Distribution of lymph node metastases in esophageal carcinoma [TIGER study]: study protocol of a multinational observational study.
Eliza R C Hagens, Mark I van Berge Henegouwen, Johanna W van Sandick...
https://pubmed.ncbi.nlm.nih.gov/31272485Actively Recruiting
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-02-13
5000
Participants Needed
19
Research Sites
178 weeks
Total Duration
Researchers are evaluating the distribution of lymph node metastases in patients with esophageal or gastro-esophageal junction carcinoma who undergo transthoracic esophagectomy with at least a two-field lymphadenectomy. This multinational observational study aims to better understand how lymph node spread varies by tumor location, histology, invasion depth, and use of neoadjuvant therapy. By studying these patterns in a large patient group, the research seeks to inform more tailored treatments, such as optimal radiation fields and surgical approaches. This study includes all patients with resectable esophageal carcinoma undergoing transthoracic esophagectomy with two- or three-field lymphadenectomy in participating centers across 18 countries. All lymph node stations removed during surgery are examined separately. The study will analyze patterns of metastases in relation to tumor characteristics and treatment history, including the use of neoadjuvant chemoradiotherapy. No additional procedures are performed beyond standard care. Participants will be followed for five years after surgery according to national guidelines, with regular follow-up visits scheduled every three months in the first year, every six months during years two to four, and annually in the fifth year. Researchers will collect data on lymph node involvement, recurrence patterns, survival outcomes, and diagnostic accuracy. This information will help identify subgroups of patients with different metastasis patterns and assess long-term disease-free and overall survival.
CONDITIONS
Distribution of Lymph Node Metastases in Esophageal Carcinoma
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration as per routine care
Participants undergo transthoracic esophagectomy with at least 2-field lymphadenectomy according to national guidelines.
Hospital stay with standard post-operative assessments
Duration - 5 years
Participants are followed up for 5 years after surgery to monitor recurrence, survival, and other outcomes according to national guidelines.
Follow-up visits every 3 months for the first year, every 6 months from year 2 to 4, then annually in year 5
Total: 19 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
Instituto Nacional de Câncer
Rio de Janeiro, Brazil
Actively Recruiting
3
University of Toronto
Toronto, Canada
Actively Recruiting
4
Fudan University Shanghai Cancer Center
Shanghai, Yangpu, China, 200032
Actively Recruiting
5
Hospital District of Helsinki and Uusimaa
Helsinki, Finland, 000260
Actively Recruiting
6
University Medical Center of the Johannes Gutenberg University
Mainz, Germany, 55131
Actively Recruiting
7
University of Athens, School of Medicine
Athens, Greece, 11527
Actively Recruiting
8
University of Hong Kong
Hong Kong, Hong Kong, 102
Actively Recruiting
9
Tata Memorial Centre
Mumbai, India
Actively Recruiting
10
IRCCS Policlinico San Donato
Milan, Italy, 20097
Actively Recruiting
11
Ospedale San Raffaele
Milan, Italy
Actively Recruiting
12
University of Verona
Verona, Italy, 37129
Actively Recruiting
13
Uonuma Institute and Niigata University
Niigata, Japan, 9502292
Actively Recruiting
14
Keio University School of Medicine
Tokyo, Japan, 1088345
Actively Recruiting
15
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 1358550
Actively Recruiting
16
Ziekenhuisgroep Twente, Almelo & Hengelo
Almelo, Netherlands
Actively Recruiting
17
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
18
Hospital Universitario del Mar
Barcelona, Spain, 08003
Actively Recruiting
19
Karolinska Institutet
Stockholm, Sweden, 17177
Actively Recruiting
S
Suzanne S Gisbertz, MD, PhD
E
Eliza RC Hagens, BSc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Eliza R C Hagens, Mark I van Berge Henegouwen, Johanna W van Sandick...
https://pubmed.ncbi.nlm.nih.gov/31272485