Tiger Study Synopsis

Title

Distribution of lymph node metastases in esophageal carcinoma

Short title

TIGER Study

Design

Multicenter, multinational, observational cohort study

Participants

Patients with a resectable esophageal or gastroesophageal junction carcinoma in whom a transthoracic esophagectomy with an at least 2-field lymphadenectomy is performed.

Inclusion criteria

  •  Primary squamous cell or adenocarcinoma of the esophagus or esophagogastric 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 objective

 To evaluate the distribution of lymph node metastases in esophageal carcinoma specimens following transthoracic esophagectomy with at least 2-field lymphadenectomy.

Secondary objectives

  • The accuracy of preoperative diagnostics (especially EUS and PET-CT) and added value of EBUS to existing staging with EUS/PET-CT
  • Prognostic value of different lymph node stations
  • Three- and 5-year overall and disease-free survival
  • The distribution pattern of recurrence or metastases
  • Number of harvested lymph nodes in patients who are treated with and without neoadjuvant chemoradiotherapy
  • The frequency of skip nodal metastases
  • The ratio of nodal metastases inside and outside the radiation field

Lymph node metastases will be defined as inside or outside the radiation field nodes.

Planned Sample Size

We aim to include 5000 patients. This number suffices for (i) descriptive purposes and (ii) clustering of metastases diffusion profiles into meaningful subgroups within predefined strata (patients with adenocarcinoma or squamous cell carcinoma, with and without neoadjuvant therapy, different tumor heights and invasion depths, and following a 2- or 3-field lymphadenectomy).

Total study duration

Seven years (2 years inclusion, 5 years follow-up)

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