  • Esophageal Neoplasms
  • Lymph Node Metastases